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A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy

Trial Profile

A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy

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

Latest Information Update: 08 May 2025

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At a glance

  • Drugs ATL 101 Telix Pharmaceuticals (Primary) ; Hydrocortisone; J 591-radiolabelled; Ketoconazole
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Therapeutic Use

Most Recent Events

  • 30 Apr 2025 Planned End Date changed from 1 Dec 2025 to 1 May 2026.
  • 18 Feb 2023 Results assessing that 177Lu prolongs 18-month (mo) met-free survival (MFS) more than 111In in patients with high-risk non-metastatic castration-resistant prostate cancer, presented at the 2023 Genitourinary Cancers Symposium
  • 18 Feb 2023 Results assessing 177Lu prolongs 18-month (mo) met-free survival (MFS) more than 111In in pts with high risk, M0 CRPC when targeting PSMA via J591 in combo with keto and HC presented at the 2023 Genitourinary Cancers Symposium

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