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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Active surveillance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men < 80 years Pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores Pre-Bx PSA ≤ 10ng/ml PSA density < 0.15ng/ml/ml Clinical stage T1-2a Biopsy Gleason score ≤ 6 No. of positive cores ≤ 2 Maximum cancer involvement in any one core ≤ 20%. No PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T) 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active surveillance<br>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). | Procedure: Active surveillance<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological reclassification | 5-year rate of pathological reclassification during active surveillance | 5 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-risk prostate cancer, active surveillance, pathologic reclassification