NCT06288113RecruitingPhase 2
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial
Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA STUDY)
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 5 Feb 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 27 Jan 2027
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT06288113
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Aug 2024 to the primary completion date, 27 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- Patient with creatinine clearance \< 50 mL/min
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.