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Hyaluronic Acid for Hypofractionated Prostate Radiotherapy (RPAH1)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Hyaluronic acid (Macrolane VRF 30®, Q-MED)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rectal toxicities after prostate hypofractionated radiotherapy

Arm Description

Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
The evaluation of the biochemical control

Full Information

First Posted
May 5, 2014
Last Updated
October 4, 2016
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02165020
Brief Title
Hyaluronic Acid for Hypofractionated Prostate Radiotherapy
Acronym
RPAH1
Official Title
Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rectal toxicities after prostate hypofractionated radiotherapy
Arm Type
Experimental
Arm Description
Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid (Macrolane VRF 30®, Q-MED)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.
Time Frame
Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years.
Secondary Outcome Measure Information:
Title
Number of patients with acute rectal toxicities of all grades and of grade ≥ 2.
Description
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.
Time Frame
3 years
Title
Tolerance of the HA injection
Description
The evaluation of the tolerance of the HA injection, as a measure of safety and tolerability (using the CTCAE v 4.0).
Time Frame
3 years
Title
Number of patients with acute and late toxicities, other than the rectal toxicities.
Description
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.
Time Frame
3 years
Title
The evaluation of the biochemical control
Time Frame
3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France

12. IPD Sharing Statement

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Hyaluronic Acid for Hypofractionated Prostate Radiotherapy

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