Trial Outcomes & Findings for 68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa) (NCT NCT03490032)
NCT ID: NCT03490032
Last Updated: 2020-11-17
Results Overview
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
dosing through 28 days post-dose
Results posted on
2020-11-17
Participant Flow
This study was conducted at 5 centers in the USA (Phase I: 1 site; Phase II: 4 sites)
Participant milestones
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
12
|
|
Overall Study
COMPLETED
|
5
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Overall Study
family issue (child custody)
|
1
|
0
|
0
|
Baseline Characteristics
68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)
Baseline characteristics by cohort
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.2 Years
STANDARD_DEVIATION 7.91 • n=5 Participants
|
69.1 Years
STANDARD_DEVIATION 6.53 • n=7 Participants
|
68.6 Years
STANDARD_DEVIATION 10.00 • n=5 Participants
|
68.3 Years
STANDARD_DEVIATION 8.13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
ECOG Performance Status
Grade 0
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
ECOG Performance Status
> = Grade 1
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Prostate-specific antigen (PSA) levels
|
1.68 ng/mL
STANDARD_DEVIATION 1.329 • n=5 Participants
|
3.72 ng/mL
STANDARD_DEVIATION 6.461 • n=7 Participants
|
38.56 ng/mL
STANDARD_DEVIATION 66.603 • n=5 Participants
|
17.25 ng/mL
STANDARD_DEVIATION 44.861 • n=4 Participants
|
|
Time since first prostate cancer diagnosis
|
79.2 Months
STANDARD_DEVIATION 46.44 • n=5 Participants
|
86.8 Months
STANDARD_DEVIATION 78.07 • n=7 Participants
|
96.1 Months
STANDARD_DEVIATION 84.80 • n=5 Participants
|
88.8 Months
STANDARD_DEVIATION 73.41 • n=4 Participants
|
|
Time since first metastasis
|
79.2 Months
STANDARD_DEVIATION 46.44 • n=5 Participants
|
86.8 Months
STANDARD_DEVIATION 78.07 • n=7 Participants
|
96.1 Months
STANDARD_DEVIATION 84.80 • n=5 Participants
|
88.8 Months
STANDARD_DEVIATION 73.41 • n=4 Participants
|
|
Time since disease progression
|
34.7 Months
STANDARD_DEVIATION 33.02 • n=5 Participants
|
1.2 Months
STANDARD_DEVIATION 1.55 • n=7 Participants
|
0.8 Months
STANDARD_DEVIATION 0.65 • n=5 Participants
|
5.8 Months
STANDARD_DEVIATION 16.01 • n=4 Participants
|
|
Number of patients by castration type
Surgery
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Number of patients by castration type
Pharmacological
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Number of patients by castration type
Not Applicable
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Number of patients by Primary and Secondary Gleason score
Primary Gleason score=3 &Secondary Gleason score=3
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Number of patients by Primary and Secondary Gleason score
Primary Gleason score=3 &Secondary Gleason score=4
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Number of patients by Primary and Secondary Gleason score
Primary Gleason score=4 &Secondary Gleason score=3
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Number of patients by Primary and Secondary Gleason score
Primary Gleason score=4 &Secondary Gleason score=4
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Number of patients by Primary and Secondary Gleason score
Primary Gleason score=4 &Secondary Gleason score=5
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Number of patients by Total Gleason score (>=6)
6
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Number of patients by Total Gleason score (>=6)
7
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Number of patients by Total Gleason score (>=6)
8
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Number of patients by Total Gleason score (>=6)
9
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Number of patients by Total Gleason score (>=6)
10
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Weight
|
91.48 kilogram (kg)
STANDARD_DEVIATION 18.091 • n=5 Participants
|
87.03 kilogram (kg)
STANDARD_DEVIATION 18.838 • n=7 Participants
|
93.20 kilogram (kg)
STANDARD_DEVIATION 11.402 • n=5 Participants
|
90.29 kilogram (kg)
STANDARD_DEVIATION 15.890 • n=4 Participants
|
|
Baseline Height
|
183.00 centimeter (cm)
STANDARD_DEVIATION 5.030 • n=5 Participants
|
177.96 centimeter (cm)
STANDARD_DEVIATION 6.596 • n=7 Participants
|
177.03 centimeter (cm)
STANDARD_DEVIATION 5.927 • n=5 Participants
|
178.65 centimeter (cm)
STANDARD_DEVIATION 6.281 • n=4 Participants
|
PRIMARY outcome
Timeframe: dosing through 28 days post-dosePopulation: Full Analysis Set (FAS)
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Serious TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Deaths Due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Treatment-Emergent Adverse Events (TEAEs)
|
1 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)Population: Full Analysis Set (FAS). Only participants with a value at each post-injection timepoints were included in the analysis.
PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for various organs (Brain, Heart Wall, Kidney, Lacrimal Gland, Liver, Lungs, Salivary Gland, Spleen and Thyroid) were produced as decay-corrected tissue of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Brain@2 hours post-injection
|
0.001310 mSv/MBq
Standard Deviation 0.0005902
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Brain@3-4 hours post-injection
|
0.001279 mSv/MBq
Standard Deviation 0.0007786
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Heart Wall@20-30 minutes post-injection
|
0.009010 mSv/MBq
Standard Deviation 0.0014472
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Heart Wall@3-4 hours post-injection
|
0.003209 mSv/MBq
Standard Deviation 0.0014961
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lacrimal Gland@20-30 minutes post-injection
|
0.000016 mSv/MBq
Standard Deviation 0.0000023
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lacrimal Gland@1 hour post-injection
|
0.000016 mSv/MBq
Standard Deviation 0.0000051
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lacrimal Gland@3-4 hours post-injection
|
0.000014 mSv/MBq
Standard Deviation 0.0000074
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lungs@2 hours post-injection
|
0.005023 mSv/MBq
Standard Deviation 0.0015987
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Salivary Gland@20-30 minutes post-injection
|
0.002001 mSv/MBq
Standard Deviation 0.0004118
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Salivary Gland@2 hours post-injection
|
0.001282 mSv/MBq
Standard Deviation 0.0006661
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Salivary Gland@3-4 hours post-injection
|
0.001032 mSv/MBq
Standard Deviation 0.0005455
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Spleen@1 hour post-injection
|
0.002645 mSv/MBq
Standard Deviation 0.0008966
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Spleen@2 hours post-injection
|
0.001724 mSv/MBq
Standard Deviation 0.0007601
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Thyroid@2 hours post-injection
|
0.000201 mSv/MBq
Standard Deviation NA
Only one participant analyzed
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Thyroid@3-4 hours post-injection
|
0.000128 mSv/MBq
Standard Deviation NA
Only one participant analyzed
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Brain@20-30 minutes post-injection
|
0.002196 mSv/MBq
Standard Deviation 0.0009359
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Brain@1 hour post-injection
|
0.001913 mSv/MBq
Standard Deviation 0.0003011
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Heart Wall@1 hour post-injection
|
0.006371 mSv/MBq
Standard Deviation 0.0012260
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Heart Wall@2 hours post-injection
|
0.004330 mSv/MBq
Standard Deviation 0.0014781
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Kidney@20-30 minutes post-injection
|
0.033219 mSv/MBq
Standard Deviation 0.0140235
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Kidney@1 hour post-injection
|
0.022069 mSv/MBq
Standard Deviation 0.0090106
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Kidney@2 hours post-injection
|
0.018424 mSv/MBq
Standard Deviation 0.0068331
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Kidney@3-4 hours post-injection
|
0.015772 mSv/MBq
Standard Deviation 0.0069341
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lacrimal Gland@2 hours post-injection
|
0.000015 mSv/MBq
Standard Deviation 0.0000045
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Liver@20-30 minutes post-injection
|
0.040546 mSv/MBq
Standard Deviation 0.0098781
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Liver@1 hour post-injection
|
0.030958 mSv/MBq
Standard Deviation 0.0073605
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Liver@2 hours post-injection
|
0.023145 mSv/MBq
Standard Deviation 0.0083627
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Liver@3-4 hours post-injection
|
0.018128 mSv/MBq
Standard Deviation 0.0081345
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lungs@20-30 minutes post-injection
|
0.010066 mSv/MBq
Standard Deviation 0.0017280
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lungs@1 hour post-injection
|
0.007535 mSv/MBq
Standard Deviation 0.0013048
