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Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid (RPAH2)

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ClinicalTrials.gov Identifier: NCT02361515
Recruitment Status : Active, not recruiting
First Posted : February 11, 2015
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.

Ninety-six patients and 9 centers are included in the protocol.


Condition or disease Intervention/treatment Phase
Prostatic Adenocarcinoma Radiation: Moderate hypofractionated radiotherapy Radiation: Stereotactic radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Moderate Hypofractionated Radiotherapy (62 Gy in 20 Fractions of 3.1 Gy) Versus Stereotactic Radiotherapy (37.5 Gy in 5 Fractions of 7.5 Gy) With Hyaluronic Acid Injection Between the Prostate and the Rectum for Prostate Cancer of Low- to Intermediate Risk; RPAH2
Actual Study Start Date : March 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Moderate Hypofractionated radiotherapy (62Gy)
20 fractions of 3.1Gy
Radiation: Moderate hypofractionated radiotherapy
Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.

Experimental: Stereotactic radiotherapy (37.5Gy)
5 fractions of 7.5Gy)
Radiation: Stereotactic radiotherapy
Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.




Primary Outcome Measures :
  1. Number of patients with late urinary toxicities of grade ≥ 2 after moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and after stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy). [ Time Frame: Follow-up at ≥ 3 months after the radiotherapy and up to 3 years. ]
    Late urinary toxicities of grade ≥ 2 assessed using the Common Toxicity Criteria for Adverse Effects ( CTCAE) v 4.0 classification from 3 months to 3 years.


Secondary Outcome Measures :
  1. Survival rates without biological relapse in both arms. [ Time Frame: 3 years. ]
    Survival rates without biological relapse (increase of the PSA (prostate-specific antigen) beyond nadir + 2 ng/ml, using Phoenix definition).

  2. Evaluation and comparison of the acute urinary and rectal toxicities in both arms. [ Time Frame: 3 months: evaluation at 3 months. ]
    all toxicities will be listed using Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.

  3. Evaluation and comparison of the sexual preservation rates in both arms. [ Time Frame: 3 years. ]
    evaluation and comparison of the sexual preservation rates in both arms using International Index of Erectile Function (IIEF).

  4. Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches. [ Time Frame: 3 years. ]
    Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches, using Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0.



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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.
  • performance index OMS (World Health Organization) of grade 0-2.
  • indication of external beam radiotherapy validate by the medical commission of the institution.
  • IPSS (International Prostate Symptom Score < 15/35 (without alpha-blocker).
  • the signed consent form.

Exclusion Criteria:

  • Rectal surgery antecedents.
  • prostate resection less than 6 mois.
  • Involvement of the seminal vesicles or of the capsule on MRI.
  • patient who can't cooperate during the treatment.
  • pelvic irradiation antecedents.
  • antecedents of inflammatory intestinal pathologies.
  • neoplasia.
  • 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.
  • other undergoing study that may interfere with the present study.
  • patient under legal protection measure.
  • hypersensitivity to hyaluronic acid.
  • patient with auto-immune disease.
  • patient receiving immunosuppressive medication.
  • severe allergies.
  • history of endocarditis.

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): NCT02361515


Locations
France
Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard
Albi, France, 81000
Centre Georges Francois Leclerc
Dijon, France, 21079
Institut Paoli Calmettes
Marseille, France, 13009
Site Hospitalier Nord Boulevard Jacques Monod
Nantes, France, 44805
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Institut de Cancérologie de la Loire
St Etienne, France, 42270
Groupe ONCORAD Clinique Pasteur
Toulouse, France, 31300
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02361515     History of Changes
Other Study ID Numbers: 2014-846
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by Hospices Civils de Lyon:
Prostate
Hypofractionated radiotherapy
Stereotactic irradiation
Spacer
Rectal and bladder toxicities

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents