Trial Outcomes & Findings for 64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE) (NCT NCT05407311)

NCT ID: NCT05407311

Last Updated: 2025-11-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: Up to 7 days post injection
• Results posted on: 2025-11-17

Participant Flow

Dates of recruitment period: 19 Sep 2022 to 14 Nov 2023

Participant milestones

Measure	64Cu-SAR-BBN Participants with suspected biochemical recurrence of prostate cancer (PC) following definitive therapy with negative or equivocal findings for PC on an approved prostate-specific membrane antigen (PSMA) positron emission tomography (PET) and anatomical imaging (computed tomography \[CT\] and/or magnetic resonance imaging \[MRI\]) and other standard of care (SOC) conventional imaging received a single intravenous injection of 200 megabecquerels (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.
Overall Study STARTED	53
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	64Cu-SAR-BBN Participants with suspected biochemical recurrence of prostate cancer (PC) following definitive therapy with negative or equivocal findings for PC on an approved prostate-specific membrane antigen (PSMA) positron emission tomography (PET) and anatomical imaging (computed tomography \[CT\] and/or magnetic resonance imaging \[MRI\]) and other standard of care (SOC) conventional imaging received a single intravenous injection of 200 megabecquerels (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.
Overall Study Withdrawal by Subject	5
Overall Study Protocol Violation	3
Overall Study Physician Decision	1
Overall Study Non-compliance	1

Baseline Characteristics

64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

Baseline characteristics by cohort

Measure	64Cu-SAR-BBN n=53 Participants 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.
Age, Categorical <=18 years	0 Participants n=202 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=202 Participants
Age, Categorical >=65 years	41 Participants n=202 Participants
Sex: Female, Male Female	0 Participants n=202 Participants
Sex: Female, Male Male	53 Participants n=202 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=202 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=202 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=202 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=202 Participants
Race (NIH/OMB) Asian	0 Participants n=202 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants
Race (NIH/OMB) Black or African American	5 Participants n=202 Participants
Race (NIH/OMB) White	48 Participants n=202 Participants
Race (NIH/OMB) More than one race	0 Participants n=202 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=202 Participants
Region of Enrollment United States	53 participants n=202 Participants
Baseline Prostate Specific Antigen (PSA)	3.3932 ng/mL STANDARD_DEVIATION 6.13380 • n=202 Participants

PRIMARY outcome

Timeframe: Up to 7 days post injection

Population: All Participants who received any amount of 64Cu-SAR-BBN.

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.

Outcome measures

Measure	64Cu-SAR-BBN n=53 Participants 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.	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.	Reader 3 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.
Safety and Tolerability TEAE Leading to Discontinuation of Study	0 Participants	—	—
Safety and Tolerability TEAE Leading to Death	0 Participants	—	—
Safety and Tolerability TEAE Related to 64Cu-SAR-BBN	2 Participants	—	—
Safety and Tolerability Serious TEAE	0 Participants	—	—
Safety and Tolerability Any TEAE	8 Participants	—	—
Safety and Tolerability TEAE Grade 1 to 2	8 Participants	—	—
Safety and Tolerability TEAE Grade 3	0 Participants	—	—
Safety and Tolerability TEAE Grade 4 to 5	0 Participants	—	—

PRIMARY outcome

Timeframe: Day 0 (1-4 hours) post injection

Population: 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.

The percentage of true positive (TP) participants on the Day 0 scan out of all participants with a Day 0 scan.

Outcome measures

Measure	64Cu-SAR-BBN n=47 Participants 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.	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.	Reader 3 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.
Participant-level Correct Detection Rate (CDR) - Day 0 Reader 1	14.9 percentage of participants Interval 6.2 to 28.3	—	—
Participant-level Correct Detection Rate (CDR) - Day 0 Reader 2	14.9 percentage of participants Interval 6.2 to 28.3	—	—
Participant-level Correct Detection Rate (CDR) - Day 0 Reader 3	14.9 percentage of participants Interval 6.2 to 28.3	—	—

PRIMARY outcome

Timeframe: Day 1 (24+/-6 Hours) post injection

Population: 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.

The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.

