Hypofractionated Proton Beam Therapy of 51.6Gy(RBE) in 12 fractions (3 weeks) with real-time-image gated spot-scanning system for non-metastatic prostate cancer (T1c-T4N0M0)
Phase 2
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000046163
- Lead Sponsor
- Kyoto Prefectural University of Medicine Department of Radiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 180
Inclusion Criteria
Not provided
Exclusion Criteria
Prior radiotherapy to the pelvic area Prior prostate cancer therapy such as: prostatectomy, radiation therapy, chemotherapy or high intensity focused ultrasound (HIFU) . Patients with previous Transurethral Resection of the Prostate (TURP) performed for urinary retention may be included. Second invasive malignancy (except of carcinoma in situ, treated by optimal therapy) if not controlled within last 5 years. It is clinically difficult to place fiducial markers into prostate. There is uncontrollable inflammation in pelvic lesion or inflammatory systemic disease. It is difficult to provide study-specific informed consent prior to study entry.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Genitourinary early adverse effects (at and up to 13 weeks: from the start of treatment) Genitourinary late adverse effects (at and up to 5 years: from 13 weeks after the start of treatment)
- Secondary Outcome Measures
Name Time Method