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Hyaluronic Acid for Hypofractionated Prostate Radiotherapy (RPAH1)

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ClinicalTrials.gov Identifier: NCT02165020
Recruitment Status : Unknown
Verified October 2016 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Hyaluronic acid (Macrolane VRF 30®, Q-MED) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection
Study Start Date : November 2010
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.





Primary Outcome Measures :
  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. [ Time Frame: Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years. ]
    Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.


Secondary Outcome Measures :
  1. Number of patients with acute rectal toxicities of all grades and of grade ≥ 2. [ Time Frame: 3 years ]
    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.

  2. Tolerance of the HA injection [ Time Frame: 3 years ]
    The evaluation of the tolerance of the HA injection, as a measure of safety and tolerability (using the CTCAE v 4.0).

  3. Number of patients with acute and late toxicities, other than the rectal toxicities. [ Time Frame: 3 years ]
    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.

  4. 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. ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165020


Locations
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France
Hospices Civils de Lyon
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02165020    
Other Study ID Numbers: 2010-606
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Keywords provided by Hospices Civils de Lyon:
Prostate
Hypofractionated radiotherapy
Hyaluronic acid
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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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents