64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

Completed · Phase 1/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-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.

Key facts

Study ID

NCT05249127

Run by

Clarity Pharmaceuticals Ltd

People needed

52

Starts

2022-04-11

Expected to finish

2023-08-08

Last updated by the study team

2024-10-01

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 prostate cancer (PC) based on rising Prostate-specific antigen (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 conventional imaging performed as part of standard of care 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.
• Known or expected hypersensitivity to 64Cu-SAR-bisPSMA 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
• GU Research Network — Omaha, Nebraska, United States
• New Mexico Cancer Center — Albuquerque, New Mexico, 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

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