Medical and Economic Evaluation for Intermediate-risk Prostate Cancer (GETUGP05)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, external beam radiotherapy, brachytherapy boost, economical evaluation
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 80 years;
- life expectancy of greater than 10 years;
- prostate adenocarcinoma histologically proven;
- prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-2.
- the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006);
- the signed consent form.
Exclusion Criteria:
- PSA level > 20;
- Gleason > 7;
- clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion);
- prostate volume > 60 cc;
- pelvic lymph nodes involvement at dissection or imaging (ADP > 1.5 cm);
- concurrent hormone therapy;
- the presence of distant metastasis (M1);
- history of abdominal or pelvic irradiation;
- history of prostate resection in the previous 6 months and/or not allowing the implantation of markers;
- history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma);
- urinary discomfort with an IPSS (International Prostate Symptom Score) > 15 (without alpha-blocking);
- inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
- other undergoing study that may interfere with the present study;
- patient under legal protection measure.
Sites / Locations
- Clinique Claude BernardRecruiting
- CHU Jean MINJOZ
- Clinique TivoliRecruiting
- Institut BergonieRecruiting
- CHRU MorvanRecruiting
- Centre Francois Baclesse
- Centre Georges François LeclercRecruiting
- Hopital de la TroncheRecruiting
- Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon BerardRecruiting
- Centre d'oncologie et de radiothérapie Mâcon
- Institut Paoli CalmetteRecruiting
- Centre Val D'AurelleRecruiting
- Institut de Cancerologie de Lorraine Alexis VautrinRecruiting
- Clinique Hartmann
- Centre Antoine Lacassagne
- Institut CurieRecruiting
- Hopital Saint-LouisRecruiting
- Hopital George Pompidou
- Hospices Civils de LyonRecruiting
- CHU PoitiersRecruiting
- Institut Jean Godinot,
- Polyclinique CourlancyRecruiting
- Centre Eugène MarquisRecruiting
- Centre Henry Becquerel
- Institut Cancérologique de la LoireRecruiting
- Centre Paul StraussRecruiting
- Institut Claudius RegaudRecruiting
- Institut Gustave RoussyRecruiting
- Clinique du TONKIN
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Brachytherapy boost
Exclusive external beam irradiation
Brachytherapy boost with external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds (110Gy) or high dose rate (14Gy) with iridium-192) only to the prostate. Each center will choose the appropriate brachytherapy technique
Exclusive external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.