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

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ClinicalTrials.gov Identifier: NCT02971085
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Wook Jeong, 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.

Condition or disease Intervention/treatment
Prostate Cancer 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 410 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
Actual Study Start Date : December 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.




Primary Outcome Measures :
  1. Pathological reclassification [ Time Frame: 5 year ]
    5-year rate of pathological reclassification during active surveillance


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971085


Contacts
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Contact: Min Ji Seo, Bachelor +82-2-2072-3899 seomj0722@gmail.com
Contact: Chang Wook Jeong, M.D, Ph.D +82-2-2072-3899 drboss@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Chang Wook Jeong, M.D., Ph.D.    +82-2-2072-3899    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.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Chang Wook Jeong, M.D, Ph.D Seoul National University Hospital
Additional Information:

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Responsible Party: Chang Wook Jeong, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02971085    
Other Study ID Numbers: 2016-2957
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Chang Wook Jeong, Seoul National University Hospital:
low-risk prostate cancer
active surveillance
pathologic reclassification
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases