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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
One injection of 3 to 10 cc of hyaluronic acid (Macrolane VRF 30®, Q-MED) introduced in the perirectal fat between the rectum and the prostate in connection with an ultrasound. The injection is performed under local anesthesia (with "Lidocaine") and ultrasound guidance, using a 16 gauge needle.
Hospices Civils de Lyon
Lyon, France
Number of patients with late rectal toxicities (> 3 months) 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.
Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.
Time frame: Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years.
Number of patients with acute rectal toxicities of all grades and of grade ≥ 2.
Number of patients with acute rectal toxicities of all grades and of grade ≥ 2 (using the CTCAE v 4.0), as a measure of safety and tolerability.
Time frame: 3 years
Tolerance of the HA injection
The evaluation of the tolerance of the HA injection, as a measure of safety and tolerability (using the CTCAE v 4.0).
Time frame: 3 years
Number of patients with acute and late toxicities, other than the rectal toxicities.
Number of patients with acute and late toxicities (using the CTCAE v 4.0), other than the rectal toxicities, as a measure of safety and tolerability.
Time frame: 3 years
The evaluation of the biochemical control
Time frame: 3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years.
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