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lungs@3-4 hours post-injection
|
0.003601 mSv/MBq
Standard Deviation 0.0016623
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Salivary Gland@1 hour post-injection
|
0.001585 mSv/MBq
Standard Deviation 0.0004877
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Spleen@20-30 minutes post-injection
|
0.003712 mSv/MBq
Standard Deviation 0.0010597
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Spleen@3-4 hours post-injection
|
0.001264 mSv/MBq
Standard Deviation 0.0006056
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Thyroid@20-30 minutes post-injection
|
0.000378 mSv/MBq
Standard Deviation NA
Only one participant analyzed
|
—
|
—
|
|
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Thyroid@1 hour post-injection
|
0.000266 mSv/MBq
Standard Deviation NA
Only one participant analyzed
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 6 hours post-dosePopulation: Full Analysis Set (FAS).
Urine samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The apparent systemic clearance for the analyte in urine (Cl) was summarized with descriptive statistics.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Phase I: Urinary Excretion of [68Ga]-PSMA-R2
|
5870 mL/hr
Standard Deviation 1820
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 6 hours post-dosePopulation: Full Analysis Set (FAS).
Serial blood samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The half-life (T\^1/2) for the analyte in blood was summarized with descriptive statistics.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Phase I: Half-life of 68Ga-PSMA-R2 in Blood
|
2.83 Hour
Standard Deviation 0.868
|
—
|
—
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)Population: Full Analysis Set (FAS). Only participants with a value at each post-injection timepoints were included in the analysis.
PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for the various organs were produced as non-decay-corrected fraction of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Heart Wall@1 hour post-injection
|
0.003484 mSv/MBq
Standard Deviation 0.0004766
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Kidney@2 hours post-injection
|
0.005825 mSv/MBq
Standard Deviation 0.0015596
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Kidney@3-4 hours post-injection
|
0.002766 mSv/MBq
Standard Deviation 0.0006581
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lungs@2 hours post-injection
|
0.001573 mSv/MBq
Standard Deviation 0.0002652
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Spleen@1 hour post-injection
|
0.001444 mSv/MBq
Standard Deviation 0.0004213
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Spleen@2 hours post-injection
|
0.000536 mSv/MBq
Standard Deviation 0.0001640
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Spleen@3-4 hours post-injection
|
0.000217 mSv/MBq
Standard Deviation 0.0000567
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Thyroid@20-30 minutes post-injection
|
0.000289 mSv/MBq
Standard Deviation NA
Only one participant analyzed
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Brain@20-30 minutes post-injection
|
0.001686 mSv/MBq
Standard Deviation 0.0007242
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Brain@1 hour post-injection
|
0.001046 mSv/MBq
Standard Deviation 0.0000814
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Brain@2 hours post-injection
|
0.000423 mSv/MBq
Standard Deviation 0.0001630
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Brain@3-4 hours post-injection
|
0.000222 mSv/MBq
Standard Deviation 0.0000924
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Heart Wall@20-30 minutes post-injection
|
0.006914 mSv/MBq
Standard Deviation 0.0011156
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Heart Wall@2 hours post-injection
|
0.001332 mSv/MBq
Standard Deviation 0.0002056
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Heart Wall@3-4 hours post-injection
|
0.000542 mSv/MBq
Standard Deviation 0.0001255
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Kidney@20-30 minutes post-injection
|
0.025506 mSv/MBq
Standard Deviation 0.0107777
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Kidney@1 hour post-injection
|
0.012059 mSv/MBq
Standard Deviation 0.0043426
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lacrimal Gland@20-30 minutes post-injection
|
0.000012 mSv/MBq
Standard Deviation 0.0000019
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lacrimal Gland@1 hour post-injection
|
0.000009 mSv/MBq
Standard Deviation 0.0000022
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lacrimal Gland@2 hours post-injection
|
0.000005 mSv/MBq
Standard Deviation 0.0000011
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lacrimal Gland@3-4 hours post-injection
|
0.000002 mSv/MBq
Standard Deviation 0.0000008
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Liver@20-30 minutes post-injection
|
0.031128 mSv/MBq
Standard Deviation 0.0076342
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Liver@1 hour post-injection
|
0.016949 mSv/MBq
Standard Deviation 0.0032692
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Liver@2 hours post-injection
|
0.007172 mSv/MBq
Standard Deviation 0.0014994
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Liver@3-4 hours post-injection
|
0.003087 mSv/MBq
Standard Deviation 0.0006828
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lungs@20-30 minutes post-injection
|
0.007729 mSv/MBq
Standard Deviation 0.0013599
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lungs@1 hour post-injection
|
0.004149 mSv/MBq
Standard Deviation 0.0006660
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Lungs@3-4 hours post-injection
|
0.000631 mSv/MBq
Standard Deviation 0.0001601
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Salivary Gland@20-30 minutes post-injection
|
0.001536 mSv/MBq
Standard Deviation 0.0003192
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Salivary Gland@1 hour post-injection
|
0.000859 mSv/MBq
Standard Deviation 0.0002093
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Salivary Gland@2 hours post-injection
|
0.000386 mSv/MBq
Standard Deviation 0.0001469
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Salivary Gland@3-4 hours post-injection
|
0.000173 mSv/MBq
Standard Deviation 0.0000550
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Spleen@20-30 minutes post-injection
|
0.002849 mSv/MBq
Standard Deviation 0.0008140
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Thyroid@1 hour post-injection
|
0.000136 mSv/MBq
Standard Deviation NA
Only one participant analyzed
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Thyroid@2 hours post-injection
|
0.000057 mSv/MBq
Standard Deviation NA
Only one participant analyzed
|
—
|
—
|
|
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
Thyroid@3-4 hours post-injection
|
0.000020 mSv/MBq
Standard Deviation NA
Only one participant analyzed
|
—
|
—
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1Population: Full Analysis Set (FAS). For each parameter, only participants with a value are included in the analysis.
Residence times of radiation in normal organs were summarized with descriptive statistics.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Phase I: Residence Times in Normal Organs
Brain
|
0.002895 MBq-hr/MBq
Standard Deviation 0.0009849
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Heart
|
0.010459 MBq-hr/MBq
Standard Deviation 0.0014152
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Kidney
|
0.039360 MBq-hr/MBq
Standard Deviation 0.0133500
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Lungs
|
0.012084 MBq-hr/MBq
Standard Deviation 0.0019321
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Salivary Gland
|
0.002594 MBq-hr/MBq
Standard Deviation 0.0006622
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Spleen
|
0.004291 MBq-hr/MBq
Standard Deviation 0.0012416
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Lacrimal Gland
|
0.000027 MBq-hr/MBq
Standard Deviation 0.0000052
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Liver
|
0.050735 MBq-hr/MBq
Standard Deviation 0.0103951
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Thyroid
|
0.000424 MBq-hr/MBq
Standard Deviation NA
Only one participant analyzed
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Urinary Bladder
|
0.092947 MBq-hr/MBq
Standard Deviation 0.0453608
|
—
|
—
|
|
Phase I: Residence Times in Normal Organs
Remainder
|
1.417135 MBq-hr/MBq
Standard Deviation 0.0582923
|
—
|
—
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1Population: Full Analysis Set (FAS).
Absorbed radiation dose of 68Ga-PSMA-R2 in target organs were summarized with descriptive statistics.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Brain
|
0.002563 mGy/MBq
Standard Deviation 0.000336
|
—
|
—
|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Heart
|
0.018417 mGy/MBq
Standard Deviation 0.0020094
|
—
|
—
|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Kidney
|
0.060683 mGy/MBq
Standard Deviation 0.0190588
|
—
|
—
|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Lacrimal Gland
|
0.008065 mGy/MBq
Standard Deviation 0.0015741
|
—
|
—
|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Liver
|
0.017417 mGy/MBq
Standard Deviation 0.0029976
|
—
|
—
|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Lungs
|
0.007967 mGy/MBq
Standard Deviation 0.0007718
|
—
|
—
|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Red Marrow
|
0.010700 mGy/MBq
Standard Deviation 0.0002280
|
—
|
—
|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Salivary Gland
|
0.015600 mGy/MBq
Standard Deviation 0.0032012
|
—
|
—
|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Spleen
|
0.017333 mGy/MBq
Standard Deviation 0.0037109
|
—
|
—
|
|
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Urinary Bladder
|
0.120317 mGy/MBq
Standard Deviation 0.0517023
|
—
|
—
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1Population: Full Analysis Set (FAS)
The whole-body dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Phase I: Whole-body Dose of 68Ga-PSMA-R2
|
0.013800 mGy/MBq
Standard Deviation 0.0000632
|
—
|
—
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1Population: Full Analysis Set (FAS)
The effective dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Phase I: Effective Dose of 68Ga-PSMA-R2
|
0.014583 mSv/MBq
Standard Deviation 0.0019343
|
—
|
—
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)Population: Full Analysis Set (FAS)
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint
PET (1hr): SUVmax (lesion)
|
4.493 Standard Uptake Value (SUV)
Standard Deviation 1.4060
|
4.421 Standard Uptake Value (SUV)
Standard Deviation 1.4512
|
6.725 Standard Uptake Value (SUV)
Standard Deviation 5.5327
|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint
PET (1hr): SUVmean (background)
|
0.980 Standard Uptake Value (SUV)
Standard Deviation 0.0283
|
0.643 Standard Uptake Value (SUV)
Standard Deviation 0.2318
|
0.750 Standard Uptake Value (SUV)
Standard Deviation 0.3002
|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint
PET (2hr): SUVmax (lesion)
|
3.767 Standard Uptake Value (SUV)
Standard Deviation 1.1493
|
5.098 Standard Uptake Value (SUV)
Standard Deviation 1.8597
|
6.846 Standard Uptake Value (SUV)
Standard Deviation 4.7745
|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint
PET (2hr): SUVmean (background)
|
0.630 Standard Uptake Value (SUV)
Standard Deviation 0.3145
|
0.651 Standard Uptake Value (SUV)
Standard Deviation 0.2817
|
0.550 Standard Uptake Value (SUV)
Standard Deviation 0.1948
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)Population: Full Analysis Set (FAS)
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint
PET (1hr): TBR
|
4.520 Ratio
Standard Deviation 1.3558
|
7.464 Ratio
Standard Deviation 3.0364
|
11.141 Ratio
Standard Deviation 10.6283
|
|
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint
PET (2hr): TBR
|
5.694 Ratio
Standard Deviation 1.7104
|
7.780 Ratio
Standard Deviation 3.6034
|
12.588 Ratio
Standard Deviation 9.1146
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)Population: Full Analysis Set (FAS). Only participants with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET included in the analysis.
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
PET (2hr): SUVmax (lesion)
|
—
|
—
|
7.647 Standard Uptake Value (SUV)
Standard Deviation 5.3409
|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
PET (2hr): SUVmean (background)
|
—
|
—
|
0.541 Standard Uptake Value (SUV)
Standard Deviation 0.2234
|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
PET (1hr): SUVmax (lesion)
|
—
|
—
|
7.087 Standard Uptake Value (SUV)
Standard Deviation 4.9133
|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
PET (1hr): SUVmean (background)
|
—
|
—
|
0.689 Standard Uptake Value (SUV)
Standard Deviation 0.1955
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)Population: Full Analysis Set (FAS). Only participants with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET included in the analysis.
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
PET (1hr): TBR
|
—
|
—
|
11.573 Ratio
Standard Deviation 10.2632
|
|
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
PET (2hr): TBR
|
—
|
—
|
14.880 Ratio
Standard Deviation 10.1991
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)Population: Full Analysis Set (FAS)
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
PET (1hr): SUVmax (lesion)
|
4.493 Standard Uptake Value (SUV)
Standard Deviation 1.4060
|
4.421 Standard Uptake Value (SUV)
Standard Deviation 1.4512
|
6.578 Standard Uptake Value (SUV)
Standard Deviation 5.8224
|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
PET (2hr): SUVmax (lesion)
|
3.767 Standard Uptake Value (SUV)
Standard Deviation 1.1493
|
5.098 Standard Uptake Value (SUV)
Standard Deviation 1.8597
|
6.566 Standard Uptake Value (SUV)
Standard Deviation 4.5956
|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
PET (1hr): SUVmean (background)
|
0.980 Standard Uptake Value (SUV)
Standard Deviation 0.0283
|
0.643 Standard Uptake Value (SUV)
Standard Deviation 0.2318
|
0.723 Standard Uptake Value (SUV)
Standard Deviation 0.3020
|
|
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
PET (2hr): SUVmean (background)
|
0.630 Standard Uptake Value (SUV)
Standard Deviation 0.3145
|
0.651 Standard Uptake Value (SUV)
Standard Deviation 0.2817
|
0.581 Standard Uptake Value (SUV)
Standard Deviation 0.2119
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)Population: Full Analysis Set (FAS)
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
PET (2hr): TBR
|
5.694 Ratio
Standard Deviation 1.7104
|
7.780 Ratio
Standard Deviation 3.6034
|
11.788 Ratio
Standard Deviation 8.6914
|
|
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
PET (1hr): TBR
|
4.520 Ratio
Standard Deviation 1.3558
|
7.464 Ratio
Standard Deviation 3.0364
|
10.965 Ratio
Standard Deviation 10.9067
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)Population: Full Analysis Set (FAS)
The subject-level positive percent agreement, negative percent agreement, and overall percent agreement was calculated based on the number of subjects with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan. These percent agreements were calculated as follows: * Positive percent agreement: a/(a+c) × 100 * Negative percent agreement: d/(b+d) × 100 * Overall percent agreement: (a+d)/(a+b+c+d) × 100 Where: * a = number of subjects with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET scan * b = number of subjects with at least 1 positive lesion detected by PET scan that was not correlated with conventional scan * c = number of subjects with at least 1 positive lesion detected by conventional scan that was not correlated with PET scan * d = number of subjects with no lesions detected by conventional scan or PET scan.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients
PET(1hr): Positive percent agreement
|
0.0 Percent Agreement
Not calculated, 0 participants with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan
|
0.0 Percent Agreement
Not calculated, 0 participants with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan
|
87.5 Percent Agreement
Interval 47.35 to 99.68
|
|
Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients
PET(1hr): Negative percent agreement
|
66.7 Percent Agreement
Interval 22.28 to 95.67
|
25.0 Percent Agreement
Interval 5.49 to 57.19
|
0.0 Percent Agreement
Interval 0.0 to 60.24
|
|
Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients
PET(1hr): Overall percent agreement
|
66.7 Percent Agreement
Interval 22.28 to 95.67
|
25.0 Percent Agreement
Interval 5.49 to 57.19
|
58.3 Percent Agreement
Interval 27.67 to 84.83
|
|
Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients
PET(2hr): Positive percent agreement
|
0.0 Percent Agreement
Not calculated, 0 participants with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan
|
0.0 Percent Agreement
Not calculated, 0 participants with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan
|
87.5 Percent Agreement
Interval 47.35 to 99.68
|
|
Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients
PET(2hr): Negative percent agreement
|
33.3 Percent Agreement
Interval 4.33 to 77.72
|
25.0 Percent Agreement
Interval 5.49 to 57.19
|
50.0 Percent Agreement
Interval 6.76 to 93.24
|
|
Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients
PET(2hr): Overall percent agreement
|
33.3 Percent Agreement
Interval 4.33 to 77.72
|
5.49 Percent Agreement
Interval 5.49 to 57.19
|
75.0 Percent Agreement
Interval 42.81 to 94.51
|
SECONDARY outcome
Timeframe: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour post-injection)Population: Full Analysis Set (FAS)
The differences of number of positive lesions, number of positive lesions detected by PET scan and/or conventional scan and the location of positive lesions were summarized with descriptive statistics.
Outcome measures
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=30 Participants
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Lymph Node,Retroperitoneal
|
2 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Lymph Node,Supraclavicular,L
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Other,Extranodal
|
3 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Other,Nodal
|
3 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Pelvic Bone
|
6 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Rib(s),L.
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Rib(s),R.
|
2 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Urethra
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
Conventional (+) and not detected by PET scan
|
7 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
CT+/undetected by PET:Bone,Lumbar Spine
|
2 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
CT+/undetected by PET:Bone,Other
|
2 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
CT+/undetected by PET:Bone,Thoracic Spine
|
5 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
CT+/undetected by PET:Lymph Node,Pelvic
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
CT+/undetected by PET:Pelvic Bone
|
6 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
CT+/undetected by PET:Rib(s),L.
|
2 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
CT+/undetected by PET:Rib(s),R.
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
CT+/undetected by PET:Skull
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET (positive)
|
22 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
Conventional (postive)
|
8 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
Difference = PET(+) - Conventional(+)
|
14 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET(+) and detected by conventional scan
|
7 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/detected by CT:Bone,Cervical Spine
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/detected by CT:Bone,Lumbar Spine
|
3 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/detected by CT:Bone,Thoracic Spine
|
3 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/detected by CT:Pelvic Bone
|
2 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/detected by CT:Pelvis
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/detected by CT:Rib(s),L.
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/detected by CT:Rib(s),R.
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET(+) and not detected by conventional scan
|
21 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Abdominal Wall
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Bone,Lumbar Spine
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Bone,Other
|
5 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Bone,Thoracic Spine
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Lymph Node,Common Iliac
|
9 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Lymph Node,External
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Lymph Node,Inguinal,L.
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Lymph Node,Inguinal,R.
|
1 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Lymph Node,Para-Aortic
|
6 Positive Lesion
|
—
|
—
|
|
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
PET+/undetected by CT:Lymph Node,Retrocrural
|
1 Positive Lesion
|
—
|
—
|
Adverse Events
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Metastatic Prostate Cancer (mPCa) (Phase II)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 participants at risk
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 participants at risk
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 participants at risk
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
0.00%
0/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
Other adverse events
| Measure |
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)
n=6 participants at risk
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)
n=12 participants at risk
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
Metastatic Prostate Cancer (mPCa) (Phase II)
n=12 participants at risk
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
16.7%
2/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
0.00%
0/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
0.00%
0/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
0.00%
0/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
0.00%
0/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.7%
1/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
0.00%
0/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
0.00%
0/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
0.00%
0/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
0.00%
0/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
8.3%
1/12 • Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER