Status:
UNKNOWN
Medical and Economic Evaluation for Intermediate-risk Prostate Cancer
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT02271659
Start Date
June 1 2013
End Date
June 1 2021
Last Update
September 13 2016
Active Locations (29)
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1
Clinique Claude Bernard
Albi, France, 81000
2
CHU Jean MINJOZ
Besançon, France, 25030
3
Clinique Tivoli
Bordeaux, France, 33000
4
Institut Bergonie
Bordeaux, France, 33076