Status:
RECRUITING
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
Lead Sponsor:
Clarity Pharmaceuticals Ltd
Conditions:
Prostate Cancer
Prostate Cancer Patients With Detectable PSA Following Prostatectomy
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Signed informed consent.
- Life expectancy ≥ 6 months as determined by the Investigator.
- Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
- Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
- PSA level after definitive therapy:
- Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or
- Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
- Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
- An Eastern Cooperative Oncology performance status of 0-2.
Exclusion
- Participants who received investigational agent within 5 biological half-lives prior to Day 1.
- Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
- Participants with known predominant small cell or neuroendocrine PC.
- Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation).
- Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC.
- Participants for whom there is an intent to initiate a prohibited medication(s)/treatment(s) (refer to Section 7.3) during the course of the participant's involvement in the study.
- Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
- Any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a PET scan) which the investigator feels may interfere with the procedures or evaluations of the study.
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06970847
Start Date
May 16 2025
End Date
December 31 2026
Last Update
December 17 2025
Active Locations (27)
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1
East Valley Urology Center of Arizona
Mesa, Arizona, United States, 85297
2
Arkansas Urology Research Center
Little Rock, Arkansas, United States, 72211
3
UC Irvine
Irvine, California, United States, 92697
4
Comprehensive Urology Medical Group
Los Angeles, California, United States, 90048