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VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

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Trial Profile

VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2025

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At a glance

  • Drugs Lutetium (177Lu) vipivotide tetraxetan (Primary) ; Denosumab; Dexamethasone; Gallium (68Ga) gozetotide; Zoledronic acid
  • Indications Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms VISION
  • Sponsors Endocyte

Most Recent Events

  • 19 Sep 2025 According to a Novartis media release, company announced launch of Pulvic Intravenous Injection approval for castration-resistant prostate cancer (mCRPC) with prostate-specific membrane antigen (PSMA)-positive distant metastases in Japan based on based on the overseas phase III studies A12301/VISION and B12302/PSMAfore studies and progressive PSMA positivity in Japan.
  • 05 May 2025 According to a Telix Pharmaceuticals media release, based on this trial Illuccix (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in the Czech Republic by the SUKL.
  • 30 Apr 2025 According to a Telix Pharmaceuticals media release, announces that its prostate cancer PET Imaging agent Illuccix has been granted marketing authorization by Fimea for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. Illuccix's broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial.

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