Home › Trials › NCT06970847

64Cu-SAR-bisPSMA PET/CT to find recurrent prostate cancer

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

PHASE3 · Clarity Pharmaceuticals Ltd · NCT06970847

This trial will test a PET/CT scan called 64Cu-SAR-bisPSMA to find returning prostate cancer in men with a rising PSA after prostatectomy or radiation.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years and up
SexMale
SponsorClarity Pharmaceuticals Ltd (industry)
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations28 sites (Mesa, Arizona and 27 other locations)
Trial IDNCT06970847 on ClinicalTrials.gov

What this trial studies

Participants are men with histologically confirmed prostate adenocarcinoma who have completed definitive therapy and now meet PSA-based criteria for biochemical recurrence. They will receive a 64Cu-SAR-bisPSMA PET/CT scan and, where safe and feasible, biopsy of PET-positive lesions for histologic confirmation. The study is a Phase 3, multi-center interventional trial designed to compare imaging findings with tissue confirmation and inform potential salvage loco-regional therapy. Imaging and follow-up visits occur at participating centers in Arizona, Arkansas, and California.

Who should consider this trial

Good fit: Ideal candidates are adults with prior definitive treatment for prostate adenocarcinoma who now have biochemical recurrence by PSA thresholds and are potential candidates for salvage curative-intent therapy.

Not a fit: Patients without a PSA rise, with widespread metastatic disease, or who cannot undergo PET/CT or biopsy are unlikely to benefit from this imaging approach.

Why it matters

Potential benefit: If successful, the scan could more accurately locate recurrent prostate cancer and better guide curative-intent salvage treatments.

How similar studies have performed: Other PSMA-targeted PET agents (for example 68Ga- and 18F-PSMA tracers) have shown high detection rates in biochemical recurrence, but 64Cu-SAR-bisPSMA is a newer agent with less published Phase 3 evidence.

Eligibility criteria

Show full inclusion / exclusion 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 (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
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. Participants with known predominant small cell or neuroendocrine PC.
4. 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).
5. 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.
6. 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.
7. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
8. 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.

Where this trial is running

Mesa, Arizona and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Prostate Cancer, Prostate Cancer Patients With Detectable PSA Following Prostatectomy, Prostate Cancer Recurrent, Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients Treated by Radiotherapy, Cryotherapy, Prostate, Biochemical Recurrence

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.