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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)

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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: 06 Aug 2026

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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

Most Recent Events

  • 31 Jul 2026 According to a Novartis Media Release, company announced the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer (mHSPC).
  • 21 Jul 2026 Results presented in Novartis media release.
  • 31 May 2026 Results presented in a Novartis Media Release

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