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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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).
- 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.
- 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).
- 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.
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
|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|