Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02361515
Other study ID # 2014-846
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date January 2020

Study information

Verified date March 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Moderate hypofractionated radiotherapy
Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.
Stereotactic radiotherapy
Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.

Locations

Country Name City State
France Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard Albi
France Centre Georges Francois Leclerc Dijon
France Institut Paoli Calmettes Marseille
France Site Hospitalier Nord Boulevard Jacques Monod Nantes
France Centre Hospitalier Lyon Sud Pierre-Bénite
France Institut de Cancérologie de la Loire St Etienne
France Groupe ONCORAD Clinique Pasteur Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 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. Follow-up at = 3 months after the radiotherapy and up to 3 years.
Secondary Survival rates without biological relapse in both arms. Survival rates without biological relapse (increase of the PSA (prostate-specific antigen) beyond nadir + 2 ng/ml, using Phoenix definition). 3 years.
Secondary Evaluation and comparison of the acute urinary and rectal toxicities in both arms. all toxicities will be listed using Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0. 3 months: evaluation at 3 months.
Secondary Evaluation and comparison of the sexual preservation rates in both arms. evaluation and comparison of the sexual preservation rates in both arms using International Index of Erectile Function (IIEF). 3 years.
Secondary Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches. 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. 3 years.
See also
  Status Clinical Trial Phase
Completed NCT01431391 - Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer Phase 2
Not yet recruiting NCT06015321 - An Open Label Phase II Study of First-Line Maintenance Enzalutamide Following Docetaxel Plus Androgen-Deprivation Therapy in Patients With Previously-Untreated, Metastatic, Castration-Naive Prostatic Adenocarcinoma Phase 2
Completed NCT03384199 - Dose Escalation Using Fiducial Markers in Image Guided Volumetric Modulated Arc Therapy to the Focal Lesion Micro Boost of Localized Prostate Cancer Phase 2
Completed NCT04063800 - Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI
Active, not recruiting NCT01542021 - Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer N/A
Recruiting NCT05498272 - Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With BRCA1/2 Gene Alterations Phase 2