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Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer

Study acronym: PROMPT
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Record History

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  1. Notable Primary completion date: Dec 15, 2023 to Dec 15, 2026
    • Study completion date: Dec 15, 2025 to Dec 15, 2027
    • Site contacts updated at 2 of 2 sites
    • Collaborator revised
    v3
  2. Notable Lead sponsor: Luis Souhami to McGill University Health Centre/Research Institute of the McGill University Health Centrev2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prostate cancer is the second most common cancer among Canadian men of which approximately 20-30% present with high-risk tumour characteristic. Although surgery can be curative in patients evidencing pathological high-risk disease (extracapsular extension, seminal vesicle involvement, positive surgical margins), a large proportion will develop biochemical failure within years from the surgical procedure. The failure rate is even more pronounced in those patients that present with high prostate specific antigen (PSA) levels, pT3 disease, positive margins and Gleason score ≥8 with an estimated 75% failure rate at 10 years. Post-operative radiotherapy (RT) has been shown in three randomized trials to significantly decrease the biochemical failure rate and in one of the trials a survival benefit was also seen with the addition of post-operative RT and is considered by many investigators standard therapy in patients with pathological high-risks factors even in absence of biochemical failure.
Trial Details
NCT Number NCT04249154
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Tolmar Inc.
Conditions
(from sponsor)
Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov