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A Phase 3, Open-Label, Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)

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Trial Profile

A Phase 3, Open-Label, Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Nov 2024

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At a glance

  • Drugs Lutetium-177 zadavotide guraxetan (Primary) ; Abiraterone; Dexamethasone; Enzalutamide; Prednisone; TLX591 companion diagnostic Telix Pharmaceuticals
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms SPLASH
  • Sponsors Eli Lilly and Company; POINT Biopharma

    • Most Recent Events

    • 30 Jan 2024 According to a Florida Cancer Specialists & Research Institute media release, Case presenter for a Phase 3, pivotal trial of PNT2002 radioligand therapy for metastatic prostate cancer will be featured at the ASCO 2024 Gastrointestinal (GI) Cancers Symposium.
    • 18 Dec 2023 According to a Lantheus Holdings and POINT Biopharma Global media release, companies expect additional, follow-up data in 2024 prior to the potential submission of a New Drug Application (NDA). Full results from this will be presented at a future medical congress.
    • 18 Dec 2023 Primary endpoint (Radiographic Progression Free Survival (rPFS)) has been met, according to a Lantheus Holdings and POINT Biopharma Global media release.

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