Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers
18 Years
N/A
Male
Prostate Cancer, Prostate Adenocarcinoma
Trial Information
Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of bladder and/or rectal grade ≥2 toxicity (late toxicity)
Outcome Description:
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.
Outcome Time Frame:
between 6 months and 3 years
Safety Issue:
Yes
Principal Investigator
Renaud DE CREVOISIER, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rennes CRLCC Eugène Marquis
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
ID RCB 2009-A01336-51
NCT ID:
NCT01148069
Start Date:
June 2010
Completion Date:
September 2015
Related Keywords:
- Prostate Cancer
- Prostate Adenocarcinoma
- IMRT-IGRT
- radiotherapy toxicity
- seminal vesicles
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
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