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NCT04647526 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment
A Phase 3 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
- 20
- Study locations
NCT04647526: Active Phase 3 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company.
NCT04647526 is a Phase 3 study of Metastatic Castration-Resistant Prostate Cancer that is active but no longer recruiting, run by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company. The registered enrollment target is 455 participants, above the 191-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (138% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04647526, a Phase 3 study of Metastatic Castration-Resistant Prostate Cancer, is active but no longer recruiting, sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of \[Lu-177\]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).
Primary Outcome
* rPFS, as assessed by blinded independent central review (BICR), is the time from the randomization date to progression on soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or confirmed progression on bone lesions by Prostate Cancer Working Group 3 (PCWG3) criteria, or death from any cause. * The date of disease progression is the date of the scan for the first objectively documented progressive disease (PD) per RECIST v1.1 or PCWG3. PD is defined as a ≥20%
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG [Lu-177]-PNT2002
Study Locations (20)
California
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute - Los Angeles
- VA Greater Los Angeles Healthcare System - Los Angeles
- University of California Los Angeles, Nuclear Medicine Clinic - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- UC Irvine Chao Family Comprehensive Cancer Center - Orange
- Stanford Cancer Institute - Palo Alto
Missouri
- VA St. Louis Health Care System - St Louis
- Saint Louis University Hospital - St Louis
- Washington University School of Medicine - St Louis
Maryland
- University of Maryland Greenebaum Cancer Center - Baltimore
- Chesapeake Urology Associates (CUA) P.A. - Towson
Michigan
- University of Michigan Hospitals - Ann Arbor
- Karmanos Cancer Center - Detroit
Arizona
- Arizona Institute of Urology (AIU) - Tucson - Tucson
Colorado
- University of Colorado Hospital - Aurora
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
What the registry record for NCT04647526 still lists
NCT04647526 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (138% higher).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Enzalutamide is the first listed.
NCT04647526 names 20 study sites across 11 states, led by California, Missouri, Maryland.
Frequently Asked Questions
What is clinical trial NCT04647526 about?
NCT04647526 is a clinical study titled "Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment". The purpose of this study is to evaluate the efficacy and safety of \[Lu-177\]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).
What is the current status of trial NCT04647526?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2021-02-25. Estimated completion is 2028-03.
What conditions does trial NCT04647526 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT04647526?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), [Lu-177]-PNT2002 (DRUG).
Who is sponsoring clinical trial NCT04647526?
This trial is sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04647526 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Castration-Resistant Prostate Cancer
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 NCT04647526's enrollment target sits among peer trials
455 8th of 69 higher than 62 of 69 other Metastatic Castration-Resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
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