Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid

Moderate Hypofractionated Radiotherapy (62 Gy in 20 Fractions of 3.1 Gy) Versus Stereotactic Radiotherapy (37.5 Gy in 5 Fractions of 7.5 Gy) With Hyaluronic Acid Injection Between the Prostate and the Rectum for Prostate Cancer of Low- to Intermediate Risk; RPAH2

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.

Inclusion Criteria:

• age superior or equal to 18 years and inferior to 80 years.
• patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
• prostate cancer histologically proven.
• performance index OMS (World Health Organization) of grade 0-2.
• indication of external beam radiotherapy validate by the medical commission of the institution.
• IPSS (International Prostate Symptom Score < 15/35 (without alpha-blocker).
• the signed consent form.

Exclusion Criteria:

• Rectal surgery antecedents.
• prostate resection less than 6 mois.
• Involvement of the seminal vesicles or of the capsule on MRI.
• patient who can't cooperate during the treatment.
• pelvic irradiation antecedents.
• antecedents of inflammatory intestinal pathologies.
• neoplasia.
• patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect).
• patients receiving anticoagulant treatment.
• other undergoing study that may interfere with the present study.
• patient under legal protection measure.
• hypersensitivity to hyaluronic acid.
• patient with auto-immune disease.
• patient receiving immunosuppressive medication.
• severe allergies.
• history of endocarditis.