Outcome measures

Measure	64Cu-SAR-BBN n=47 Participants 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.	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.	Reader 3 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.
Participant-level CDR - Day 1. Reader 1	4.3 percentage of participants Interval 0.5 to 14.5	—	—
Participant-level CDR - Day 1. Reader 2	10.6 percentage of participants Interval 3.5 to 23.1	—	—
Participant-level CDR - Day 1. Reader 3	14.9 percentage of participants Interval 6.2 to 28.3	—	—

PRIMARY outcome

Timeframe: Day 0 (1-4 hours) post injection

Population: 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.

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-BBN n=235 Regions 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.	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.	Reader 3 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.
Region-level Positive Predictive Value (PPV) - Day 0. Reader 1	47.1 percentage of regions Interval 23.0 to 72.2	—	—
Region-level Positive Predictive Value (PPV) - Day 0. Reader 2	22.6 percentage of regions Interval 9.6 to 41.1	—	—
Region-level Positive Predictive Value (PPV) - Day 0. Reader 3	33.3 percentage of regions Interval 15.6 to 55.3	—	—

PRIMARY outcome

Timeframe: Day 1 (24 +/- 6 hours) post injection

Population: 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.

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-BBN n=235 Regions 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.	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.	Reader 3 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.
Region-level PPV - Day 1. Reader 1	22.2 percentage of regions Interval 2.8 to 60.0	—	—
Region-level PPV - Day 1. Reader 2	35.3 percentage of regions Interval 14.2 to 61.7	—	—
Region-level PPV - Day 1. Reader 3	37.5 percentage of regions Interval 18.8 to 59.4	—	—

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) post injection

Population: 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.

The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue, bone.

Outcome measures

Measure	64Cu-SAR-BBN n=14 Participants 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.	Reader 2 n=23 Participants 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.	Reader 3 n=21 Participants 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.
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0 All Lesions	5.470 kg/L Standard Deviation 3.2058	3.773 kg/L Standard Deviation 2.5440	5.671 kg/L Standard Deviation 8.0303
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0 Soft Tissue Lesions	5.699 kg/L Standard Deviation 3.5380	4.362 kg/L Standard Deviation 2.9050	6.427 kg/L Standard Deviation 8.5057
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0 Bone Lesions	3.703 kg/L Standard Deviation NA No standard deviation when n=1	2.482 kg/L Standard Deviation 1.2925	2.353 kg/L Standard Deviation 2.0118

SECONDARY outcome

Timeframe: Day 1 (24 +/- 6 hours) post injection

Population: 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.

The SUVmean in lesions, visceral soft tissue, bone.

Outcome measures

Measure	64Cu-SAR-BBN n=9 Participants 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.	Reader 2 n=15 Participants 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.	Reader 3 n=20 Participants 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.
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1 All Lesions	2.586 kg/L Standard Deviation 1.9814	1.450 kg/L Standard Deviation 1.5305	1.179 kg/L Standard Deviation 1.5309
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1 Soft Tissue Lesions	2.586 kg/L Standard Deviation 1.9814	1.586 kg/L Standard Deviation 1.7712	1.652 kg/L Standard Deviation 2.0244
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1 Bone Lesions	—	2.116 kg/L Standard Deviation 2.3684	0.772 kg/L Standard Deviation 0.4263

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) post injection

Population: 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.

The max Standardized Uptake Value (SUVmax) in lesions, visceral soft tissue and bone.

Outcome measures

Measure	64Cu-SAR-BBN n=14 Participants 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.	Reader 2 n=23 Participants 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.	Reader 3 n=21 Participants 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.
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0 All Lesions	7.335 kg/L Standard Deviation 4.0904	5.314 kg/L Standard Deviation 3.1471	14.436 kg/L Standard Deviation 27.7988
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0 Soft Tissue Lesions	7.705 kg/L Standard Deviation 4.7952	5.910 kg/L Standard Deviation 3.8559	16.368 kg/L Standard Deviation 29.7231
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0 Bone Lesions	5.041 kg/L Standard Deviation NA No standard deviation when n=1	4.144 kg/L Standard Deviation 1.8181	5.013 kg/L Standard Deviation 3.6903

SECONDARY outcome

Timeframe: Day 1 (24 +/- 6 hours) post injection

Population: 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.

