An interventional study of Moderate hypofractionated radiotherapy and Stereotactic radiotherapy in Prostatic Adenocarcinoma, sponsored by Hospices Civils de Lyon. Completed at 7 sites in France. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.
Ninety-six patients and 9 centers are included in the protocol.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 96 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20 fractions of 3.1Gy
Radiation: Moderate hypofractionated radiotherapy
5 fractions of 7.5Gy)
Radiation: Stereotactic radiotherapy
Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.
Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.
Number of patients with late urinary toxicities of grade ≥ 2 after moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and after stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy).
Late urinary toxicities of grade ≥ 2 assessed using the Common Toxicity Criteria for Adverse Effects ( CTCAE) v 4.0 classification from 3 months to 3 years.
Time frame: Follow-up at ≥ 3 months after the radiotherapy and up to 3 years.
Survival rates without biological relapse in both arms.
Survival rates without biological relapse (increase of the PSA (prostate-specific antigen) beyond nadir + 2 ng/ml, using Phoenix definition).
Time frame: 3 years.
Evaluation and comparison of the acute urinary and rectal toxicities in both arms.
all toxicities will be listed using Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.
Time frame: 3 months: evaluation at 3 months.
Evaluation and comparison of the sexual preservation rates in both arms.
evaluation and comparison of the sexual preservation rates in both arms using International Index of Erectile Function (IIEF).
Time frame: 3 years.
Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches.
Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches, using Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0.
Time frame: 3 years.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon