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ACTIVE NOT RECRUITING Phase 3

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

NCT04720157 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate cancer (mHSPC). In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study. As of 31-Jan-2024, 1144 participants were enrolled in 20 countries.

Conditions Studied

Interventions

  • DRUG ADT
  • DRUG 68Ga-PSMA-11
  • DRUG 177Lu-PSMA-617
  • DRUG ARDT

Study Locations (20)

California

  • University of California San Diego - Moores Cancer Center — La Jolla
  • VA Greater LA Healthcare System — Los Angeles
  • University of California LA — Los Angeles
  • St. Joseph Hospital — Orange
  • Univ Cali Irvine ALS Neuromuscular — Orange
  • VA Palo Alto Health Care System — Palo Alto
  • Stanford University Medical Center — Palo Alto
  • Sansum Clinic — Santa Barbara
  • Providence Saint Johns Health Ctr — Santa Monica

Florida

  • Mayo Clinic Jacksonville — Jacksonville
  • Cancer Specialists of North Florida — Jacksonville
  • University Of Miami — Miami
  • Miami Cancer Institute at Bapt — Miami

Arizona

  • Mayo Clinic - Arizona Mayo Clinic Hospital — Scottsdale
  • Mayo Clinic Arizona — Scottsdale

Colorado

  • Univ Of Color Anschutz Med Center — Aurora
  • Rocky Mountain Cancer Centers — Denver

District of Columbia

  • Georgetown University-Lombardi Cancer Center — Washington D.C.
  • VA Medical Center — Washington D.C.

Connecticut

  • Hartford Hospital — Hartford

Trial Details

FieldValue
Enrollment Target 1,145 participants
Start Date 2021-06-09
Est. Completion 2027-02-11
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 NCT04720157

The ClinicalTrials.gov registry entry for NCT04720157 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 1,145 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 4 interventions — of which ADT 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: NCT04720157 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT04720157 about?

NCT04720157 is a clinical study titled "An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)". The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate cancer (mHSPC). In this study, the SoC is defined as a combination of Androg...

What is the current status of trial NCT04720157?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,145 participants. The study started on 2021-06-09. Estimated completion is 2027-02-11.

What conditions does trial NCT04720157 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 NCT04720157?

The interventions under investigation include: ADT (DRUG), 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 NCT04720157?

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 NCT04720157 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. 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