This trial is active, not recruiting.

Conditions prostate cancer, prostate adenocarcinoma
Treatment surgery combined with imrt-igrt
Phase phase 2
Sponsor Rennes University Hospital
Collaborator Center Eugene Marquis
Start date June 2010
End date June 2018
Trial size 65 participants
Trial identifier NCT01148069, CIC0203/128, ID RCB 2009-A01336-51, LOC/09-07


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.

Primary Outcomes

Rate of bladder and/or rectal grade ≥2 toxicity (late toxicity)
time frame: between 6 months and 3 years

Secondary Outcomes

Dose received by the rectum and the bladder with and without seminal vesicles irradiation
time frame: Before treatment
Quality of life
time frame: 3 years
Erectile troubles
time frame: 3 years
Onset of biological signs evocating a recidive
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)
time frame: 6 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Age > 18, - Prostate adenocarcinoma (histologically proven), - Locally-advanced (T3a or Gleason > 7 or PSA ≥ 20 ng/mL), - Distal half of seminal vesicles unaffected on MRI, - Non metastatic cancer: negative extension assessment (on prostatic and pelvic MRI and bone scintigraphy), - Radiotherapy and hormonotherapy indication, - Medical insurance affiliation, - Written informed consent. Non-inclusion criteria: - Co-morbidity or medical history contraindicating surgery (pelvic lymphadenectomy and seminal vesicle ablation), - Contraindication to pelvic irradiation, - Hip prosthesis, - History of cancer for the last 5 years (except baso-cellular epithelioma), - History of pelvic irradiation, - Person deprived of freedom or under guardianship, - Participation in another biomedical research. Exclusion Criteria: - Surgery showing lymph nodes involvement (pelvic radiation indication) - Surgery without ablation of seminal vesicles - Surgery with positive margins in seminal vesicles

Additional Information

Official title Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers
Principal investigator Renaud DE CREVOISIER, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Rennes University Hospital.