RecruitingNCT02971085
Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
Sponsor
Seoul National University Hospital
Enrollment
410 participants
Start Date
Dec 1, 2016
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Sex: MALEMin Age: 40 YearsMax Age: 80 Years
Inclusion Criteria10
- 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 Criteria1
- \. A former therapy for prostate cancer.
Interventions
PROCEDUREActive surveillance
Active surveillance cohorts are routinely performed the systematic biopsy ≥ 12 cores by TRUS-guided or MR-TRUS fusion according to the protocol based by time path as 1, 2, 4, 7, 10 years and subsequently every 5 years following initial TRUS biopsy.
Locations(1)
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NCT02971085
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