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Completed

NCT Number: NCT02361515

Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid

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.

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Key information

Conditions

Prostatic Adenocarcinoma

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard, Albi, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moderate hypofractionated radiotherapy

Radiation

Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.

Stereotactic radiotherapy

Radiation

Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: RPAH2

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2015
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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