Hyaluronic Acid for Hypofractionated Prostate Radiotherapy
- Conditions
- Prostate Cancer
- Interventions
- Device: Hyaluronic acid (Macrolane VRF 30®, Q-MED)
- Registration Number
- NCT02165020
- Lead Sponsor
- Hospices Civils de Lyon
- 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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 36
- 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.
- life expectancy superior to 10 years.
- Karnofsky performance status ≥ 60% (performance status ECOG 0-2).
- the patient has to be the beneficiary of a social security system or other insurance (order n° 2006-477 from April 26th 2006).
- the signed consent form.
- age inferior to 18 years and ≥ 80 years;
- history of rectal surgery;
- patient who can't cooperate during the treatment;
- history of pelvic irradiation;
- history of inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
- other current neoplasia or history of neoplasia dating from less than 5 months, excepting basal-cell carcinomas;
- 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 or PLAVIX;
- other undergoing study that may interfere with the present study;
- patient under legal protection measure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rectal toxicities after prostate hypofractionated radiotherapy Hyaluronic acid (Macrolane VRF 30®, Q-MED) Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid
- Primary Outcome Measures
Name Time Method 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. Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years. Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.
- Secondary Outcome Measures
Name Time Method Number of patients with acute rectal toxicities of all grades and of grade ≥ 2. 3 years 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.
Number of patients with acute and late toxicities, other than the rectal toxicities. 3 years 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.
Tolerance of the HA injection 3 years The evaluation of the tolerance of the HA injection, as a measure of safety and tolerability (using the CTCAE v 4.0).
The evaluation of the biochemical control 3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years.
Trial Locations
- Locations (1)
Hospices Civils de Lyon
🇫🇷Lyon, France