localized prostate carcinoma prostate cancer
Conditions
Interventions
High-dose-rate brachytherapy will be performed for patients with low to
intermediate risk prostate carcinoma. The treatment will include a single
fraction of 19 Gy. High-dose-rate brachytherapy will
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 65 years - Patients with prostate cancer, T stage =70 - Written informed consent - Fit for spinal anaesthesia
Exclusion criteria
Exclusion criteria: - Previous pelvic radiotherapy for another malignancy - Previous surgery or transurethral resection of the prostate - Prostate cancer recurrence - Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht - International Prostate Symptom Score (IPSS) >15 - Anticoagulant administration continuously required, except for platelet aggregation inhibitors (for example Ascal/Persantin) - Discongruence between prostate biopsies and MR imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of gastro-intestinal and/or urogenital toxicity, aiming for less than 5% grade >=3 toxicity will be determined by the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 (National Cancer Institute). | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine the technical feasibility of MRI guided focal high-dose rate brachytherapy for localized prostate cancer - Quality of life - Biochemical disease free survival | — |
Countries
Netherlands
Outcome results
None listed