Medical and Economic Evaluation for Intermediate-risk Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Brachytherapy boost with external beam radiotherapyRadiation: Exclusive external beam radiotherapy
- Registration Number
- NCT02271659
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.
The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 298
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brachytherapy boost Brachytherapy boost with external beam radiotherapy 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 irradiation Exclusive external beam radiotherapy 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.
- Primary Outcome Measures
Name Time Method Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy 5 years Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms
- Secondary Outcome Measures
Name Time Method The evaluation of the overall survival at 5 years. 5 years All cause mortality
The evaluation of the specific survival at 5 years 5 years Mortality due to prostate cancer
The evaluation of the survival without any metastatic evolution at 5 years 5 years The study of all toxicities 5 years The toxicities include: acute and late toxicities, sexual toxicities, the quality of life of the patients (CTCAE version 4.0)
Medical and economical evaluation. 5 years The complete medical and economical evaluation of the strategies
Trial Locations
- Locations (29)
CHU Jean MINJOZ
🇫🇷Besançon, France
Clinique Tivoli
🇫🇷Bordeaux, France
Institut Bergonie
🇫🇷Bordeaux, France
CHRU Morvan
🇫🇷Brest, France
Centre Francois Baclesse
🇫🇷Caen, France
Institut de Cancerologie de Lorraine Alexis Vautrin
🇫🇷Nancy, France
Centre d'oncologie et de radiothérapie Mâcon
🇫🇷Macon, France
Clinique Claude Bernard
🇫🇷Albi, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Institut Curie
🇫🇷Paris, France
Hopital de la Tronche
🇫🇷Grenoble, France
Institut Paoli Calmette
🇫🇷Marseille, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Val D'Aurelle
🇫🇷Montpellier, France
Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard
🇫🇷Lyon, France
Clinique Hartmann
🇫🇷Neuilly Sur Seine, France
Hopital Saint-Louis
🇫🇷Paris, France
Hospices Civils de Lyon
🇫🇷Pierre-Bénite, France
CHU Poitiers
🇫🇷Poitiers, France
Centre Eugène Marquis
🇫🇷Rennes, France
Hopital George Pompidou
🇫🇷Paris, France
Centre Henry Becquerel
🇫🇷Rouen, France
Polyclinique Courlancy
🇫🇷Reims, France
Institut Jean Godinot,
🇫🇷Reims, France
Institut Cancérologique de la Loire
🇫🇷Saint-priest En Jarez, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Clinique du TONKIN
🇫🇷Villeurbanne, France