Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional Results available

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

ClinicalTrials.gov ID: NCT04689828

Public ClinicalTrials.gov record NCT04689828. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 9:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-Directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04689828
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
469 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 15, 2021 (Actual)
Primary completion
Oct 2, 2022 (Actual)
Completion
Sep 10, 2026 (Estimated)
Last update posted
Sep 11, 2026

2021 – 2026

United States locations

U.S. sites
20
U.S. states
15
U.S. cities
16
Facility City State ZIP Site status
Rocky Mountain Cancer Centers Denver Colorado 80218 —
University of Florida Gainesville Florida 32610 —
Tulane Uni Health Sciences Center New Orleans Louisiana 70112 —
Dana Farber Cancer Institute Boston Massachusetts 02115 —
Beth Israel Deaconess Med Ctr Boston Massachusetts 02215 —
WA Uni School Of Med St Louis Missouri 63110 —
Urology Cancer Center PC Omaha Nebraska 68130 —
Nebraska Cancer Specialists Omaha Nebraska 68154 —
NYU Laura and Isaac Perlmutter Cancer Center New York New York 10016 —
Mount Sinai Hosp Med School New York New York 10029 —
Memorial Sloan Kettering Cancer Ctr New York New York 10065 —
Duke Univ Medical Center Durham North Carolina 27710 —
The Ohio State University Comprehensive Cancer Center Columbus Ohio 43221 —
Tennessee Oncology Nashville Tennessee 37203 —
Uni Of TX MD Anderson Cancer Cntr Houston Texas 77030 —
Utah Cancer Specialists Salt Lake City Utah 84106 —
Virginia Oncology Associates Norfolk Virginia 23502 —
Onco Hemato Asso of SW Virginia Roanoke Virginia 24014 —
Seattle Cancer Care Alliance Seattle Washington 98109 —
Medical College Of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 52 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04689828, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 11, 2026 · Synced Oct 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04689828 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →