Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Prostatic Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moderate Hypofractionated radiotherapy (62Gy)

20 fractions of 3.1Gy

Group Type ACTIVE_COMPARATOR

Moderate hypofractionated radiotherapy

Intervention Type RADIATION

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

Stereotactic radiotherapy (37.5Gy)

5 fractions of 7.5Gy)

Group Type EXPERIMENTAL

Stereotactic radiotherapy

Intervention Type RADIATION

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

Interventions

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Moderate hypofractionated radiotherapy

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

Intervention Type RADIATION

Stereotactic radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No