A Phase 2 interventional study of Surgery combined with IMRT-IGRT in Prostate Cancer and Prostate Adenocarcinoma, sponsored by Rennes University Hospital. Completed at 2 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by Rennes University Hospital · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 63 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
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Non-inclusion criteria:
Exclusion Criteria:
Procedure: Surgery combined with IMRT-IGRT
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.
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
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital