Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000026213
- Lead Sponsor
- The University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 42
Not provided
Patients with lymph node metastasis and or distant metastasis History of prostate cancer treatment (surgery, high intensity focused ultrasound, chemotherapy) Hormone therapy >= 12 months before radiotherapy History of pelvic radiotherapy History of any other malignancy within 2 years (except carcinoma in situ) Severe cardiovascular disease Severe respiratory disease Liver disease (AST, ALT >20 x ULN) Severe kidney disease requiring hemodialysis Unable to provide written informed consent Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) History of lowerpelvic surgery Metal in pelvic or near pelvic area (e.g. total hip replacement) affecting pelvic CT scan Bleeding tendency that may disrupt hydrogel spacer insertion (Plt <= 100000, PT INR > 1.5 ULN (with anticoagulant, PT INR > 2.5 ULN), APTT >= 2 x ULN) Unable to insert ultrasound probe (e.g. anal stenosis) Allergic to local anesthetics Considered not appropriate for the study by investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All acute gastrointestinal toxicity
- Secondary Outcome Measures
Name Time Method Dose Volume Histogram Adverse events related to spacer insertion Success rate of spacer insertion Position of the spacer at the last day of radiotherapy Acute genitourinary toxicity Late gastrointestinal and genitourinary toxicity Other toxicities related to radiotherapy QOL:Expanded Prostate Cancer Index Composite (EPIC) and Functional Assessment of Cancer Therapy Prostate (FACT P) The International Prostate Symptom Score (IPSS) Biochemical failure free survival