Randomized Phase II selection trial of Stereotactic Prostate Irradiation with Dose Escalated Regio
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000049304
- Lead Sponsor
- Kitasato univeristy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 60
Not provided
(1) Patients with active multiple cancers (excluding metachronous multiple cancers with an expected prognosis of 5 years or longer and synchronous multiple cancers with an expected prognosis of 5 years or longer with treatment) (2) Patients with uncontrolled diabetes (HbAlc 8.0% or more as a guideline) (3) Patients judged by the attending physician to have serious complications such as connective tissue disease, heart disease, respiratory disease, liver disease, etc. (4) Patients who are complicated by psychosis or psychiatric symptoms and are judged to be difficult to participate in the study (5) Patients who have previously received radiotherapy to the pelvis (6) Patients who have undergone surgical therapy for the prostate (transurethral prostatectomy, subcapsular prostatectomy, orchiectomy, etc.) or HIFU (high-intensity focused ultrasound) (7) Patients who received chemotherapy other than androgen deprivation therapy for prostate cancer (8) Patients with inflammatory bowel disease such as Crohn's disease or ulcerative colitis (9) Patients who are judged to be unable to comply with dose restrictions due to the proximity of risk organs such as the urethra and large intestine to the PTV estimated by diagnostic imaging. (10) Patients who are judged inappropriate for clinical trial participation by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method >=Grade 2 toxicity rates at 1 year after treatment
- Secondary Outcome Measures
Name Time Method