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Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
NCT03511664 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone.
Conditions Studied
Interventions
- DRUG 177Lu-PSMA-617
- OTHER Best supportive/best standard of care
Study Locations (20)
California
- VA Greater Los Angeles Healthcare System — Los Angeles
- University of California Los Angeles, Nuclear Medicine — Los Angeles
- Stanford Cancer Institute — Palo Alto
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
Arizona
- HonorHealth Research Institute — Scottsdale
- University of Arizona Cancer Center — Tucson
Indiana
- Parkview Research Center — Fort Wayne
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis
Iowa
- University of Iowa Hospitals and Clinics — Iowa City
- Iowa City VA Medical Center — Iowa City
Maryland
- University of Maryland Greenebaum Cancer Center — Baltimore
- Chesapeake Urology Associates (CUA) P.A. — Towson
Colorado
- University of Colorado Hospital — Aurora
Connecticut
- Yale Cancer Center — New Haven
District of Columbia
- Washington DC VA Medical Center, Nuclear Medicine Service — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 861 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2023-12-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03511664
The ClinicalTrials.gov registry entry for NCT03511664 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 861 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endocyte, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions — of which 177Lu-PSMA-617 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03511664 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Arizona, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03511664 about?
NCT03511664 is a clinical study titled "Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer". The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) wh...
What is the current status of trial NCT03511664?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 861 participants. The study started on 2018-05-29. Estimated completion is 2023-12-14.
What conditions does trial NCT03511664 study?
This clinical trial studies the following conditions: Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03511664?
The interventions under investigation include: 177Lu-PSMA-617 (DRUG), Best supportive/best standard of care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03511664?
This trial is sponsored by Endocyte, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03511664 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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