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NCT04720157 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Prostatic Neoplasms, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 1,145
- Enrollment target
- 20
- Study locations
NCT04720157 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 1,145 participants, above the 497-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (130% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT04720157, 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
- 1,145 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 1,145 participants |
| Start Date | 2021-06-09 |
| Est. Completion | 2027-02-11 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,145 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 497-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (130% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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.
NCT04720157 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.
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.
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).
Who is sponsoring clinical trial NCT04720157?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.