HYpofractionated irradiation for PROstate cancerA randomized multicenter phase III study.
- Conditions
- Prostate cancer has become the most common non-skin malignancy in men in Western countries. Over recent years the number of diagnosed patients has increased dramatically because of routine prostate-specific antigen (PSA) testing. For a large proportion of prostate cancer patients, external-beam radiotherapy (EBRT) will be the treatment of choice.
- Registration Number
- NL-OMON22744
- Lead Sponsor
- Erasmus MC-Daniel den Hoed Cancer Center, Rotterdam, Netherlands Cancer Institute, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
1. Histologically proven adenocarcinoma of
the prostate
Exclusion Criteria
1. Pretreatment PSA >/= 60 µg/l
2. Previous irradiation in the pelvic region or radical prostatectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-year relapse free survival after treatment. Relapse is defined as biochemical relapse, clinical relapse, loco-regional or distant relapse or start with hormonal therapy, whichever occurs first. Biochemical relapse will be defined in this study as PSA greater than the current nadir plus 2 mg/l, without backdating. <br /><br>Other endpoints of this study will be:<br /><br>The acute gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system. <br /><br>The late gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system. <br>
- Secondary Outcome Measures
Name Time Method Quality of life by using the EORTC-PR25 prostate module, and erectile functioning by using the International Index of Erectile Function (IIEF).