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Hyaluronic Acid for Hypofractionated Prostate Radiotherapy

NCT02165020 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-10-05

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02165020 on ClinicalTrials.gov