Real-time tumor-tracking proton beam therapy for prostate cancer
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000016573
- Lead Sponsor
- Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 45
Not provided
1)Pathologically proven non-adenocarcinoma or mixed type adenocarcinoma of the prostate 2)Clinically obvious lymph node or distant metastasis 3)With active other cancers 4)With severe uncontrolled diabetes 5)With severe heart disease, or some serious complications, i.e., SLE, Scleroderma 6)With an inflammatory bowel syndrome, i.e., Crohn's disease, ulcerative colitis 7)Previous surgical treatment or High-intensity focused ultrasound (HIFU) for prostate 8)Previous chemotherapy for prostate cancer before enrollment 9)Previous surgery to pelvis, except for appendectomy 10)Previous radiotherapy to pelvis 11)With implantable cardioverter defibrillator or permanent pacemaker 12)Allergic to radiation 13)Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 14)Cannot be held rest for about 30 minutes 15)Cannot be implanted Au marker in the prostate 16)Weight over 135 kg 17)Unsuitable for enrollment judged by principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of early adverse effects within 90 days after real-time tumor-tracking proton beam therapy
- Secondary Outcome Measures
Name Time Method Relapse free survival, incidence of adverse effect of Grade 3 or higher and cost-effectiveness at 18 months, incidence of dropout and migration of Au markers during treatment period