Registry for Prostate Cancer with Active Surveillance at Seoul National University
Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
This study is trying to see how many men with low-risk prostate cancer in Korea experience changes in their condition while being monitored closely instead of getting immediate treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 410 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Male |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT02971085 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men under 80 years old with pathologically confirmed low-risk prostate cancer.
Not a fit: Patients who have previously undergone therapy for prostate cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the effectiveness of active surveillance for low-risk prostate cancer, potentially reducing unnecessary treatments.
How similar studies have performed: While active surveillance has been studied in Western populations, this study aims to provide novel data specific to Korean patients, making it a unique contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.