The SUVmax in lesions, visceral soft tissue and bone.

Outcome measures

Measure	64Cu-SAR-BBN n=9 Participants 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.	Reader 2 n=15 Participants 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.	Reader 3 n=20 Participants 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.
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1 All Lesions	4.179 kg/L Standard Deviation 3.3173	2.762 kg/L Standard Deviation 3.5449	2.763 kg/L Standard Deviation 3.2511
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1 Bone Lesions	—	5.017 kg/L Standard Deviation 6.2016	1.945 kg/L Standard Deviation 0.8572
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1 Soft Tissue Lesions	4.179 kg/L Standard Deviation 3.3173	2.930 kg/L Standard Deviation 4.1078	3.965 kg/L Standard Deviation 4.5243

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) post injection

Population: 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.

Standardized Uptake Value Lesion to Background ratio (SUVr): SUVmax of the lesion divided by the SUVmean of gluteus background.

Outcome measures

Measure	64Cu-SAR-BBN n=14 Participants 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.	Reader 2 n=23 Participants 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.	Reader 3 n=21 Participants 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.
Biodistribution of 64Cu-SAR-BBN - SUVr - Day 0	14.566 ratio Standard Deviation 8.1016	10.020 ratio Standard Deviation 5.1889	13.442 ratio Standard Deviation 17.6749

SECONDARY outcome

Timeframe: Day 1 (24 +/- 6 hours) post injection

Population: 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.

SUVr: SUVmax of the lesion divided by the SUVmean of gluteus background.

Outcome measures

Measure	64Cu-SAR-BBN n=9 Participants 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.	Reader 2 n=15 Participants 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.	Reader 3 n=20 Participants 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.
Biodistribution of 64Cu-SAR-BBN - SUVr - Day 1	55.957 ratio Standard Deviation 36.4771	40.617 ratio Standard Deviation 24.7419	36.254 ratio Standard Deviation 45.2321

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection

Population: 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.

Percentage of TP participants out of all positive participants, derived separately for each timepoint and reader.

Outcome measures

Measure	64Cu-SAR-BBN n=47 Participants 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.	Reader 2 n=47 Participants 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.	Reader 3 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.
Participant-level PPV Reader 1	58.3 percentage of participants Interval 27.7 to 84.8	33.3 percentage of participants Interval 4.3 to 77.7	—
Participant-level PPV Reader 2	31.8 percentage of participants Interval 13.9 to 54.9	38.5 percentage of participants Interval 13.9 to 68.4	—
Participant-level PPV Reader 3	36.8 percentage of participants Interval 16.3 to 61.6	43.8 percentage of participants Interval 19.8 to 70.1	—

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection

Population: All participants who received any amount of 64Cu-SAR-BBN and had a 64Cu-SAR-BBN PET/CT scan at the given timepoint.

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.

Outcome measures

Measure	64Cu-SAR-BBN n=53 Participants 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.	Reader 2 n=53 Participants 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.	Reader 3 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.
Participant-level Detection Rate (DR) Reader 1	24.5 percentage of participants Interval 13.8 to 38.3	17.0 percentage of participants Interval 8.1 to 29.8	—
Participant-level Detection Rate (DR) Reader 3	37.7 percentage of participants Interval 24.8 to 52.1	37.7 percentage of participants Interval 24.8 to 52.1	—
Participant-level Detection Rate (DR) Reader 2	43.4 percentage of participants Interval 29.8 to 57.7	28.3 percentage of participants Interval 16.8 to 42.3	—

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection

Population: 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.

Percentage of false positive (FP) participants out of all participants with a positive scan, derived separately for each timepoint and reader.

Outcome measures

Measure	64Cu-SAR-BBN n=47 Participants 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.	Reader 2 n=47 Participants 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.	Reader 3 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.
Participant-level False Positive Rate (FPR) Reader 1	41.7 percentage of participants Interval 15.2 to 72.3	66.7 percentage of participants Interval 22.3 to 95.7	—
Participant-level False Positive Rate (FPR) Reader 2	68.2 percentage of participants Interval 45.1 to 86.1	61.5 percentage of participants Interval 31.6 to 86.1	—
Participant-level False Positive Rate (FPR) Reader 3	63.2 percentage of participants Interval 38.4 to 83.7	56.3 percentage of participants Interval 29.9 to 80.2	—

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection

Population: 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.

