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Clinical Trials in South Korea / NCT02971085
Recruiting Observational

Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance

NCT02971085 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Observational
Started
2016-12
Last updated
2019-02-12

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Active surveillance

Active 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.

Study 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
MALE
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Men \< 80 years 2. Pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores 3. Pre-Bx PSA ≤ 10ng/ml 4. PSA density \< 0.15ng/ml/ml 5. Clinical stage T1-2a 6. Biopsy Gleason score ≤ 6 7. No. of positive cores ≤ 2 8. Maximum cancer involvement in any one core ≤ 20%. 9. No PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T) 10. Participants must be willing to attend the follow-up visits - T1a-b disease should be confirmed by systematic TRUS-Bx ≥ 10 cores Exclusion Criteria: 1\. A former therapy for prostate cancer.

Primary outcome measure(s)

  • Pathological reclassification — 5 year
    5-year rate of pathological reclassification during active surveillance

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02971085 on ClinicalTrials.gov ↗ ← All trials in South Korea