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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Active surveillance

• Registration Number: NCT02971085
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2016-11-13
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-22
• Study Start: 2016-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12
• Primary Completion: 2022-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 410

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active surveillance	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).

Primary Outcome Measures

Name	Time	Method
Pathological reclassification	5 year	5-year rate of pathological reclassification during active surveillance

Secondary Outcome Measures

Name	Time	Method
HRQoL scores (measured by EPIC-CP)	1, 3, 5, 7, 10 years	HRQoL scores (measured by EPIC-CP)
Utility value (measured by EQ-5D-5L)	1, 3, 5, 7, 10 years	Utility value (measured by EQ-5D-5L)
rates of active surveillance maintenance	1, 3, 5, 7, 10 years	rates of active surveillance maintenance
metastasis-free survival	3, 5, 10 years	metastasis-free survival rate
overall survival	3, 5, 10 years	overall survival rate
active treatment-free survival	1, 3, 5, 7, 10 years	active treatment-free survival rate

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of