Actively Recruiting
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-13
40
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have metastatic castration-resistant prostate cancer (mCRPC)
- Patients must have received at least one chemotherapy regimen for mCRPC
- Patients must have received at least one androgen receptor signaling inhibitor (ARSI)
- Patients must have completed at least 4 cycles of 177Lu-PSMA-617 therapy previously
- Patients must have had a PSA decline of 50% or more during the first 177Lu-PSMA-617 therapy
- No new prostate cancer therapy within two months after the first 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy is allowed)
- Patients must have a confirmed PSA increase after the first 177Lu-PSMA-617 therapy, with measurements at least 3 weeks apart
- Patients must meet PSMA PET/CT VISION criteria with imaging done within 8 weeks before re-treatment
- White blood cell count above 2,500 cells/μL
- Absolute neutrophil count above 1,500 cells/μL
- Hemoglobin level above 9.0 g/dL
- Platelet count above 100,000 cells/μL
- Ability to understand and sign informed consent and comply with study requirements
You will not qualify if you...
- Received new prostate cancer therapy within two months after completing the first 177Lu-PSMA-617 therapy, except first-generation androgen deprivation therapy
- Received myelosuppressive therapy or radionuclide therapy within the last 6 weeks
- Creatinine clearance below 50 mL/min
AI-Screening
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Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
S
Stephanie Lira
CONTACT
E
Ethan Lam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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