A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer (NCT05079698)
🩺 Plain-English Summary (8th-Grade Level)
The researchers are doing this study to find out whether giving 177Lu-PSMA-617 followed by a type of radiation therapy called SBRT (stereotactic body radiation therapy) is a safe treatment for your cancer. The study agent has been shown to target tumor cells, and the researchers think that adding 177Lu-PSMA-617 to SBRT may prevent or delay the cancer from continuing to spread.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (28 items) and avoid the listed exclusions (23 items).
Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
📋 "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:
- Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology not consistent with prostate adenocarcinoma
- Patients with documented castration resistant prostate cancer (CRPC)
- Patients with a PSMA scan within 2 months of enrollment that do not demonstrate metastatic lesions or demonstrate more than 5 discrete metastatic lesions
- Patients with PSMA negative metastatic lesions or with a mixture of PSMA avid and PSMA negative disease
- Patients with metastatic lesions not amenable to SBRT or treatment of which using a 9 Gy x 3 regimen would result in exceeding nationally accepted or institutional dose limits for nearby organs at risk
- Patients with previous radiation therapy for oligometastatic disease are still eligible
- Patients with prior radiotherapy to \> 25% of the skeleton or prior exposure to prior 223Radium, 89Strontium or 153Samarium containing compounds
- Patients with spinal cord compression, impending spinal cord compression, or parenchymal brain metastases (patients with epidural disease without cord compression are eligible)
- History of a prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessments
- Patients with known or suspected history of grade II or higher chronic kidney disease (CKD)
- Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
- Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, 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.