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| ID | Type | Description | Link |
|---|---|---|---|
| LOC/09-07 | Other Identifier | Rennes University Hospital | |
| CIC0203/128 | Other Identifier | Rennes Clinical Research Center |
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| Name | Class |
|---|---|
| Center Eugene Marquis | OTHER |
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Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In the aim of lowering the toxicity, the treatment in this study will associate:
This study targets non metastatic prostatic locally-advanced adenocarcinomas which are at high risk of both local progression and metastases. The standard treatment of these tumours associates external beam radiation therapy (EBRT) and 3 years of androgen deprivation (AD) with LH-RH analogue. In the absence of AD and mainly when prostate specific antigen (PSA) is >10 ng/ml, several randomized studies have shown that high doses of EBRT increase biochemical control. Nevertheless, escalating the doses of radiation significantly increases the risk of rectal and/or urinary toxicities. In order to lower the toxicity of irradiation in locally-advanced prostate cancers, and to improve the quality of life of patients, this study aims at decreasing the volume of irradiated healthy tissues. To carry out this objective, we will use a double strategy:
Based on the literature, we may assume a toxicity rate of 30% during the three years of hormonotherapy with standard treatment (i.e. without removing seminal vesicles). We make the hypothesis of a 20% absolute reduction of toxicity with our protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery combined with IMRT-IGRT | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery combined with IMRT-IGRT | Procedure | Patients will have surgery consisting in extensive pelvic dissection and ablation of seminal vesicles. Surgery will be followed by prolonged hormonotherapy (3 years) associated, after 2 months, with prostatic only irradiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of bladder and/or rectal grade ≥2 toxicity (late toxicity) | Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed between 6 months and 3 years after the beginning of the radiotherapy. | between 6 months and 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dose received by the rectum and the bladder with and without seminal vesicles irradiation | Assessed using a dose-volume histogram | Before treatment |
| Quality of life | Assessed with EORTC questionnaires (QLQ-C30, QLQ-PR25) |
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Inclusion Criteria:
Non-inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud DE CREVOISIER, MD, PhD | Rennes CRLCC Eugène Marquis | Principal Investigator |
| Sebastien VINCENDEAU, MD | Rennes University Hospital | Study Director |
| Eric BELLISSANT, MD, PhD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Urologie - Hôpital de Pontchaillou | Rennes | 35033 | France | |||
| Centre Eugène Marquis - CRLCC |
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| 3 years |
| Erectile troubles | Assessed with erectile troubles questionnaire (IIEF-5) | 3 years |
| Onset of biological signs evocating a recidive | Assessed with PSA levels | 3 years |
| Onset of clinical signs evocating a recidive | 3 years |
| Specific and global survival | 3 years |
| Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) (early toxicity) | Rate of late bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed 6 months after the beginning of the radiotherapy. | 6 months |
| Rennes |
| 35042 |
| France |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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