ongitudinal intervention study using interim treatment-free observation as the initial treatment strategy for stage T1c prostate cancer
Phase 2
- Conditions
- prostate cancer
- Registration Number
- JPRN-UMIN000052842
- Lead Sponsor
- Kagawa University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 134
Inclusion Criteria
Not provided
Exclusion Criteria
Patients with a history of cerebral infarction, unstable angina, diabetes uncontrolled by insulin, severe hypertension, or myocardial infarction within 6 months
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with a PSA doubling time of more than 2 years at 6 months after enrollment among patients selected for active surveillance
- Secondary Outcome Measures
Name Time Method 1) Percentage of patients who met the pathological eligibility criteria at the time of enrollment as a result of re-biopsy among patients selected for active surveillance who underwent re-biopsy performed 13 months after enrollment 2) Percentage of patients who underwent total prostatectomy as the first treatment for prostate cancer within 6 months of enrollment who had a pathology diagnosis of Non Organ Confined Disease in the resected specimen. 3) Adverse events in patients receiving active treatment 4) Degree of decline in her QOL in patients choosing active surveillance and patients choosing active treatment 5) Overall survival time in patients who selected active surveillance and patients who selected active therapy 6) Metastasis-free survival time in patients who selected active surveillance and patients who selected active therapy