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A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

Study acronym: PRODIGY-1
StatusNot Yet Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Jun 15, 2028 to Mar 2033
    • Start date: Mar 1, 2025 to Mar 2028
    • Study completion date: Jun 15, 2032 to Mar 2034
    v6
  2. Start date: Jan 29, 2024 to Mar 1, 2025v5
  3. Start date: Sep 15, 2023 to Jan 29, 2024v4
  4. Start date: Jun 15, 2023 to Sep 15, 2023v3
  5. Primary endpoints revised (3)
    • Interventions: 177Lu-PSMA-I&T (Drug) to 177Lu-PSMA-I&T - escalating renal absorbed dose (Drug), 177Lu-PSMA-I&T - recommended phase 2 regime (Drug)
    • Secondary endpoints expanded, about 40 words
    • Study arms: 1 to 5
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to study a personalized regime of lutetium-177 (177Lu) prostate-specific membrane antigen (PSMA) radiopharmaceutical therapy (RPT) in patients with progressive and/or symptomatic, inoperable PSMA-expressing cancers of prostatic or other origins. The main questions it aims to answer are: * To establish a dosimetry-based, personalized regime of 177Lu-PSMA * To report on the efficacy of personalized 177Lu-PSMA Participants (stratified by risk factors of toxicity) will receive up to 6 cycles of a personalized activity of 177Lu-PSMA based on renal dosimetry. In the phase 1, the prescribed absorbed dose to the kidney will be escalated, to determine the regime that will be administered in the phase 2. The best response within 12 months after the first cycle will be assessed. Salvage treatment of 3 cycles may be offered to responders after re-progression.
Trial Details
NCT Number NCT05896371
Lead Sponsor CHU de Quebec-Universite Laval
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions
(from sponsor)		 Cancer, Prostate Cancer, Metastatic Cancer, Metastatic Prostate Cancer
Related terms Neoplasm Metastasis, Neoplasms, Prostatic Neoplasms
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov