64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical R… (NCT06970847) | Clinical Trial Compass
RecruitingPhase 3
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
United States220 participantsStarted 2025-05-16
Plain-language summary
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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).
What they're measuring
1
Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
✕. 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.