NCT06288113 Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial
| NCT ID | NCT06288113 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Castration-Resistant Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2027-01-27 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-08-01 with a primary completion date of 2027-01-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.
Eligibility 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
Contact & Investigator
Jeremie Calais, MD
PRINCIPAL INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06288113 clinical trial?
This trial is open to male participants only, studying Castration-Resistant Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06288113 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06288113 currently recruiting?
Yes, NCT06288113 is actively recruiting participants. Contact the research team at StephanieLira@mednet.ucla.edu for enrollment information.
Where is the NCT06288113 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06288113 clinical trial?
NCT06288113 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Jeremie Calais, MD at UCLA / Jonsson Comprehensive Cancer Center. The trial plans to enroll 40 participants.