Percentage of FP regions on the Day 0 or Day 1 scan out of all positive regions, derived separately for each timepoint and reader.

Outcome measures

Measure	64Cu-SAR-BBN n=235 Regions 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.	Reader 2 n=235 Regions 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.	Reader 3 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.
Region-level FPR Reader 1	52.9 percentage of regions Interval 27.8 to 77.0	77.8 percentage of regions Interval 40.0 to 97.2	—
Region-level FPR Reader 2	77.4 percentage of regions Interval 58.9 to 90.4	64.7 percentage of regions Interval 38.3 to 85.8	—
Region-level FPR Reader 3	66.7 percentage of regions Interval 44.7 to 84.4	62.5 percentage of regions Interval 40.6 to 81.2	—

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection

Population: 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.

Percentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive.

Outcome measures

Measure	64Cu-SAR-BBN n=19 Participants 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.	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.	Reader 3 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.
Participant-level Discrepant PET Negativity Rate Reader 1	26.3 percentage of participants Interval 9.1 to 51.2	—	—
Participant-level Discrepant PET Negativity Rate Reader 2	15.8 percentage of participants Interval 3.4 to 39.6	—	—
Participant-level Discrepant PET Negativity Rate Reader 3	10.5 percentage of participants Interval 1.3 to 33.1	—	—

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection

Population: 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.

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.

Outcome measures

Measure	64Cu-SAR-BBN n=47 Participants 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.	Reader 2 n=47 Participants 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.	Reader 3 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.
Participant-level True Negative Rate (TNR) Reader 1	82.1 percentage of participants Interval 63.1 to 93.9	85.7 percentage of participants Interval 67.3 to 96.0	—
Participant-level True Negative Rate (TNR) Reader 2	57.1 percentage of participants Interval 39.4 to 73.7	77.1 percentage of participants Interval 59.9 to 89.6	—
Participant-level True Negative Rate (TNR) Reader 3	58.6 percentage of participants Interval 38.9 to 76.5	69.0 percentage of participants Interval 49.2 to 84.7	—

SECONDARY outcome

Timeframe: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection

Population: 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.

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-BBN n=235 Regions 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.	Reader 2 n=235 Regions 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.	Reader 3 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.
Region-level TNR Reader 1	95.8 percentage of regions Interval 92.2 to 98.1	96.7 percentage of regions Interval 93.4 to 98.7	—
Region-level TNR Reader 2	88.2 percentage of regions Interval 82.9 to 92.3	94.6 percentage of regions Interval 90.6 to 97.3	—
Region-level TNR Reader 3	92.6 percentage of regions Interval 88.2 to 95.7	93.0 percentage of regions Interval 88.8 to 96.0	—

Adverse Events

64Cu-SAR-BBN

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

64Cu-SAR-BBN n=53 participants at risk Participants with suspected biochemical recurrence of prostate cancer (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 standard of care (SOC) conventional imaging received a single intravenous injection of 200 megabecquerels (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.

Nervous system disorders Headache

5.7% 3/53 • Number of events 3 • From time of informed consent up to 7 days post injection Adverse event monitoring occurred at screening, on Day 0 pre- and post-dose, and up to 7 days post injection (Day 7). Physical exam performed pre-dose on Day 0 and on Day 7. Vital signs collected pre- and post-dose on Day 0 and on Day 7. Duplicate 12-Lead electrocardiogram (ECG) performed pre- and post-dose on Day 0. Hematology, biochemistry, coagulation, and estimated glomerular filtration rate (eGFR) performed at screening and Day 7. Urinalysis performed pre-dose on Day 0 and on Day 7.

Additional Information

Dr. Othon Gervasio, Chief Medical Officer

Clarity Pharmaceuticals

Phone: +61 (0)2 9209 4037

Email: info@claritypharmaceuticals.com

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