Hyaluronic Acid for Hypofractionated Prostate Radiotherapy

NCT02165020 | Unknown Phase 2 DMC

• 1 other identifier: 2010-606
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate; Hypofractionated radiotherapy; Hyaluronic acid; Spacer; Rectum toxicity; Rectal toxicities after hypofractionated irradiation and injection of hyaluronic acid in patients with low- to intermediate-risk Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of patients with acute rectal toxicities of all grades and of grade ≥ 2.

  3 years

• Tolerance of the HA injection

  3 years

• Number of patients with acute and late toxicities, other than the rectal toxicities.

  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.

Study Arms (1)

Rectal toxicities after prostate hypofractionated radiotherapy

EXPERIMENTAL

Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid

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

Interventions

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

Rectal toxicities after prostate hypofractionated radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69002, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: June 17, 2014
• Study Start: November 1, 2010
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 5, 2016

Record last verified: 2016-10

Locations

FR (1)