Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance (SUPER-PC-AS)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Active surveillance

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 Type: Observational
• Enrollment (Anticipated): 410

Contacts and Locations

• Study Contact: Name: Min Ji Seo, Bachelor; Phone Number: +82-2-2072-3899; Email: seomj0722@gmail.com
• Study Contact Backup: Name: Chang Wook Jeong, M.D, Ph.D; Phone Number: +82-2-2072-3899; Email: drboss@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Chang Wook Jeong, M.D., Ph.D.; Phone Number: +82-2-2072-3899; Email: drboss@snuh.org
    • Principal Investigator: Chang Wook Jeong, M.D., Ph.D.
    • Sub-Investigator: Hyeon Hoe Kim, M.D., Ph.D.
    • Sub-Investigator: Cheol Kwak, M.D., Ph.D.
    • Sub-Investigator: Ja Hyeon Ku, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Korean men with pathologically proven adenocarcinoma of prostate cancer with low-risk who will be treated by active surveillance protocol in Seoul National University Hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chang Wook Jeong, M.D, Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: November 13, 2016
• First Submitted That Met QC Criteria: November 18, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: active surveillance; low-risk prostate cancer; pathologic reclassification
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2016-2957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided