Trial Profile

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

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 17 Jun 2025

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At a glance

Drugs Lutetium (177Lu) vipivotide tetraxetan (Primary) ; Antiandrogens; Gallium (68Ga) gozetotide
Indications Adenocarcinoma; Prostate cancer
Focus Registrational; Therapeutic Use
Acronyms PSMAddition
Sponsors Novartis; Novartis Pharmaceuticals

02 Jun 2025 According to a Novartis Media Release, Data from this trial will be presented at an upcoming medical meeting and, based on FDA feedback, will be submitted for regulatory review in the second half of the year.
02 Jun 2025 Interim results presented in a Novartis Media Release.
02 Jun 2025 Primary endpoint (Radiographic Progression Free Survival (rPFS)) has been met, according to a Novartis media release.

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