NCT02361515

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostatic Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Moderate hypofractionated radiotherapy	Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.
RADIATION	Stereotactic radiotherapy	Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.

Timeline

• Start date: 2015-03-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2015-02-11
• Last updated: 2022-03-17

Locations

7 sites across 1 country: France