Biochemical Recurrence of Malignant Neoplasm of Prostate
Conditions
Brief summary
The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.
Detailed description
Participants with biochemical evidence of recurrence of PC were evaluated with 64CU-SAR-bisPSMA PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later, eg. Histopathology/biopsy, conventional imaging, PSA reduction post focal salvage therapy or radiotherapy with no concomitant androgen deprivation therapy. Three independent central readers blinded to the participant number, the time of the PET/CT scan and the results of the conventional methodologies assessed the 64Cu-SAR-bisPSMA PET/CT. Three separate independent readers assessed the results of the conventional methodologies.
Interventions
DRUG64Cu-SAR-bisPSMA
64Cu-SAR-bisPSMA
Sponsors
Clarity Pharmaceuticals Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age. 2. Signed informed consent. 3. Life expectancy ≥ 12 weeks as determined by the Investigator. 4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy. 5. Suspected recurrence of prostate cancer (PC) based on rising Prostate-specific antigen (PSA) after definitive therapy on the basis of: 1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or 2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition). 6. Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day 0. 7. The Eastern Cooperative Oncology performance status 0-2. 8. Adequate recovery from acute toxic effects of any prior therapy. 9. Estimated Glomerular Filtration Rate of 30 mL/min or higher. 10. Adequate liver function. 11. For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.
Exclusion criteria
1. Participants who received other investigational agents within 28 days prior to Day 0. 2. Participants administered any high energy (\>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0. 3. Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC. 4. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. 5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | up to 7 days post injection | Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0 |
| Participant-level Correct Detection Rate (CDR)- Day 0 | Day 0 (1- 4 hours) post injection | The percentage of TP participants on the Day 0 scan out of all participants with a Day 0 scan. |
| Participant-level CDR- Day 1 | Day 1 (24+/-6 Hours) post injection | The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan. |
| Region-level Positive Predictive Value (PPV)- Day 0 | Day 0 (1- 4 hours) | The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan. |
| Region-level PPV- Day 1 | Day 1 (24 +/- 6 hours) | The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant-level False Positive Rate (FPR) | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | 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. |
| Region-level FPR | Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) | 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. |
| Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection | The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue and bone. |
| Participant-level True Negative Rate (TNR) | Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) | 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. |
| Region-level TNR | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | 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. |
| Participant-level Discrepant PET Negativity Rate | Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) | Percentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive. |
| Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | SUVmax in lesions, visceral soft tissue and bone |
| Biodistribution of 64Cu-SAR-bisPSMA- SUVr | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | Lesion to Background ratio. SUVmax of the lesion divided by the SUVmean of gluteus background |
| Participant-level PPV | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | 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. |
| Participant-level Detection Rate (DR) | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | Percentage of participants with a positive Day 0 or Day 1 scan out of all participants with a Day 0 or Day 1 scan. |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment period: 11 Apr 2022 to 23 Jan 2023
Participants by arm
| Arm | Count |
|---|---|
| 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). | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Participant Non-compliance | 1 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Protocol Violation | 13 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | 64Cu-SAR-bisPSMA Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 39 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Baseline PSA | 2.973 ng/mL STANDARD_DEVIATION 4.1722 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 1 / 52 |
Outcome results
Primary
Participant-level CDR- Day 1
The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.
Time frame: Day 1 (24+/-6 Hours) post injection
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Participant-level CDR- Day 1 | Reader 1 | 33.3 percentage of TP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level CDR- Day 1 | Reader 2 | 33.3 percentage of TP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level CDR- Day 1 | Reader 3 | 26.2 percentage of TP participants |
Primary
Participant-level Correct Detection Rate (CDR)- Day 0
The percentage of TP participants on the Day 0 scan out of all participants with a Day 0 scan.
Time frame: Day 0 (1- 4 hours) post injection
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Participant-level Correct Detection Rate (CDR)- Day 0 | Reader 1 | 26.2 percentage of TP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level Correct Detection Rate (CDR)- Day 0 | Reader 2 | 23.8 percentage of TP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level Correct Detection Rate (CDR)- Day 0 | Reader 3 | 19.0 percentage of TP participants |
Primary
Region-level Positive Predictive Value (PPV)- Day 0
The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Region-level Positive Predictive Value (PPV)- Day 0 | Reader 1 | 41.2 percentage of TP regions |
| 64Cu-SAR-bisPSMA Injection | Region-level Positive Predictive Value (PPV)- Day 0 | Reader 2 | 44.8 percentage of TP regions |
| 64Cu-SAR-bisPSMA Injection | Region-level Positive Predictive Value (PPV)- Day 0 | Reader 3 | 39.1 percentage of TP regions |
Primary
Region-level PPV- Day 1
The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Region-level PPV- Day 1 | Reader 1 | 41.5 percentage of TP regions |
| 64Cu-SAR-bisPSMA Injection | Region-level PPV- Day 1 | Reader 2 | 32.7 percentage of TP regions |
| 64Cu-SAR-bisPSMA Injection | Region-level PPV- Day 1 | Reader 3 | 43.3 percentage of TP regions |
Primary
Safety and Tolerability
Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0
Time frame: up to 7 days post injection
Population: All Participants who received any amount of 64Cu-SAR-bisPSMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Safety and Tolerability | Any TEAE | 10 Participants |
| 64Cu-SAR-bisPSMA Injection | Safety and Tolerability | TEAE Grade 1 to 2 | 8 Participants |
| 64Cu-SAR-bisPSMA Injection | Safety and Tolerability | TEAE Grade 3 | 2 Participants |
| 64Cu-SAR-bisPSMA Injection | Safety and Tolerability | TEAE Grade 4 to 5 | 0 Participants |
| 64Cu-SAR-bisPSMA Injection | Safety and Tolerability | TEAE Related to 64Cu-SAR-bisPSMA | 1 Participants |
| 64Cu-SAR-bisPSMA Injection | Safety and Tolerability | Serious TEAE | 1 Participants |
| 64Cu-SAR-bisPSMA Injection | Safety and Tolerability | Serious TEAE related to Cu64-SAR-bisPSMA | 0 Participants |
| 64Cu-SAR-bisPSMA Injection | Safety and Tolerability | TEAE leading to withdrawal from study | 0 Participants |
| 64Cu-SAR-bisPSMA Injection | Safety and Tolerability | TEAE with fatal outcome | 0 Participants |
Secondary
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
SUVmax in lesions, visceral soft tissue and bone
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 2 All Lesions | 13.914 g/mL | Standard Deviation 10.3342 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 3 Bone Lesions | 16.718 g/mL | Standard Deviation 5.038 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 1 Bone Lesions | 13.05 g/mL | Standard Deviation 6.4444 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 1 Soft Tissue Lesions | 13.746 g/mL | Standard Deviation 9.5714 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 3 All Lesions | 13.924 g/mL | Standard Deviation 7.6483 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 2 Soft Tissue Lesions | 13.680 g/mL | Standard Deviation 11.115 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 2 Bone Lesions | 14.156 g/mL | Standard Deviation 6.0519 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 3 Soft Tissue Lesions | 12.981 g/mL | Standard Deviation 8.1606 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 1 All Lesions | 13.973 g/mL | Standard Deviation 8.9671 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 3 Soft Tissue Lesions | 32.976 g/mL | Standard Deviation 39.5467 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 1 All Lesions | 22.198 g/mL | Standard Deviation 18.6239 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 2 All Lesions | 22.789 g/mL | Standard Deviation 32.398 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 3 All Lesions | 33.363 g/mL | Standard Deviation 37.7745 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 1 Bone Lesions | 27.600 g/mL | Standard Deviation 17.7468 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 2 Bone Lesions | 16.660 g/mL | Standard Deviation 17.969 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 3 Bone Lesions | 37.223 g/mL | Standard Deviation 19.9721 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 1 Soft Tissue Lesions | 21.832 g/mL | Standard Deviation 19.2837 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | Reader 2 Soft Tissue Lesions | 24.068 g/mL | Standard Deviation 33.7881 |
Secondary
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue and bone.
Time frame: Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 2 All Lesions | 8.990 g/mL | Standard Deviation 5.8339 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 3 Bone Lesions | 7.283 g/mL | Standard Deviation 4.4456 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 1 Bone Lesions | 9.188 g/mL | Standard Deviation 4.7099 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 1 Soft Tissue Lesions | 9.706 g/mL | Standard Deviation 6.2907 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 3 All Lesions | 6.635 g/mL | Standard Deviation 3.2447 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 2 Soft Tissue Lesions | 9.018 g/mL | Standard Deviation 6.1432 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 2 Bone Lesions | 8.611 g/mL | Standard Deviation 4.2796 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 3 Soft Tissue Lesions | 6.386 g/mL | Standard Deviation 3.2565 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 1 All Lesions | 9.898 g/mL | Standard Deviation 5.9588 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 3 Soft Tissue Lesions | 14.093 g/mL | Standard Deviation 11.4177 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 1 All Lesions | 15.818 g/mL | Standard Deviation 15.08 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 2 All Lesions | 14.678 g/mL | Standard Deviation 19.4486 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 3 All Lesions | 14.729 g/mL | Standard Deviation 11.1719 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 1 Bone Lesions | 17.699 g/mL | Standard Deviation 10.7888 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 2 Bone Lesions | 10.503 g/mL | Standard Deviation 11.9074 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 3 Bone Lesions | 19.408 g/mL | Standard Deviation 10.9045 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 1 Soft Tissue Lesions | 15.56 g/mL | Standard Deviation 15.5137 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | Reader 2 Soft Tissue Lesions | 15.402 g/mL | Standard Deviation 20.2457 |
Secondary
Biodistribution of 64Cu-SAR-bisPSMA- SUVr
Lesion to Background ratio. SUVmax of the lesion divided by the SUVmean of gluteus background
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVr | Reader 1 All Lesions | 23.233 ratio | Standard Deviation 14.0537 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVr | Reader 2 All Lesions | 23.476 ratio | Standard Deviation 17.3919 |
| 64Cu-SAR-bisPSMA Injection | Biodistribution of 64Cu-SAR-bisPSMA- SUVr | Reader 3 All Lesions | 25.448 ratio | Standard Deviation 15.0785 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVr | Reader 1 All Lesions | 118.051 ratio | Standard Deviation 90.7403 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVr | Reader 2 All Lesions | 121.306 ratio | Standard Deviation 160.9991 |
| SUVmean - Day 1 | Biodistribution of 64Cu-SAR-bisPSMA- SUVr | Reader 3 All Lesions | 181.673 ratio | Standard Deviation 171.6481 |
Secondary
Participant-level Detection Rate (DR)
Percentage of participants with a positive Day 0 or Day 1 scan out of all participants with a Day 0 or Day 1 scan.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Participant-level Detection Rate (DR) | Reader 1 | 58.0 percentage of TP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level Detection Rate (DR) | Reader 2 | 56.0 percentage of TP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level Detection Rate (DR) | Reader 3 | 44.0 percentage of TP participants |
| SUVmean - Day 1 | Participant-level Detection Rate (DR) | Reader 1 | 74.0 percentage of TP participants |
| SUVmean - Day 1 | Participant-level Detection Rate (DR) | Reader 2 | 80.0 percentage of TP participants |
| SUVmean - Day 1 | Participant-level Detection Rate (DR) | Reader 3 | 58.0 percentage of TP participants |
Secondary
Participant-level Discrepant PET Negativity Rate
Percentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Participant-level Discrepant PET Negativity Rate | Reader 1 | 14.3 percentage of participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level Discrepant PET Negativity Rate | Reader 2 | 21.4 percentage of participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level Discrepant PET Negativity Rate | Reader 3 | 42.9 percentage of participants |
Secondary
Participant-level False Positive Rate (FPR)
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Participant-level False Positive Rate (FPR) | Reader 1 | 53.8 percentage of FP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level False Positive Rate (FPR) | Reader 2 | 54.2 percentage of FP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level False Positive Rate (FPR) | Reader 3 | 57.9 percentage of FP participants |
| SUVmean - Day 1 | Participant-level False Positive Rate (FPR) | Reader 1 | 54.8 percentage of FP participants |
| SUVmean - Day 1 | Participant-level False Positive Rate (FPR) | Reader 2 | 60.0 percentage of FP participants |
| SUVmean - Day 1 | Participant-level False Positive Rate (FPR) | Reader 3 | 50.0 percentage of FP participants |
Secondary
Participant-level PPV
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Participant-level PPV | Reader 1 | 44.0 percentage of TP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level PPV | Rader 2 | 43.5 percentage of TP participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level PPV | Reader 3 | 42.1 percentage of TP participants |
| SUVmean - Day 1 | Participant-level PPV | Reader 1 | 45.2 percentage of TP participants |
| SUVmean - Day 1 | Participant-level PPV | Rader 2 | 40.0 percentage of TP participants |
| SUVmean - Day 1 | Participant-level PPV | Reader 3 | 47.8 percentage of TP participants |
Secondary
Participant-level True Negative Rate (TNR)
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Participant-level True Negative Rate (TNR) | Reader 1 | 50.0 percentage of TN participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level True Negative Rate (TNR) | Reader 2 | 53.6 percentage of TN participants |
| 64Cu-SAR-bisPSMA Injection | Participant-level True Negative Rate (TNR) | Reader 3 | 60.7 percentage of TN participants |
| SUVmean - Day 1 | Participant-level True Negative Rate (TNR) | Reader 1 | 39.3 percentage of TN participants |
| SUVmean - Day 1 | Participant-level True Negative Rate (TNR) | Reader 2 | 25.0 percentage of TN participants |
| SUVmean - Day 1 | Participant-level True Negative Rate (TNR) | Reader 3 | 57.1 percentage of TN participants |
Secondary
Region-level FPR
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Region-level FPR | Reader 1 | 58.8 percentage of FP regions |
| 64Cu-SAR-bisPSMA Injection | Region-level FPR | Reader 2 | 55.2 percentage of FP regions |
| 64Cu-SAR-bisPSMA Injection | Region-level FPR | Reader 3 | 60.9 percentage of FP regions |
| SUVmean - Day 1 | Region-level FPR | Reader 1 | 57.1 percentage of FP regions |
| SUVmean - Day 1 | Region-level FPR | Reader 2 | 67.3 percentage of FP regions |
| SUVmean - Day 1 | Region-level FPR | Reader 3 | 56.7 percentage of FP regions |
Secondary
Region-level TNR
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 64Cu-SAR-bisPSMA Injection | Region-level TNR | Reader 1 | 88.7 percentage of TN regions |
| 64Cu-SAR-bisPSMA Injection | Region-level TNR | Reader 2 | 91.0 percentage of TN regions |
| 64Cu-SAR-bisPSMA Injection | Region-level TNR | Reader 3 | 92.1 percentage of TN regions |
| SUVmean - Day 1 | Region-level TNR | Reader 1 | 86.4 percentage of TN regions |
| SUVmean - Day 1 | Region-level TNR | Reader 2 | 80.1 percentage of TN regions |
| SUVmean - Day 1 | Region-level TNR | Reader 3 | 90.4 percentage of TN regions |