Hyaluronic Acid for Hypofractionated Prostate Radiotherapy

NCT ID: NCT02165020

Last Updated: 2016-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2017-05-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rectal toxicities after prostate hypofractionated radiotherapy

Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

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.
• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon

Lyon, , France

Countries

France

Other Identifiers

2010-606

Identifier Type: -

Identifier Source: org_study_id