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NCT04689828 · ClinicalTrials.gov registry record · Phase 3
177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
A Phase 3 study of Prostatic Neoplasms, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 469
- Enrollment target
- 20
- Study locations
NCT04689828 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 469 participants, roughly in line with the 507-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target. The trial reports 20 study locations across 15 states.
The verdict
NCT04689828, a Phase 3 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 469 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether 177Lu-PSMA-617 improves the Radiographic progression-free survival (rPFS) or Overall Survival (OS) compared to a change in Androgen receptor-directed therapy (ARDT) in metastatic castrate resistant prostate cancer (mCRPC) participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings. 469 participants were randomized (235 in the 177Lu-PSMA-617 group and 234 in the ARDT group.
Conditions Studied
Interventions
- DRUG 68Ga-PSMA-11
- DRUG 177Lu-PSMA-617
- DRUG ARDT
Study Locations (20)
New York
- NYU Laura and Isaac Perlmutter Cancer Center - New York
- Mount Sinai Hosp Med School - New York
- Memorial Sloan Kettering Cancer Ctr - New York
Massachusetts
- Dana Farber Cancer Institute - Boston
- Beth Israel Deaconess Med Ctr - Boston
Nebraska
- Urology Cancer Center PC - Omaha
- Nebraska Cancer Specialists - Omaha
Virginia
- Virginia Oncology Associates - Norfolk
- Onco Hemato Asso of SW Virginia - Roanoke
Colorado
- Rocky Mountain Cancer Centers - Denver
Florida
- University of Florida - Gainesville
Louisiana
- Tulane Uni Health Sciences Center - New Orleans
Missouri
- WA Uni School Of Med - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 469 participants |
| Start Date | 2021-06-15 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04689828
The ClinicalTrials.gov registry entry for NCT04689828 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 469 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 507-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which 68Ga-PSMA-11 is the first listed.
NCT04689828 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New York, Massachusetts, Nebraska.
Frequently Asked Questions
What is clinical trial NCT04689828 about?
NCT04689828 is a clinical study titled "177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer". The purpose of this study is to determine whether 177Lu-PSMA-617 improves the Radiographic progression-free survival (rPFS) or Overall Survival (OS) compared to a change in Androgen receptor-directed therapy (ARDT) in metastatic castrate resistant prostate cancer (mCRPC) participants that were previ...
What is the current status of trial NCT04689828?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 469 participants. The study started on 2021-06-15. Estimated completion is 2026-09-30.
What conditions does trial NCT04689828 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT04689828?
The interventions under investigation include: 68Ga-PSMA-11 (DRUG), 177Lu-PSMA-617 (DRUG), ARDT (DRUG).
Who is sponsoring clinical trial NCT04689828?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04689828 being conducted?
This trial has 20 study locations across Colorado, Florida, Louisiana, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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