Randomized Phase 3 Study On The Assessment Of Late ToxicityBy Comparing IMRT High Dose External Beam Radiotherapy OnlyWith External Beam Radiotherapy Combined With HDR Or PDRBrachytherapy In Patients With Intermediate/high Risk ProstateCancer.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 240
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Patients ≤ 80 years with histologically proven adenocarcinoma of the
Exclusion Criteria
- •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);