Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hypofractionated radiotherapy (62Gy) | Active Comparator | 20 fractions of 3.1Gy |
|
| Stereotactic radiotherapy (37.5Gy) | Experimental | 5 fractions of 7.5Gy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate hypofractionated radiotherapy | Radiation | Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Evaluation and comparison of the acute urinary and rectal toxicities in both arms. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard | Albi | 81000 | France | |||
| Centre Georges Francois Leclerc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32307017 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stereotactic radiotherapy | Radiation | Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy. |
|
all toxicities will be listed using Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0. |
| 3 months: evaluation at 3 months. |
| 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. |
| 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. |
| Dijon |
| 21079 |
| France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| Site Hospitalier Nord Boulevard Jacques Monod | Nantes | 44805 | France |
| Centre Hospitalier Lyon Sud | Pierre-BĂ©nite | 69495 | France |
| Institut de Cancérologie de la Loire | Saint-Etienne | 42270 | France |
| Groupe ONCORAD Clinique Pasteur | Toulouse | 31300 | France |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |