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Search / Trial NCT02971085

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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Nov 18, 2016

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Low Risk Prostate Cancer Active Surveillance Pathologic Reclassification

ClinConnect Summary

This clinical trial, based at Seoul National University, is focused on studying how prostate cancer can be monitored without immediate treatment, a method known as active surveillance. Researchers want to understand how many men experience changes in their cancer status over five years while being closely monitored. This study is currently recruiting male participants who are under 80 years old and have been diagnosed with a specific type of prostate cancer based on a biopsy.

To be eligible for this trial, men must have a certain level of prostate-specific antigen (PSA) and meet other criteria related to their cancer's characteristics. Participants will need to commit to regular follow-up visits to check on their condition over time. This trial is important for improving how we manage prostate cancer in men who may not need immediate treatment, allowing for better, more personalized care.

Gender

MALE

Eligibility 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.

About Seoul National University Hospital

Seoul National University Hospital (SNUH) is a leading medical institution in South Korea, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SNUH integrates cutting-edge scientific inquiry with patient-centered care, facilitating the development of novel therapies and treatment protocols. The hospital boasts a diverse range of specialized departments and a robust infrastructure for conducting clinical studies, ensuring rigorous adherence to ethical standards and regulatory compliance. By fostering collaboration among multidisciplinary teams, SNUH aims to contribute significantly to global medical advancements and improve patient outcomes.

Locations

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Chang Wook Jeong, M.D, Ph.D

Principal Investigator

Seoul National University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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