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24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer

Study acronym: PRO-FAST
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Secondary endpoints revised (12) Eligibility criteria shortened, about 3 words · Study description expanded, about 1 wordv4 Show 2 more changesShow less
    • Eligibility criteria shortened, about 3 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Start date changed from estimate of Nov 2023 to Nov 8, 2023v3
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 2023 to Nov 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Jul 2023 to Nov 2023
    • Site details revised
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients with prostate cancer who are candidates for stereotactic radiotherapy to the prostate and seminal vesicles will undergo staging exams, which will include prostate specific membrane antigen (PSMA) positron emission tomography-computed tomography (PET-CT). If the PET scan is negative and the uroflowmetry is acceptable, the patients will perform the treatment, after fiducial implantation, simulation CT and magnetic resonance (MR), in a single fraction, delivered with a high-dose-rate (HDR)-like urethral sparing technique. In 70 patients, acute and late toxicity, biochemical control, overall survival, cancer specific-survival, and quality of life (through specific questionnaires) will be evaluated.
Trial Details
NCT Number NCT05936736
Lead Sponsor IRCCS San Raffaele
Conditions Localized Prostate Carcinoma
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov