Trial Outcomes & Findings for 68 Ga-PSMA for High Risk Prostate Cancer (NCT NCT04614363)
NCT ID: NCT04614363
Last Updated: 2023-08-28
Results Overview
Number of patients with cTxNoMo (clinically localized disease) found on final histological examination to have lymph node involvement as determined by 68GA-PSMA-11 PET/CT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
80 participants
Primary outcome timeframe
18 months
Results posted on
2023-08-28
Participant Flow
Participant milestones
| Measure |
Localized High Risk Prostate Cancer
Patients with high risk prostate cancer scheduled for prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
Biochemical Recurrence
Patients with biochemical recurrence post radical prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
50
|
|
Overall Study
COMPLETED
|
27
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
68 Ga-PSMA for High Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Localized High Risk Prostate Cancer
n=30 Participants
Patients with high risk prostate cancer scheduled for prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
Biochemical Recurrence
n=50 Participants
Patients with biochemical recurrence post radical prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
50 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsNumber of patients with cTxNoMo (clinically localized disease) found on final histological examination to have lymph node involvement as determined by 68GA-PSMA-11 PET/CT.
Outcome measures
| Measure |
Localized High Risk Prostate Cancer
n=30 Participants
Patients with high risk prostate cancer scheduled for prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
Biochemical Recurrence
n=50 Participants
Patients with biochemical recurrence post radical prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
|---|---|---|
|
Proportion of Patients With Lymph Node Involvement
|
4 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: 18 monthsNumber of patients in which 68GA-PSMA-11 PET/CT altered the planned clinical management.
Outcome measures
| Measure |
Localized High Risk Prostate Cancer
n=30 Participants
Patients with high risk prostate cancer scheduled for prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
Biochemical Recurrence
n=50 Participants
Patients with biochemical recurrence post radical prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
|---|---|---|
|
Proportion of Patients Which Clinical Management Was Altered
|
2 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 18 monthsUptake intensity detected on PET/CT in the prostate and outside of the prostate
Outcome measures
| Measure |
Localized High Risk Prostate Cancer
n=30 Participants
Patients with high risk prostate cancer scheduled for prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
Biochemical Recurrence
n=50 Participants
Patients with biochemical recurrence post radical prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
|---|---|---|
|
Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness
SUV (mean) inside the prostate : mean SUV
|
22.45 SUV
Interval 3.9 to 105.7
|
0 SUV
Interval 0.0 to 0.0
|
|
Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness
SUV (mean) outside the prostate
|
43.8 SUV
Interval 12.8 to 74.9
|
16.9 SUV
Interval 2.1 to 99.7
|
SECONDARY outcome
Timeframe: 18 monthsNumber of patients in which 68Ga-PSMA 11 PET/CT showed suspicious lesions that are were not seen in standard diagnostic modalities of bone scan, CTs or MRI.
Outcome measures
| Measure |
Localized High Risk Prostate Cancer
n=30 Participants
Patients with high risk prostate cancer scheduled for prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
Biochemical Recurrence
n=50 Participants
Patients with biochemical recurrence post radical prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection.
|
|---|---|---|
|
Number of Patients With Suspicious Lesions
|
4 Participants
|
17 Participants
|
Adverse Events
Localized High Risk Prostate Cancer
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Biochemical Recurrence
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Localized High Risk Prostate Cancer
n=30 participants at risk
One patient was hospitalized due to acute CVA, grade 2, not related.
|
Biochemical Recurrence
n=50 participants at risk
Two patients in this group died. These events were not related to the study. Acute encephalopathy and metastatic prostate cancer to liver, bone and brain.
|
|---|---|---|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/30 • Participants were followed at 2 and 6 months post PET scan.
|
2.0%
1/50 • Number of events 1 • Participants were followed at 2 and 6 months post PET scan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastasis
|
0.00%
0/30 • Participants were followed at 2 and 6 months post PET scan.
|
2.0%
1/50 • Number of events 1 • Participants were followed at 2 and 6 months post PET scan.
|
|
Nervous system disorders
Acute cerebrovascular accident
|
3.3%
1/30 • Number of events 1 • Participants were followed at 2 and 6 months post PET scan.
|
0.00%
0/50 • Participants were followed at 2 and 6 months post PET scan.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place