Probach.
- Conditions
- prostate cancerradiotherapieHDR Brachytherapyintermediate risk
- Registration Number
- NL-OMON28094
- Lead Sponsor
- Erasmus MC, Dept. Of RadiationOncologyErasmus MCGroene Hilledijk 3013075 EA Rotterdam+31 10 7041335
- Brief Summary
Publications resulting from this study will be submitted to peer-reviewed journals. Authorship will be: first or second or last, S. Aluwini and/or B. Pieters. The other coauthors will be investigators who have included at least 5% of the evaluable patients by order of inclusion, the statistician and central data manager. Any publication, abstract or preservation based on patients included in this study must be approved by the primary investigators and the study coordinators. This is applicable to any individual patient registered in the trial, or any subgroup of the trial patients. Such a publication cannot include any comparisons between randomized treatment arms or an analysis of any of the study end-points unless the final results of the trial have already been published.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 240
1. Patients ≤ 80 years with histologically proven adenocarcinoma of the
prostate;
1. Other malignancy (except adequately treated basal cell carcinoma of
the skin or other malignancy from which the patient has been cured for
at least 5 years);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of late gastro-intestinal and<br>genito-urinary toxicity (grade ≥ 2 RTOG) during 3 years of<br>follow-up after treatment completion.
- Secondary Outcome Measures
Name Time Method Incidence of acute toxicity, bDFS, RFS,<br>OS, QOL, costs and cost-effectiveness (all costs of treatment<br>and during 5 years of FU after treatment completion).