Spots Global Cancer Trial Database for Hyaluronic Acid for Hypofractionated Prostate Radiotherapy

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Trial Identification

Brief Title: Hyaluronic Acid for Hypofractionated Prostate Radiotherapy

Official Title: Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection

Study ID: NCT02165020

Conditions

Prostate Cancer

Interventions

Hyaluronic acid (Macrolane VRF 30®, Q-MED)

Study Description

Brief Summary: The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico classification are included in the present protocol. The main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.

Detailed Description: