| Primary | Safety and Tolerability | Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | All Participants who received any amount of 64Cu-SAR-BBN. | Posted | | Count of Participants | | Participants | | Up to 7 days post injection | | | | ID | Title | Description |
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| OG000 | 64Cu-SAR-BBN | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 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 true positive (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-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at Day 0. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 0 (1-4 hours) post injection | | | | ID | Title | Description |
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| OG000 | 64Cu-SAR-BBN | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 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-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at Day 1. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 1 (24+/-6 Hours) post injection | | | | ID | Title | Description |
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| OG000 | 64Cu-SAR-BBN | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 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-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at Day 0. | Posted | | Number | 95% Confidence Interval | percentage of regions | | Day 0 (1-4 hours) post injection | Regions | Regions | | ID | Title | Description |
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| OG000 | 64Cu-SAR-BBN | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 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-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at Day 1. | Posted | | Number | 95% Confidence Interval | percentage of regions | | Day 1 (24 +/- 6 hours) post injection | Regions | Regions | | ID | Title | Description |
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| OG000 | 64Cu-SAR-BBN | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. |
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| Secondary | Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0 | The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue, bone. | All enrolled participants who received any amount of 64Cu-SAR-BBN 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 | kg/L | | Day 0 (1-4 hours) post injection | | | | ID | Title | Description |
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| OG000 | Reader 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Reader 2 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG002 |
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| Secondary | Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1 | The SUVmean in lesions, visceral soft tissue, bone. | All enrolled participants who received any amount of 64Cu-SAR-BBN 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 | kg/L | | Day 1 (24 +/- 6 hours) post injection | | | | ID | Title | Description |
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| OG000 | Reader 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Reader 2 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG002 | Reader 3 |
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| Secondary | Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0 | The max Standardized Uptake Value (SUVmax) in lesions, visceral soft tissue and bone. | All enrolled participants who received any amount of 64Cu-SAR-BBN 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 | kg/L | | Day 0 (1-4 hours) post injection | | | | ID | Title | Description |
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| OG000 | Reader 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Reader 2 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG002 |
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| Secondary | Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1 | The SUVmax in lesions, visceral soft tissue and bone. | All enrolled participants who received any amount of 64Cu-SAR-BBN 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 | kg/L | | Day 1 (24 +/- 6 hours) post injection | | | | ID | Title | Description |
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| OG000 | Reader 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Reader 2 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG002 | Reader 3 |
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| Secondary | Biodistribution of 64Cu-SAR-BBN - SUVr - Day 0 | Standardized Uptake Value Lesion to Background ratio (SUVr): SUVmax of the lesion divided by the SUVmean of gluteus background. | All enrolled participants who received any amount of 64Cu-SAR-BBN 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) post injection | | | | ID | Title | Description |
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| OG000 | Reader 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Reader 2 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG002 |
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| Secondary | Biodistribution of 64Cu-SAR-BBN - SUVr - Day 1 | SUVr: SUVmax of the lesion divided by the SUVmean of gluteus background. | All enrolled participants who received any amount of 64Cu-SAR-BBN 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 1 (24 +/- 6 hours) post injection | | | | ID | Title | Description |
|---|
| OG000 | Reader 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Reader 2 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG002 | Reader 3 |
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| Secondary | Participant-level PPV | Percentage of TP participants out of all positive participants, derived separately for each timepoint and reader. | All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection | | | | ID | Title | Description |
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| OG000 | Participant-level PPV - Day 0 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Participant-level PPV - Day 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. |
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| Secondary | Participant-level Detection Rate (DR) | Percentage of participants with a positive 64Cu-SAR-BBN PET/CT scan out of all participants with a 64Cu-SAR-BBN PET/CT scan for each timepoint and reader. | All participants who received any amount of 64Cu-SAR-BBN and had a 64Cu-SAR-BBN PET/CT scan at the given timepoint. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection | | | | ID | Title | Description |
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| OG000 | Participant-level DR - Day 0 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Participant-level DR - Day 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. |
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| Secondary | Participant-level False Positive Rate (FPR) | Percentage of false positive (FP) participants out of all participants with a positive scan, derived separately for each timepoint and reader. | All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection | | | | ID | Title | Description |
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| OG000 | Participant-level FPR - Day 0 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Participant-level FPR - Day 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 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, derived separately for each timepoint and reader. | All participants who received any amount of 64Cu-SAR-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint. | Posted | | Number | 95% Confidence Interval | percentage of regions | | Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection | Regions | Regions | | ID | Title | Description |
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| OG000 | Region-level FPR - Day 0 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Region-level FPR - Day 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 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-BBN with 64Cu-SAR-BBN 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) post injection | | | | ID | Title | Description |
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| OG000 | 64Cu-SAR-BBN | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. |
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| Secondary | Participant-level True Negative Rate (TNR) | Percentage of true negative (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-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection | | | | ID | Title | Description |
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| OG000 | Participant-level TNR - Day 0 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Participant-level TNR - Day 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 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-BBN and had 64Cu-SAR-BBN PET/CT imaging results from at least one central reader, excluding participants with non-evaluable Reference Standard results or without an evaluable 64Cu-SAR-BBN PET/CT scan central reader result, at the given timepoint. | Posted | | Number | 95% Confidence Interval | percentage of regions | | Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection | Regions | Regions | | ID | Title | Description |
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| OG000 | Region-level TNR - Day 0 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. | | OG001 | Region-level TNR - Day 1 | Participants with suspected biochemical recurrence of PC following definitive therapy with negative or equivocal findings for PC on an approved PSMA PET and anatomical imaging (CT and/or MRI) and other SOC conventional imaging received a single intravenous injection of 200 MBq of 64Cu-SAR-BBN, followed by a PET/CT scan at 1 to 4 hours post injection and at 24 +/- 6 hours post injection. |
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