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NCT03511664 · ClinicalTrials.gov registry record · Phase 3
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
A Phase 3 study of Prostate Cancer, sponsored by Endocyte.
- Completed
- Registry status
- Phase 3
- Development phase
- 861
- Enrollment target
- 20
- Study locations
NCT03511664: Completed Phase 3 study of Prostate Cancer, sponsored by Endocyte.
NCT03511664 is a Phase 3 study of Prostate Cancer that has completed, run by Endocyte. The registered enrollment target is 861 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03511664, a Phase 3 study of Prostate Cancer, has completed, sponsored by Endocyte.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 861 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of randomization to the date of radiographic disease progression based on the central review assessment per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause. Patients who were alive without radiographic progression at the analysis data cut-off were censored for rPFS at the time of their last evaluable radiographic assessment. Date of censoring for rPFS: 1)
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 |
What the finished NCT03511664 record still lists
NCT03511664 is an interventional study that assigns participants to a tested intervention. The registered 861 participants enrollment target is mid-sized for trials with a published cap, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (42% higher).
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.
NCT03511664 names 20 study sites across 13 states, led by California, Arizona, Indiana.
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.
What interventions are being tested in trial NCT03511664?
The interventions under investigation include: 177Lu-PSMA-617 (DRUG), Best supportive/best standard of care (OTHER).
Who is sponsoring clinical trial NCT03511664?
This trial is sponsored by Endocyte, which has 18 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03511664's enrollment target sits among peer trials
861 74th of 735 higher than 662 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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