Clinical trial NCT02361515: Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Adenocarcinoma
Keywords: Prostate
Hypofractionated radiotherapy
Stereotactic irradiation
Spacer
Rectal and bladder toxicities
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: 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).
timeFrame: Follow-up at ≥ 3 months after the radiotherapy and up to 3 years.
Secondary outcomes:
measure: Survival rates without biological relapse in both arms.
timeFrame: 3 years.
measure: Evaluation and comparison of the acute urinary and rectal toxicities in both arms.
timeFrame: 3 months: evaluation at 3 months.
measure: Evaluation and comparison of the sexual preservation rates in both arms.
timeFrame: 3 years.
measure: Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches.
timeFrame: 3 years.
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: Site Hospitalier Nord Boulevard Jacques Monod
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: St Etienne
country: France
facility: Institut de Cancérologie de la Loire
city: Toulouse
country: France
facility: Groupe ONCORAD Clinique Pasteur
Study officials:
References:
citation: Jmour O, Benna M, Champagnol P, Ben Mrad M, Hamrouni A, Obeid L, Lahmamssi C, Bousarsar A, Vial N, Rehailia-Blanchard A, Sotton S, Lan M, Langrand-Escure J, Vallard A, Magne N. CBCT evaluation of inter- and intra-fraction motions during prostate stereotactic body radiotherapy: a technical note. Radiat Oncol. 2020 Apr 19;15(1):85. doi: 10.1186/s13014-020-01534-2.