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Study identifier: NCT04720157 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Active Not Recruiting

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)

Condition: Prostatic Neoplasms  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 3
Planned participants1140
Who can joinMale, 18 Years to 100 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (167)

Mayo Clinic - Arizona Mayo Clinic HospitalScottsdale, Arizona, United States
Mayo Clinic ArizonaScottsdale, Arizona, United States
University of California San Diego - Moores Cancer CenterLa Jolla, California, United States
VA Greater LA Healthcare SystemLos Angeles, California, United States
University of California LALos Angeles, California, United States
St. Joseph HospitalOrange, California, United States
Univ Cali Irvine ALS NeuromuscularOrange, California, United States
VA Palo Alto Health Care SystemPalo Alto, California, United States
Stanford University Medical CenterPalo Alto, California, United States
Sansum ClinicSanta Barbara, California, United States
Providence Saint Johns Health CtrSanta Monica, California, United States
Univ Of Color Anschutz Med CenterAurora, Colorado, United States

+ 155 more locations — full list on the registry record.

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