| 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 | All Participants who received any amount of 64Cu-SAR-bisPSMA. | Posted | | Count of Participants | | Participants | No | up to 7 days post injection | | | | ID | Title | Description |
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| OG000 | 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). |
| | | Title | Denominators | Categories |
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| Any TEAE | | | | TEAE Grade 1 to 2 | | | | TEAE Grade 3 | | |
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| 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. | 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). | Posted | | Number | 95% Confidence Interval | percentage of TP participants | | Day 0 (1- 4 hours) post injection | | | | ID | Title | Description |
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| OG000 | 64Cu-SAR-bisPSMA | 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). |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of TP participants | | Day 1 (24+/-6 Hours) post injection | | | | ID | Title | Description |
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| OG000 | 64Cu-SAR-bisPSMA PET 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). |
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| 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. | 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). | Posted | | Number | 95% Confidence Interval | percentage of TP regions | | Day 0 (1- 4 hours) | Regions | Regions | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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). | Posted | | Number | 95% Confidence Interval | percentage of TP regions | | Day 1 (24 +/- 6 hours) | Regions | Regions | | ID | Title | Description |
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| OG000 | 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). |
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| Secondary | Biodistribution of 64Cu-SAR-bisPSMA- SUVmean | The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue and bone. | 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. | Posted | | Mean | Standard Deviation | g/mL | | Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection | | | | ID | Title | Description |
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| OG000 | SUVmean- Day 0 | 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). | | OG001 | 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). |
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| Secondary | Biodistribution of 64Cu-SAR-bisPSMA- SUVmax | SUVmax in lesions, visceral soft tissue and bone | 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. | Posted | | Mean | Standard Deviation | g/mL | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | | | | ID | Title | Description |
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| OG000 | SUVmax- Day 0 | 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). | | OG001 | SUVmax- 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). |
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| Secondary | Biodistribution of 64Cu-SAR-bisPSMA- SUVr | Lesion to Background ratio. SUVmax of the lesion divided by the SUVmean of gluteus background | 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. | Posted | | Mean | Standard Deviation | ratio | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | | | | ID | Title | Description |
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| OG000 | SUVr - Day 0 | 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). | | OG001 | SUVr - 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). |
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| 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. | 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). | Posted | | Number | 95% Confidence Interval | percentage of TP participants | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | | | | ID | Title | Description |
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| OG000 | Participant-level PPV- Day 0 | 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). | | OG001 | Participant-level PPV- Day 1 | Single Arm: Participants with suspected recurrence of prostate cancer (PC) based on detectable or rising Prostate Specific Antigen (PSA) following definitive therapy, who had negative or equivocal findings on institutional standard of care (SOC) 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). |
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| 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. | 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 | Posted | | Number | 95% Confidence Interval | percentage of TP participants | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | | | | ID | Title | Description |
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| OG000 | Participant-level DR- Day 0 | 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) | | OG001 | Participant-level DR- 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) |
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| 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. | 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). | Posted | | Number | 95% Confidence Interval | percentage of FP participants | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | | | | ID | Title | Description |
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| OG000 | Participant-level FPR- Day 0 | 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). | | OG001 | Participant-level FPR- 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). |
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| 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. | 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). | Posted | | Number | 95% Confidence Interval | percentage of FP regions | | Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) | regions | regions | | ID | Title | Description |
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| OG000 | Region-level FPR-Day 0 | 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). | | OG001 | Region-level FPR-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). |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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). | Posted | | Number | 95% Confidence Interval | percentage of TN participants | | Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) | | | | ID | Title | Description |
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| OG000 | Participant-level TNR- Day 0 | 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). | | OG001 | Participant-level TNR- 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). |
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| 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. | 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). | Posted | | Number | 95% Confidence Interval | percentage of TN regions | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) | regions | regions | | ID | Title | Description |
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| OG000 | Region-level TNR-Day 0 | 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). | | OG001 | Region-level TNR- 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). |
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