Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Prostatic Neoplasms, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.
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 |
What the registry record for NCT04689828 still lists
NCT04689828 is an interventional study that assigns participants to a tested intervention. The registered 469 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 507-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target.
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Prostatic Neoplasms
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 NCT04689828's enrollment target sits among peer trials
469 26th of 65 higher than 40 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms 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 Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
RECRUITING · Phase 3
-
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
RECRUITING · Phase 3
-
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
RECRUITING · Phase 3
-
Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
ACTIVE NOT RECRUITING · Phase 3
-
Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05256940 · 470 participants · NA
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
- NCT05458219 · 470 participants · Phase 1
A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
- NCT05850689 · 470 participants · Phase 3
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
- NCT05935384 · 470 participants
SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI