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Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk

Study acronym: SHORT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jan 24, 2024 to Apr 24, 2029v5
  2. Notable Primary completion date: Jan 24, 2018 to Jan 24, 2024 Start date: Nov 10, 2017 to Jan 24, 2018 · Completion date: Jan 24, 2020 to Apr 24, 2029v4 Show 2 more changesShow less
    • Start date: Nov 10, 2017 to Jan 24, 2018
    • Completion date: Jan 24, 2020 to Apr 24, 2029
  3. Minor Primary completion date changed from estimate of Nov 1, 2022 to Jan 24, 2018 Completion date: Jan 1, 2023 to Jan 24, 2020v3 Show 1 more changeShow less
    • Completion date: Jan 1, 2023 to Jan 24, 2020
  4. Notable Primary endpoint revisedv2 See this version in full on ClinicalTrials.gov ↗
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of 3 years. Prostatic stereotactic radiotherapy in 5 sessions is a therapeutic option currently delivered and described in multiple cohorts of patients with a tolerance comparable to normo-fractional treatments. This therapeutic scheme makes it possible to deliver a higher equivalent biological dose than during a treatment carried out with a conventional fractionation. The results with a follow-up of 9 years are extremely encouraging and do not show any excess toxicity compared to other irradiation techniques. They confirm that urinary and digestive toxicities are acceptable. All these studies did not involve pelvic irradiation. Several trials have also demonstrated the feasibility of normofractionated pelvic irradiation associated with hypofractionated prostatic irradiation using an integrated boost technique. The primary objective is to evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:To evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with: * a prostatic boost in brachytherapy with high dose rate (HDR) or * an integrated boost in stereotaxis (in case of contraindication to brachytherapy)
Trial Details
NCT Number NCT03417336
Lead Sponsor Centre Georges Francois Leclerc
Conditions To Evaluate the Rate of Digestive and Urinary Toxicity
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov