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Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 27, 2026 to Jan 27, 2027
    • Study completion date: Jan 27, 2027 to Jan 27, 2028
    v7
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 31, 2024 to Aug 1, 2024
    • Site details revised
    v5
  4. Start date: Jun 30, 2024 to Dec 31, 2024v4
  5. Start date: Apr 1, 2024 to Jun 30, 2024v3
  6. Secondary endpoints: details revised at 3 of 10 entriesv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.
Trial Details
NCT Number NCT06288113
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: Novartis Pharmaceuticals
Conditions
(from sponsor)		 Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov