Registry for Prostate Cancer with Active Surveillance at Seoul National University

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to establish a prospective cohort registry for men with low-risk prostate cancer undergoing active surveillance at Seoul National University Hospital. The primary goal is to investigate the five-year rates of pathologic reclassification during active surveillance, addressing the need for well-controlled data specific to Korean patients. The study will collect and analyze clinical outcomes to provide evidence supporting active surveillance as a primary treatment strategy for low-risk prostate cancer in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Seoul National University Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Chang Wook Jeong, M.D, Ph.D — Seoul National University Hospital
• Study coordinator: Min Ji Seo, Bachelor
• Email: seomj0722@gmail.com
• Phone: +82-2-2072-3899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.