🏛️ Verified NIH Record • Updated 2026-05-04
64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) (NCT04868604)
🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Clarity Pharmaceuticals Ltd
🩺 Plain-English Summary (8th-Grade Level)
The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (27 items) and avoid the listed exclusions (24 items).
Location: Stanford Cancer Institute — Stanford, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Major surgery within 12 weeks prior to enrollment into the study;
- Brain metastasis;
- Histologic diagnosis of small cell or neuroendocrine prostate cancer;
- Prior history of leukemia or Myelodysplastic Syndrome;
- Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study;
- Unmanageable urinary tract obstruction;
- Previous treatment with a systemic radionuclide:
- Dose Escalation: Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor;
- Cohort Expansion: Previous treatment with a systemic radionuclide, including Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor; Any previous PSMA targeted radionuclide therapy (including 177Lu and Actinium-225) is also excluded.
- Previous treatment with any systemic anti-cancer therapy (e.g. immunotherapy or biological therapy \[including monoclonal antibodies\]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone (LHRH), any other androgen deprivation therapy (ADT) or low dose corticosteroids.
- Dose Escalation: prior treatment with chemotherapy within 4 weeks of first administration of 67Cu-SAR-bisPSMA is also excluded.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- Stanford Cancer Institute — Stanford, California
- East Jefferson General Hospital — River Ridge, Louisiana
- BAMF Health — Grand Rapids, Michigan
- Mayo Clinic — Rochester, Minnesota
- Washington University School of Medicine at Barnes-Jewish Hospital — St Louis, Missouri
- XCancer — Omaha, Nebraska
- Weill Cornell Medicine at New York-Presbyterian — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.