Feasibility of MRI guided focal high-dose-rate brachytherapy for localized prostate cancer (Plaatselijke inwendige bestraling voor patiënten met prostaatkanker).
- Conditions
- High-dose-rate brachytherapyMRI-guidedLocalized prostate cancer
- Registration Number
- NL-OMON21756
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Age =65 years;
2. Patients with prostate cancer, T stage =T2c, Gleason =7, Prostate Specific Antigen (PSA) <10 ng/ml;
3. Tumour location technically feasible for brachytherapy;
4. Karnofski score =70;
5. Written informed consent;
6. Fit for spinal anaesthesia.
1. Previous pelvic radiotherapy for another malignancy;
2. Previous surgery or transurethral resection of the prostate;
3. Prostate cancer recurrence;
4. Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht;
5. International Prostate Symptom Score (IPSS) >15;
6. Anticoagulant administration continuously required;
7. Discongruence between prostate biopsies and MR imaging.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of gastro-intestinal and/or urogenital toxicity, aiming for less than 5% grade =3 toxicity.
- Secondary Outcome Measures
Name Time Method 1. To determine the technical feasibility of MRI guided focal high-dose rate brachytherapy for localized prostate cancer;<br>2. Quality of life;<br>3. Biochemical disease-free survival.
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