Phase I dose-escalation study of stereotactic body radiation therapy for prostate cancer
Phase 1
Recruiting
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000039444
- Lead Sponsor
- The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 72
Inclusion Criteria
Not provided
Exclusion Criteria
a) Refusal to participate b) Lymph node or distant metastasis c) History of treatment except hormone therapy for prostate cancer d) History of radiotherapy for pelvic region e) Inflammatory bowel disease like ulcerative colitis and Crohn's disease f) History of surgery for rectal disease g) Participants of other clinical trial that may affect the result of this study h) Ineligible patients judged by investigators Following patients were ineligible for injection of hydrogel spacer i) Difficult to insert the ultrasound probe into the rectum j) Allergic to local anesthetic agents k) Rectum invasion or dorsal extracapsular invasion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of CTCAE grade 3-5 toxicity during the initiation of radiotherapy and 180 days from the end of radiotherapy. Toxicities will be graded using CTCAE version 5.0.
- Secondary Outcome Measures
Name Time Method The incidence of toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy The incidence of toxicity during the follow-up period after 91 days from the end of radiotherapy The incidence of toxicity caused by injection of hydrogel spacer The incidence of patient-reported toxicity based on PRO-CTCAE version 1.0 Quality of life using EPIC and FACT-P The International Prostate Symptom Score (IPSS) Overall survival biochemical recurrence-free survival using the Phoenix definition of biochemical failure