Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Seoul National University Hospital
- Enrollment
- 410
- Locations
- 1
- Primary Endpoint
- Pathological reclassification
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
In this study, the investigators aim to establish the prostate cancer active surveillance prospective cohort in our institution, and finally investigate the 5 year rates of reclassification during active surveillance as the primary endpoint of the current study.
Detailed Description
Prostate cancer (PCa) remains one of the most commonly diagnosed malignancies in men worldwide. Early diagnosis and definitive therapy seem to improve oncological outcomes in men with high-risk disease, but significant concerns exist in terms of the overdiagnosis and overtreatment of patients with lower-risk tumors. In this context, active surveillance (AS) has recently emerged as a alternative treatment strategy in PCa patients with low risk cancers. However, published data are based on Western population with different protocol, and therefore; well-controlled data with well-organized and prospective cohort are urgently needed in Korean patients with low-risk PCa because Korean patients have significantly different tumor characteristics compared to Western patients. Here, the investigators have a plan to establish the Seoul National University Enrolled Registry for Prostate Cancer with Active Surveillance, and finally provide the concrete evidence for the clinical outcomes of active surveillance program as the primary therapeutic strategy for low-risk PCa in Korean men.
Investigators
Chang Wook Jeong
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Men \< 80 years
- •Pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores
- •Pre-Bx PSA ≤ 10ng/ml
- •PSA density \< 0.15ng/ml/ml
- •Clinical stage T1-2a
- •Biopsy Gleason score ≤ 6
- •No. of positive cores ≤ 2
- •Maximum cancer involvement in any one core ≤ 20%.
- •No PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T)
- •Participants must be willing to attend the follow-up visits - T1a-b disease should be confirmed by systematic TRUS-Bx ≥ 10 cores
Exclusion Criteria
- •A former therapy for prostate cancer.
Outcomes
Primary Outcomes
Pathological reclassification
Time Frame: 5 year
5-year rate of pathological reclassification during active surveillance
Secondary Outcomes
- rates of active surveillance maintenance(1, 3, 5, 7, 10 years)
- Utility value (measured by EQ-5D-5L)(1, 3, 5, 7, 10 years)
- metastasis-free survival(3, 5, 10 years)
- overall survival(3, 5, 10 years)
- active treatment-free survival(1, 3, 5, 7, 10 years)
- HRQoL scores (measured by EPIC-CP)(1, 3, 5, 7, 10 years)