Proton therapy of prostate cancer: Prospective evaluation of effectiveness and side effects with standard clinical doses
Not Applicable
Recruiting
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00008754
- Lead Sponsor
- niversitätsklinikum DresdenKlinik und Poliklinik für Strahlentherapie und Radioonkologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 255
Inclusion Criteria
Histologically confirmed, localized, locally advanced or loko-regional advanced prostate cancer
- ECOG <= 2
- Indication for curative radiotherapy
- Capacity to consent and written consent of the patient
Exclusion Criteria
- No known distant metastases (e.g. lung/bones/lymph nodes, etc.)
- Missing capacity to consent or lack of written consent
- Missing or limited possibility of reproducible positioning (e.g. by severe restriction of mobility of the patient)
- Contraindications to rectum balloon
- Previous radiation therapy to the pelvis
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method >= Grade II toxicity (CTCAE 4.0) after 2 years; evaluation by one-sided one-sample binomial test with normal approximation
- Secondary Outcome Measures
Name Time Method PSA relapse-free survival , local tumor control, overall survival, prostate cancer specific survival, clinical progression-free survival, acute toxicity >= grade II after 2 years in each case; evaluation by single-sided one-sample binomial test with normal approximation