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: * pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the radiation target volume to the prostate only (and not to irradiate the SV); * a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).
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: * Limiting the target volume to prostate only by removing seminal vesicles at the time of lymph node dissection, * Using a technique of high-precision radiation combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT). 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
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.
Service d'Urologie - Hôpital de Pontchaillou
Rennes, France
Centre Eugène Marquis - CRLCC
Rennes, France
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.
Time frame: between 6 months and 3 years
Dose received by the rectum and the bladder with and without seminal vesicles irradiation
Assessed using a dose-volume histogram
Time frame: Before treatment
Quality of life
Assessed with EORTC questionnaires (QLQ-C30, QLQ-PR25)
Time frame: 3 years
Erectile troubles
Assessed with erectile troubles questionnaire (IIEF-5)
Time frame: 3 years
Onset of biological signs evocating a recidive
Assessed with PSA levels
Time frame: 3 years
Onset of clinical signs evocating a recidive
Time frame: 3 years
Specific and global survival
Time frame: 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.
Time frame: 6 months
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