Hyaluronic Acid for Hypofractionated Prostate Radiotherapy (RPAH1)

Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection

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 Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Hyaluronic acid (Macrolane VRF 30®, Q-MED)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69002
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rectal toxicities after prostate hypofractionated radiotherapy; Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	3 years
The evaluation of the biochemical control		3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Prostate; Hyaluronic acid; Hypofractionated radiotherapy; Spacer; Rectum toxicity; Rectal toxicities after hypofractionated irradiation and injection of hyaluronic acid in patients with low- to intermediate-risk Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 2010-606