Prostate Cancer
Conditions
Keywords
Prostate, external beam radiotherapy, brachytherapy boost, economical evaluation
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.
Interventions
RADIATIONBrachytherapy boost with external beam radiotherapy
Bras A: External beam radiotherapy of 46 Gy delivered with a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds from Bard (110Gy) or high dose rate (14Gy) with a iridium-192 source) only to the prostate. Each center will choose the appropriate brachytherapy technique. The number of seeds or needles will depend on the prostate's volume.
RADIATIONExclusive external beam radiotherapy
Bras B: External beam radiotherapy of 46 Gy delivered with photons and a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactOlivier CHAPET, MD
Backup ContactJulien BERTHILLER
Outcome results
None listed