NCT02971085

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Dec 2016Jan 2027

First Submitted

Initial submission to the registry

November 13, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

5.1 years

First QC Date

November 13, 2016

Last Update Submit

February 10, 2019

Conditions

Prostate Cancer

Keywords

low-risk prostate canceractive surveillancepathologic reclassification

Outcome Measures

Primary Outcomes (1)

  • Pathological reclassification

    5-year rate of pathological reclassification during active surveillance

    5 year

Secondary Outcomes (6)

  • active treatment-free survival

    1, 3, 5, 7, 10 years

  • metastasis-free survival

    3, 5, 10 years

  • overall survival

    3, 5, 10 years

  • rates of active surveillance maintenance

    1, 3, 5, 7, 10 years

  • HRQoL scores (measured by EPIC-CP)

    1, 3, 5, 7, 10 years

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Active surveillancePROCEDURE

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.

Active surveillance

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • \. A former therapy for prostate cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Chang Wook Jeong, M.D, Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Ji Seo, Bachelor

CONTACT

+82-2-2072-3899seomj0722@gmail.com

Chang Wook Jeong, M.D, Ph.D

CONTACT

+82-2-2072-3899drboss@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2016

First Posted

November 22, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2022

Study Completion (Estimated)

January 1, 2027

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

KR(1)