177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (NCT04689828)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Rocky Mountain Cancer Centers — Denver, Colorado
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (72 Sites)
Showing the first 25 of 72 sites.
- Rocky Mountain Cancer Centers — Denver, Colorado
- University of Florida — Gainesville, Florida
- Tulane Uni Health Sciences Center — New Orleans, Louisiana
- Dana Farber Cancer Institute — Boston, Massachusetts
- Beth Israel Deaconess Med Ctr — Boston, Massachusetts
- WA Uni School Of Med — St Louis, Missouri
- Urology Cancer Center PC — Omaha, Nebraska
- Nebraska Cancer Specialists — Omaha, Nebraska
- NYU Laura and Isaac Perlmutter Cancer Center — New York, New York
- Mount Sinai Hosp Med School — New York, New York
- Memorial Sloan Kettering Cancer Ctr — New York, New York
- Duke Univ Medical Center — Durham, North Carolina
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- Tennessee Oncology — Nashville, Tennessee
- Uni Of TX MD Anderson Cancer Cntr — Houston, Texas
- Utah Cancer Specialists — Salt Lake City, Utah
- Virginia Oncology Associates — Norfolk, Virginia
- Onco Hemato Asso of SW Virginia — Roanoke, Virginia
- Seattle Cancer Care Alliance — Seattle, Washington
- Medical College Of Wisconsin — Milwaukee, Wisconsin
- Novartis Investigative Site — Innsbruck, Tyrol
- Novartis Investigative Site — Linz,
- Novartis Investigative Site — Vienna,
- Novartis Investigative Site — Roeselare, West-Vlaanderen
- Novartis Investigative Site — Brussels,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.