Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT04689828 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 469 participants
Start Date 2021-06-15
Est. Completion 2026-09-30
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 469 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04689828 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Massachusetts, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04689828?

The interventions under investigation include: 68Ga-PSMA-11 (DRUG), 177Lu-PSMA-617 (DRUG), ARDT (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04689828?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial