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

NCT ID: NCT02971085

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 410 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2027-01-31

Brief 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.

Detailed Description

Prostate cancer (PCa) remains one of the most commonly diagnosed malignancies in men worldwide. Early diagnosis and definitive therapy seem to improve oncological outcomes in men with high-risk disease, but significant concerns exist in terms of the overdiagnosis and overtreatment of patients with lower-risk tumors. In this context, active surveillance (AS) has recently emerged as a alternative treatment strategy in PCa patients with low risk cancers. However, published data are based on Western population with different protocol, and therefore; well-controlled data with well-organized and prospective cohort are urgently needed in Korean patients with low-risk PCa because Korean patients have significantly different tumor characteristics compared to Western patients. Here, the investigators have a plan to establish the Seoul National University Enrolled Registry for Prostate Cancer with Active Surveillance, and finally provide the concrete evidence for the clinical outcomes of active surveillance program as the primary therapeutic strategy for low-risk PCa in Korean men.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active surveillance

This is the prospective cohort study with single group of active surveillance. We define our cohort group as the patients with following criteria: Men \< 80 years, pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores, pre-biopsy PSA ≤ 10ng/ml, PSA density \< 0.15 ng/ml/ml, clinical stage T1-2a, biopsy Gleason score ≤ 6, number of positive cores ≤ 2, maximum cancer involvement in any one core ≤ 20%, and no PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T).

Active surveillance

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang Wook Jeong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang Wook Jeong, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Min Ji Seo, Bachelor

Role: CONTACT

seomj0722@gmail.com

+82-2-2072-3899

Chang Wook Jeong, M.D, Ph.D

Role: CONTACT

drboss@gmail.com

+82-2-2072-3899

Facility Contacts

Chang Wook Jeong, M.D., Ph.D.

Role: primary

drboss@snuh.org

+82-2-2072-3899

Other Identifiers

2016-2957

Identifier Type: -

Identifier Source: org_study_id