ocal HDR brachytherapy in case of localized prostate cancer
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00010911
- Lead Sponsor
- niversitätsklinik für Radiologie und Nuklearmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 37
Patients between 18 and 80 years, with a localized tumor of the prostate under low-risk or intermediate risk early to D'Amico, the standard procedures, such as percutaneous radiotherapy, radical prostatectomy or active surveillance refuse.
In preoperatively performed multiparametric MRI (mpMRT) at least one suspicious lesion with a PI-RADS score must be described by 4/5.
• Age 18 aged 80 or a life expectancy of at least 10 years
• MR biopsy or prostate fusionsbioptisch secured
• In accordance distinctly visible index lesions with PI-RADS score 4/5
• consent of focal treatment by using brachytherapy
• refusal of also introduced standard treatments
several suspect lesion in mpMRT with a PI-RADS score of 4/5. Furthermore, symptoms that preoperatively additional treatments of the prostate makes necessary (z. B. TURP) equipment and other obstacles which do not allow to carry out the therapy.
• Missing capacity to consent
• evidence of lymph node or metastasis in the CT or MRI
• no suspect MR lesion (PIRADS 4/5)
• several suspect MR lesions (PIRADS 4/5)
• ongoing antihormonal therapy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective of the study is to establish a new method of treatment for prostate cancer, showing minimal side effects for the patient. <br>Parameters will be analyzed with a Safety (SAE management / side effect and quality of life questionnaires) which will be collected during study.
- Secondary Outcome Measures
Name Time Method Evidence based of improvment in quality of life compared with standard therapy methods by patient satisfaction.