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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
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Apr 2024 to Mar 2026v9
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 140 to confirmed 130
    • Study sites: 5 to 12
    • Collaborators revised (8)
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Eligibility criteria shortened, about 49 wordsv6
  5. Study sites: 4 to 5v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 2 to 4v4
  2. Study sites: 1 to 2v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 23, 2020 to Apr 21, 2020
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
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
(from sponsor)		 Metastatic Hormone Naive Prostate Cancer
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov