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Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy

Study acronym: F-Sharp
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 24, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Phase: Phase 1/2 to Not applicablev6 Show 4 more changesShow less
    • Primary completion date: Mar 31, 2022 to Mar 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 31, 2024 to Jul 31, 2026
    • Site details revised at 2 of 2 sites
  2. Notable Enrollment target: 24 to 50
    • Primary completion date: Mar 31, 2020 to Mar 31, 2022
    • Study sites: 1 to 2
    • Study completion date: Mar 31, 2021 to Mar 31, 2024
    v5
  3. Notable Primary completion date: Mar 31, 2019 to Mar 31, 2020
    • Study completion date: Mar 31, 2020 to Mar 31, 2021
    v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Phase: Not applicable to Phase 1/2v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This purpose of this study is to evaluate the safety and effectiveness of a technique called focal high-dose-rate (HDR) brachytherapy as treatment for prostate cancer that has come back in the prostate after prior radiotherapy. The study will examine the safety and efficacy of the treatment. The type of radiation that participants in this research will receive is targeted directly at the areas of the prostate where recurrent disease is evident, while avoiding treatment of the normal appearing prostate. This involves the placement of a radioactive material in the affected area of the prostate temporarily, where it remains for a short period of time, and then is subsequently removed using a minimally invasive technique called HDR Brachytherapy.
Trial Details
NCT Number NCT03312972
Lead Sponsor Loyola University
Conditions
(from sponsor)
Locally Recurrent Prostate Cancer
Related terms Neoplasms, Prostatic Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov