Re-treatment with a radioactive drug for advanced prostate cancer
Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA STUDY)
This study is testing if giving a radioactive drug again can help men with advanced prostate cancer who did well on it before feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06288113 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of re-treatment with 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) who previously responded well to this therapy. The study aims to assess treatment efficacy, safety, and various survival outcomes after administering up to six additional cycles of the drug. Patients will be monitored for prostate-specific antigen (PSA) response, progression-free survival, and overall survival, along with quality of life assessments. The trial also includes exploratory objectives related to dosimetry in organs affected by the treatment.
Who should consider this trial
Good fit: Ideal candidates are men with metastatic castration-resistant prostate cancer who have previously shown a favorable response to 177Lu-PSMA-617 therapy.
Not a fit: Patients who have not previously responded to 177Lu-PSMA-617 therapy or have not completed the required prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival outcomes and disease response in patients with advanced prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches using 177Lu-PSMA-617, indicating potential for success in this re-treatment strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must have mCRPC * Patients must have received at least one regimen of chemotherapy for mCRPC * Patients must have received at least one androgen receptor signaling inhibitor (ARSI) * Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy * Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617 therapy defined as: * PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617 therapy AND * No new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy \[ADT\] is allowed). Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed * Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617 therapy, confirmed by a second measurement ≥ 3 weeks apart * Patients must meet PSMA PET/CT VISION criteria. PSMA PET/CT must have been completed within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy * White blood cells \> 2,500 cells/µL * Absolute neutrophil count \> 1,500 cells/µL * Hemoglobin \> 9.0 g/dL * Platelets \> 100,000 cells/µL * Patients must have the ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements Exclusion Criteria: * Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed * Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks * Patient with creatinine clearance \< 50 mL/min
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeremie Calais, MD — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Stephanie Lira
- Email: StephanieLira@mednet.ucla.edu
- Phone: 3102060596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.