Trial Outcomes & Findings for 64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA) (NCT NCT05249127)
NCT ID: NCT05249127
Last Updated: 2024-10-01
Results Overview
Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
up to 7 days post injection
Results posted on
2024-10-01
Participant Flow
Dates of recruitment period: 11 Apr 2022 to 23 Jan 2023
Participant milestones
| Measure |
64Cu-SAR-bisPSMA Injection
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
64Cu-SAR-bisPSMA Injection
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|
|
Overall Study
Protocol Violation
|
13
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Participant Non-compliance
|
1
|
Baseline Characteristics
64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)
Baseline characteristics by cohort
| Measure |
64Cu-SAR-bisPSMA Injection
n=52 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
|
Baseline PSA
|
2.973 ng/mL
STANDARD_DEVIATION 4.1722 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 7 days post injectionPopulation: All Participants who received any amount of 64Cu-SAR-bisPSMA.
Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=52 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Safety and Tolerability
Any TEAE
|
10 Participants
|
—
|
|
Safety and Tolerability
TEAE Grade 1 to 2
|
8 Participants
|
—
|
|
Safety and Tolerability
TEAE Grade 3
|
2 Participants
|
—
|
|
Safety and Tolerability
TEAE Grade 4 to 5
|
0 Participants
|
—
|
|
Safety and Tolerability
TEAE Related to 64Cu-SAR-bisPSMA
|
1 Participants
|
—
|
|
Safety and Tolerability
Serious TEAE
|
1 Participants
|
—
|
|
Safety and Tolerability
Serious TEAE related to Cu64-SAR-bisPSMA
|
0 Participants
|
—
|
|
Safety and Tolerability
TEAE leading to withdrawal from study
|
0 Participants
|
—
|
|
Safety and Tolerability
TEAE with fatal outcome
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 (1- 4 hours) post injectionPopulation: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint (participant-level or region-level).
The percentage of TP participants on the Day 0 scan out of all participants with a Day 0 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=42 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Participant-level Correct Detection Rate (CDR)- Day 0
Reader 1
|
26.2 percentage of TP participants
Interval 13.9 to 42.0
|
—
|
|
Participant-level Correct Detection Rate (CDR)- Day 0
Reader 2
|
23.8 percentage of TP participants
Interval 12.1 to 39.5
|
—
|
|
Participant-level Correct Detection Rate (CDR)- Day 0
Reader 3
|
19.0 percentage of TP participants
Interval 8.6 to 34.1
|
—
|
PRIMARY outcome
Timeframe: Day 1 (24+/-6 Hours) post injectionPopulation: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint.
The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=42 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Participant-level CDR- Day 1
Reader 1
|
33.3 percentage of TP participants
Interval 19.6 to 49.5
|
—
|
|
Participant-level CDR- Day 1
Reader 2
|
33.3 percentage of TP participants
Interval 19.6 to 49.5
|
—
|
|
Participant-level CDR- Day 1
Reader 3
|
26.2 percentage of TP participants
Interval 13.9 to 42.0
|
—
|
PRIMARY outcome
Timeframe: Day 0 (1- 4 hours)Population: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint (participant-level or region-level).
The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=195 Regions
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Region-level Positive Predictive Value (PPV)- Day 0
Reader 1
|
41.2 percentage of TP regions
Interval 24.6 to 59.3
|
—
|
|
Region-level Positive Predictive Value (PPV)- Day 0
Reader 2
|
44.8 percentage of TP regions
Interval 26.4 to 64.3
|
—
|
|
Region-level Positive Predictive Value (PPV)- Day 0
Reader 3
|
39.1 percentage of TP regions
Interval 19.7 to 61.5
|
—
|
PRIMARY outcome
Timeframe: Day 1 (24 +/- 6 hours)Population: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint (participant-level or region-level).
The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=195 Regions
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Region-level PPV- Day 1
Reader 1
|
41.5 percentage of TP regions
Interval 26.3 to 57.9
|
—
|
|
Region-level PPV- Day 1
Reader 2
|
32.7 percentage of TP regions
Interval 20.3 to 47.1
|
—
|
|
Region-level PPV- Day 1
Reader 3
|
43.3 percentage of TP regions
Interval 25.5 to 62.6
|
—
|
SECONDARY outcome
Timeframe: Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injectionPopulation: All enrolled participants who received any amount of 64Cu-SAR-bisPSMA who had at least one biodistribution measure. The number of participants analyzed varied depending on the number of lesions identified by each reader in each participant and in each region.
The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue and bone.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=50 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
n=50 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Reader 1 All Lesions
|
9.898 g/mL
Standard Deviation 5.9588
|
15.818 g/mL
Standard Deviation 15.0800
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Reader 2 All Lesions
|
8.990 g/mL
Standard Deviation 5.8339
|
14.678 g/mL
Standard Deviation 19.4486
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Reader 3 All Lesions
|
6.635 g/mL
Standard Deviation 3.2447
|
14.729 g/mL
Standard Deviation 11.1719
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Reader 1 Bone Lesions
|
9.188 g/mL
Standard Deviation 4.7099
|
17.699 g/mL
Standard Deviation 10.7888
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Reader 2 Bone Lesions
|
8.611 g/mL
Standard Deviation 4.2796
|
10.503 g/mL
Standard Deviation 11.9074
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Reader 3 Bone Lesions
|
7.283 g/mL
Standard Deviation 4.4456
|
19.408 g/mL
Standard Deviation 10.9045
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Reader 1 Soft Tissue Lesions
|
9.706 g/mL
Standard Deviation 6.2907
|
15.56 g/mL
Standard Deviation 15.5137
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Reader 2 Soft Tissue Lesions
|
9.018 g/mL
Standard Deviation 6.1432
|
15.402 g/mL
Standard Deviation 20.2457
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Reader 3 Soft Tissue Lesions
|
6.386 g/mL
Standard Deviation 3.2565
|
14.093 g/mL
Standard Deviation 11.4177
|
SECONDARY outcome
Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)Population: All enrolled participants who received any amount of 64Cu-SAR-bisPSMA who had at least one biodistribution measure. The number of participants analyzed varied depending on the number of lesions identified by each reader in each participant and in each region.
SUVmax in lesions, visceral soft tissue and bone
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=50 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
n=50 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Reader 1 All Lesions
|
13.973 g/mL
Standard Deviation 8.9671
|
22.198 g/mL
Standard Deviation 18.6239
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Reader 2 All Lesions
|
13.914 g/mL
Standard Deviation 10.3342
|
22.789 g/mL
Standard Deviation 32.3980
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Reader 3 All Lesions
|
13.924 g/mL
Standard Deviation 7.6483
|
33.363 g/mL
Standard Deviation 37.7745
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Reader 1 Bone Lesions
|
13.05 g/mL
Standard Deviation 6.4444
|
27.600 g/mL
Standard Deviation 17.7468
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Reader 2 Bone Lesions
|
14.156 g/mL
Standard Deviation 6.0519
|
16.660 g/mL
Standard Deviation 17.9690
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Reader 3 Bone Lesions
|
16.718 g/mL
Standard Deviation 5.0380
|
37.223 g/mL
Standard Deviation 19.9721
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Reader 1 Soft Tissue Lesions
|
13.746 g/mL
Standard Deviation 9.5714
|
21.832 g/mL
Standard Deviation 19.2837
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Reader 2 Soft Tissue Lesions
|
13.680 g/mL
Standard Deviation 11.1150
|
24.068 g/mL
Standard Deviation 33.7881
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Reader 3 Soft Tissue Lesions
|
12.981 g/mL
Standard Deviation 8.1606
|
32.976 g/mL
Standard Deviation 39.5467
|
SECONDARY outcome
Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)Population: All enrolled participants who received any amount of 64Cu-SAR-bisPSMA who had at least one biodistribution measure. The number of participants analyzed varied depending on the number of lesions identified by each reader in each participant and in each region.
Lesion to Background ratio. SUVmax of the lesion divided by the SUVmean of gluteus background
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=50 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
n=50 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVr
Reader 1 All Lesions
|
23.233 ratio
Standard Deviation 14.0537
|
118.051 ratio
Standard Deviation 90.7403
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVr
Reader 2 All Lesions
|
23.476 ratio
Standard Deviation 17.3919
|
121.306 ratio
Standard Deviation 160.9991
|
|
Biodistribution of 64Cu-SAR-bisPSMA- SUVr
Reader 3 All Lesions
|
25.448 ratio
Standard Deviation 15.0785
|
181.673 ratio
Standard Deviation 171.6481
|
SECONDARY outcome
Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)Population: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint (participant-level or region-level).
Percentage of TP participants on the Day 0 or Day 1 scan out of all participants with a positive Day 0 or Day 1 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=42 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
n=42 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Participant-level PPV
Reader 1
|
44.0 percentage of TP participants
Interval 24.4 to 65.1
|
45.2 percentage of TP participants
Interval 27.3 to 64.0
|
|
Participant-level PPV
Rader 2
|
43.5 percentage of TP participants
Interval 23.2 to 65.5
|
40.0 percentage of TP participants
Interval 23.9 to 57.9
|
|
Participant-level PPV
Reader 3
|
42.1 percentage of TP participants
Interval 20.3 to 66.5
|
47.8 percentage of TP participants
Interval 26.8 to 69.4
|
SECONDARY outcome
Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)Population: All participants who received any amount of 64Cu-SAR-bisPSMA, and had 64Cu-SAR-bisPSMA PET/CT imaging results from at least one central reader
Percentage of participants with a positive Day 0 or Day 1 scan out of all participants with a Day 0 or Day 1 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=50 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
n=50 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Participant-level Detection Rate (DR)
Reader 1
|
58.0 percentage of TP participants
Interval 43.2 to 71.8
|
74.0 percentage of TP participants
Interval 59.7 to 85.4
|
|
Participant-level Detection Rate (DR)
Reader 2
|
56.0 percentage of TP participants
Interval 41.3 to 70.0
|
80.0 percentage of TP participants
Interval 66.3 to 90.0
|
|
Participant-level Detection Rate (DR)
Reader 3
|
44.0 percentage of TP participants
Interval 30.0 to 58.7
|
58.0 percentage of TP participants
Interval 43.2 to 71.8
|
SECONDARY outcome
Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)Population: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint (participant-level or region-level).
Percentage of false positive (FP) participants on the Day 0 or Day 1 scan out of all participants with a positive Day 0 or Day 1 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=42 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
n=42 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Participant-level False Positive Rate (FPR)
Reader 1
|
53.8 percentage of FP participants
Interval 33.4 to 73.4
|
54.8 percentage of FP participants
Interval 36.0 to 72.7
|
|
Participant-level False Positive Rate (FPR)
Reader 2
|
54.2 percentage of FP participants
Interval 32.8 to 74.4
|
60.0 percentage of FP participants
Interval 42.1 to 76.1
|
|
Participant-level False Positive Rate (FPR)
Reader 3
|
57.9 percentage of FP participants
Interval 33.5 to 79.7
|
50.0 percentage of FP participants
Interval 29.1 to 70.9
|
SECONDARY outcome
Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)Population: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint (participant-level or region-level).
Percentage of FP regions on the Day 0 or Day 1 scan out of all positive regions on the Day 0 or Day 1 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=195 regions
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
n=195 regions
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Region-level FPR
Reader 1
|
58.8 percentage of FP regions
Interval 40.7 to 75.4
|
57.1 percentage of FP regions
Interval 41.0 to 72.3
|
|
Region-level FPR
Reader 2
|
55.2 percentage of FP regions
Interval 35.7 to 73.6
|
67.3 percentage of FP regions
Interval 52.9 to 79.7
|
|
Region-level FPR
Reader 3
|
60.9 percentage of FP regions
Interval 38.5 to 80.3
|
56.7 percentage of FP regions
Interval 37.4 to 74.5
|
SECONDARY outcome
Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)Population: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results from at least one central reader and had a positive reference standard on the participant level.
Percentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=14 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Participant-level Discrepant PET Negativity Rate
Reader 1
|
14.3 percentage of participants
Interval 1.8 to 42.8
|
—
|
|
Participant-level Discrepant PET Negativity Rate
Reader 2
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
—
|
|
Participant-level Discrepant PET Negativity Rate
Reader 3
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
—
|
SECONDARY outcome
Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)Population: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint (participant-level or region-level).
Percentage of TN participants on the Day 0 or Day 1 scan out of all participants with a negative Day 0 or Day 1 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=42 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
n=42 Participants
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Participant-level True Negative Rate (TNR)
Reader 1
|
50.0 percentage of TN participants
Interval 30.6 to 69.4
|
39.3 percentage of TN participants
Interval 21.5 to 59.4
|
|
Participant-level True Negative Rate (TNR)
Reader 2
|
53.6 percentage of TN participants
Interval 33.9 to 72.5
|
25.0 percentage of TN participants
Interval 10.7 to 44.9
|
|
Participant-level True Negative Rate (TNR)
Reader 3
|
60.7 percentage of TN participants
Interval 40.6 to 78.5
|
57.1 percentage of TN participants
Interval 37.2 to 91.8
|
SECONDARY outcome
Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)Population: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint (participant-level or region-level).
Percentage of TN regions on the Day 0 or Day 1 scan out of all negative regions on the Day 0 or Day 1 scan.
Outcome measures
| Measure |
64Cu-SAR-bisPSMA Injection
n=195 regions
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR-bisPSMA followed by a PET/CT scan Day 0 (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
SUVmean - Day 1
n=195 regions
Single Arm:
Participants with suspected recurrence of prostate cancer based on detectable or rising PSA following definitive therapy, who had negative or equivocal findings on institutional standard of care conventional imaging, received a single intravenous Injection of 64Cu-SAR- bisPSMA followed by a PET/CT scan Day O (1 to 4 hours post injection) and Day 1 (24 +/- 6 hours post injection).
|
|---|---|---|
|
Region-level TNR
Reader 1
|
88.7 percentage of TN regions
Interval 83.1 to 93.0
|
86.4 percentage of TN regions
Interval 80.5 to 91.1
|
|
Region-level TNR
Reader 2
|
91.0 percentage of TN regions
Interval 85.7 to 94.7
|
80.1 percentage of TN regions
Interval 73.4 to 85.7
|
|
Region-level TNR
Reader 3
|
92.1 percentage of TN regions
Interval 87.2 to 95.6
|
90.4 percentage of TN regions
Interval 85.1 to 94.3
|
Adverse Events
Safety Analysis Set
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Analysis Set
n=52 participants at risk
All participants enrolled who received any amount of 64Cu-SAR-bisPSMA.
|
|---|---|
|
Infections and infestations
urosepsis
|
1.9%
1/52 • Number of events 1 • Up to 7 days post injection
Physical exam pre-dose and at Day 7. Vital signs pre and post dose and at Day 7. Duplicate 12-lead ECG pre and 30 +/- 10 minutes post dose. Hematology, biochemistry, urinalysis and coagulation lab tests at screening and 7 days post dose. Adverse event monitoring pre and post dose, and up to Day 7.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Othon Gervasio, Chief Medical Officer
Clarity Pharmaceuticals
Phone: +61 2 9209 4037
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study results may only be published by the principal investigator / institution following the first multi-site publication. The proposed publication will be submitted to Sponsor at least 90 days prior to submission to the publication to allow the Sponsor to delete Sponsor Confidential Information (other than Study results), correct any inaccuracies or delay the publication to allow for filing of patent applications.
- Publication restrictions are in place
Restriction type: OTHER