Partial or whole gland brachytherapy to maintain erections
Recruiting
- Conditions
- Erectile dysfunction (erectiele disfunctie), Focal prostate brachytherapy (Focale prostaat brachytherapie), Late radiation effects (Late bestralingseffecten), Quality of life (Kwaliteit van leven). Oncologic efficacy (Oncologische effectiviteit)
- Registration Number
- NL-OMON26328
- Lead Sponsor
- Amsterdam Universitair Medisch Centrum, location Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 254
Inclusion Criteria
1. Histologically adenocarcinoma confirmed on systematic biopsies and targeted biopsies after mpMRI. Optional is to perform template prostate biopsies (18-26 cores) with targeted biopsies after mpMRI
2. Unilateral significant tumor confirmed by histology (see point 4).
Exclusion Criteria
1. Contraindication for mpMRI
2. Bleeding disorder preventing invasive treatment as a prostate implantation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Deterioration of erectile function by assessment of the IIEF-5 score. A drop of at least 5 points compared to baseline value or a need to start with a phosphodiesterase 5 inhibitor (PDE5 inhibitor) (or other medical interventions to improve erections) at last follow- up is considered as an event.
- Secondary Outcome Measures
Name Time Method The incidence of late gastro-intestinal (GI) and genito-urinary (GU) toxicity (CTCAEv4 and IPSS) <br /><br><br /><br>quality of life after treatment completion (EORTC QLQ-C30 and PR25)<br /><br><br /><br>Progression of local disease histologically and radiological.