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

October 30, 2025 updated by: Clarity Pharmaceuticals Ltd

64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with prostate-specific membrane antigen (PSMA)-negative biochemical recurrence of prostate cancer following definitive therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants with biochemical evidence of recurrence of prostate cancer (PC) were evaluated with 64Cu-SAR-BBN PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later (e.g., histopathology/biopsy, conventional imaging, prostate specific antigen [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-BBN PET/CT. Three separate independent readers assessed the results of the conventional methodologies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • Stanford, California, United States, 94305
        • Stanford University
    • Florida
      • Miami, Florida, United States, 33165
        • Biogenix Molecular
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Bamf Health, Inc
    • Missouri
      • St Louis, Missouri, United States, 63104
        • St Louis University Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • GU Research Network
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Texas
      • San Antonio, Texas, United States, 78258
        • Urology San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 PC based on rising 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 (1) approved PSMA PET and (2) anatomical imaging (CT and/or magnetic resonance imaging) and (3) if available, any other conventional imaging performed as part of routine standard of care imaging 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. Participants who are known to require prohibited treatment (e.g., initiation of androgen-deprivation therapy due to rapidly rising PSA) before the 64Cu-SAR-BBN PET/CT results can be verified via histopathology or follow-up imaging.
  5. Known or expected hypersensitivity to 64Cu-SAR-BBN or any of its components.
  6. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 64Cu-SAR-BBN
Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-BBN.
Drug: 64Cu-SAR-BBN
64Cu-SAR-BBN

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: Up to 7 days post injection
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.
Up to 7 days post injection
Participant-level Correct Detection Rate (CDR) - Day 0
Time Frame: Day 0 (1-4 hours) post injection
The percentage of true positive (TP) participants on the Day 0 scan out of all participants with a Day 0 scan.
Day 0 (1-4 hours) post injection
Participant-level CDR - Day 1.
Time Frame: 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.
Day 1 (24+/-6 Hours) post injection
Region-level Positive Predictive Value (PPV) - Day 0.
Time Frame: Day 0 (1-4 hours) post injection
The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.
Day 0 (1-4 hours) post injection
Region-level PPV - Day 1.
Time Frame: Day 1 (24 +/- 6 hours) post injection
The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.
Day 1 (24 +/- 6 hours) post injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0
Time Frame: Day 0 (1-4 hours) post injection
The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue, bone.
Day 0 (1-4 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1
Time Frame: Day 1 (24 +/- 6 hours) post injection
The SUVmean in lesions, visceral soft tissue, bone.
Day 1 (24 +/- 6 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0
Time Frame: Day 0 (1-4 hours) post injection
The max Standardized Uptake Value (SUVmax) in lesions, visceral soft tissue and bone.
Day 0 (1-4 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1
Time Frame: Day 1 (24 +/- 6 hours) post injection
The SUVmax in lesions, visceral soft tissue and bone.
Day 1 (24 +/- 6 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVr - Day 0
Time Frame: Day 0 (1-4 hours) post injection
Standardized Uptake Value Lesion to Background ratio (SUVr): SUVmax of the lesion divided by the SUVmean of gluteus background.
Day 0 (1-4 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVr - Day 1
Time Frame: Day 1 (24 +/- 6 hours) post injection
SUVr: SUVmax of the lesion divided by the SUVmean of gluteus background.
Day 1 (24 +/- 6 hours) post injection
Participant-level PPV
Time Frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
Percentage of TP participants out of all positive participants, derived separately for each timepoint and reader.
Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
Participant-level Detection Rate (DR)
Time Frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
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.
Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
Participant-level False Positive Rate (FPR)
Time Frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
Percentage of false positive (FP) participants out of all participants with a positive scan, derived separately for each timepoint and reader.
Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
Region-level FPR
Time Frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection
Percentage of FP regions on the Day 0 or Day 1 scan out of all positive regions, derived separately for each timepoint and reader.
Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection
Participant-level Discrepant PET Negativity Rate
Time Frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection
Percentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive.
Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection
Participant-level True Negative Rate (TNR)
Time Frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection
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.
Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection
Region-level TNR
Time Frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
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.
Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clarity Pharmaceuticals Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLB03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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