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

Completed · Phase 2

Conditions studied: Biochemical Recurrence of Malignant Neoplasm of Prostate

In brief

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.

Key facts

Study ID

NCT05407311

Run by

Clarity Pharmaceuticals Ltd

People needed

53

Starts

2022-09-19

Expected to finish

2024-05-13

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age.
• Signed informed consent.
• Life expectancy ≥ 12 weeks as determined by the Investigator.
• Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
• Suspected recurrence of PC based on rising PSA after definitive therapy on the basis of:
• 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
• 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).
• 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.
• The Eastern Cooperative Oncology performance status 0-2.
• Adequate recovery from acute toxic effects of any prior therapy.
• Estimated Glomerular Filtration Rate of 30 mL/min or higher.
• Adequate liver function.
• For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

You may not qualify if…

• Participants who received other investigational agents within 28 days prior to Day 0.
• Participants administered any high energy (>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0.
• 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.
• 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.
• Known or expected hypersensitivity to 64Cu-SAR-BBN or any of its components.
• Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.