Hyaluronic Acid for Hypofractionated Prostate Radiotherapy

Prostate Cancer Clinical Trial

— RPAH1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02165020
• Other study ID #: 2010-606
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 5, 2014
• Last updated: October 4, 2016
• Start date: November 2010
• Est. completion date: May 2017

Study information

• Verified date: October 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	The evaluation of the biochemical control		3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years.	No

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