Clinical Trial

In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

Study acronym: UpFrontPSMA
Active, Not Recruiting Phase 2
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Record status
This record was last updated July 11, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-04-09; most recent amendment 2025-07-08.
Status change: Recruiting → Active, Not Recruiting 2023-07-03
Status change: Not Yet Recruiting → Recruiting 2020-05-06
Trial Details
NCT Number NCT04343885
Lead Sponsor Peter MacCallum Cancer Centre, Australia
Collaborators: Movember Foundation, Prostate Cancer Research Alliance, United States Department of Defense, Advanced Accelerator Applications, Australia's Nuclear Science and Technology Organisation (ANSTO), Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Australasian Radiopharmaceutical Trials network (ARTnet), Centre for Biostatistics and Clinical Trials (BaCT)
Conditions Metastatic Hormone Naive Prostate Cancer
Enrollment 130 participants
Start Date 2020-04-21
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-07-11