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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.
Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.
Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard
Albi, France
Centre Georges Francois Leclerc
Dijon, France
Institut Paoli Calmettes
Marseille, France
Site Hospitalier Nord Boulevard Jacques Monod
Nantes, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Institut de Cancérologie de la Loire
Saint-Etienne, France
Groupe ONCORAD Clinique Pasteur
Toulouse, France
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.