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NCT Number: NCT02971085

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

+82-2-2072-3899

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

PRINCIPAL_INVESTIGATOR

Cheol Kwak, M.D., Ph.D.

SUB_INVESTIGATOR

Hyeon Hoe Kim, M.D., Ph.D.

SUB_INVESTIGATOR

Ja Hyeon Ku, M.D., Ph.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • A former therapy for prostate cancer.

Treatment and study plan

Active Surveillance

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.

Primary outcomes

  1. Pathological reclassification

    Time frame: 5 year

    5-year rate of pathological reclassification during active surveillance

Secondary outcomes

  1. active treatment-free survival

    Time frame: 1, 3, 5, 7, 10 years

    active treatment-free survival rate

  2. metastasis-free survival

    Time frame: 3, 5, 10 years

    metastasis-free survival rate

  3. overall survival

    Time frame: 3, 5, 10 years

    overall survival rate

  4. rates of active surveillance maintenance

    Time frame: 1, 3, 5, 7, 10 years

    rates of active surveillance maintenance

  5. HRQoL scores (measured by EPIC-CP)

    Time frame: 1, 3, 5, 7, 10 years

    HRQoL scores (measured by EPIC-CP)

  6. Utility value (measured by EQ-5D-5L)

    Time frame: 1, 3, 5, 7, 10 years

    Utility value (measured by EQ-5D-5L)

Study contacts

Contact information is provided by the study sponsor or research team.

Chang Wook Jeong, M.D, Ph.D

CONTACT

[email protected]

+82-2-2072-3899

Min Ji Seo, Bachelor

CONTACT

[email protected]

+82-2-2072-3899

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Acronym: SUPER-PC-AS

Important dates

Study start
2016
Primary completion
2022
Study completion
2027
First posted
Nov 22, 2016
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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