64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer

Launched by CLARITY PHARMACEUTICALS LTD · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called 64Cu-SAR-bisPSMA PET/CT, which aims to find out how well it can detect prostate cancer that has come back after treatment. The trial is specifically looking for men aged 65 to 74 who have had a prostatectomy (surgery to remove the prostate) or other forms of treatment like radiation or cryotherapy, and who now have a rising PSA level. PSA, or prostate-specific antigen, is a substance made by the prostate, and higher levels can indicate that cancer may have returned.

To be eligible for this study, participants must be at least 18 years old, sign a consent form, and have a life expectancy of at least six months. They also need to agree to have a biopsy of any areas that show up on the PET scan as potentially cancerous. If you join the study, you can expect to undergo this new type of imaging and possibly a biopsy to confirm the presence of cancer. It's important to know that the study is not yet recruiting participants, so there may be a wait before it starts.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years of age.
• • 2. Signed informed consent.
• • 3. Life expectancy ≥ 6 months as determined by the Investigator.
• • 4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
• • 5. Participant potentially eligible for salvage therapy with curative intent.
• 6. PSA level after definitive therapy:
• • 1. 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
• • 2. 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).
• • 7. Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
• • 8. An Eastern Cooperative Oncology performance status of 0-2.
• Exclusion Criteria:
• • 1. Participants who received investigational agent within 5 biological half-lives prior to Day 1.
• • 2. Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
• • 3. Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy).
• • 4. 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.
• • 5. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
• • 6. 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.