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Study identifier: NCT03417336 Synced from ClinicalTrials.gov · July 29, 2026
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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

Condition: To Evaluate the Rate of Digestive and Urinary Toxicity  ·  Sponsor: Centre Georges Francois Leclerc

PhaseNA
Planned participants90
Who can joinMale, 18 Years to 85 Years
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Magalie QUIVRIN  ·  03.80.73.75.00  ·  mquivrin@cgfl.fr

Emilie REDERSTORFF  ·  03 45 34 81 16  ·  erederstorff@cgfl.fr

Always discuss trial participation with your own doctor first.

Locations (2)

Centre Georges François LeclercDijon, FranceRecruiting
CGFLDijon, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT03417336