Prostate CancerSUPER-PC-ASNCT02971085
Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
An observational study of Prostate Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Active surveillance
- Type of treatment
- Surgery or procedure
- How many people
- 410 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Jan 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 1. A former therapy for prostate cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Chang Wook Jeong, M.D., Ph.D., +82-2-2072-3899, drboss@snuh.org
Chang Wook Jeong, M.D., Ph.D.
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Active surveillance
- Keywords
- low-risk prostate cancer, active surveillance, pathologic reclassification
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological reclassification
5-year rate of pathological reclassification during active surveillance
Measured: 5 year
Secondary outcomes (6)
active treatment-free survival
active treatment-free survival rate
Measured: 1, 3, 5, 7, 10 years
metastasis-free survival
metastasis-free survival rate
Measured: 3, 5, 10 years
overall survival
overall survival rate
Measured: 3, 5, 10 years
rates of active surveillance maintenance
rates of active surveillance maintenance
Measured: 1, 3, 5, 7, 10 years
HRQoL scores (measured by EPIC-CP)
HRQoL scores (measured by EPIC-CP)
Measured: 1, 3, 5, 7, 10 years
Utility value (measured by EQ-5D-5L)
Utility value (measured by EQ-5D-5L)
Measured: 1, 3, 5, 7, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2022 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 410 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Wook Jeong, Seoul National University Hospital
- Investigators
- Chang Wook Jeong, M.D, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971085
- Sponsor's protocol ID
- 2016-2957
- Acronym
- SUPER-PC-AS
- Status last verified
- Feb 2019
- First submitted
- 13 Nov 2016
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
- ClinicalTrials.gov ID
- NCT02971085
- Acronym / sponsor ID
- SUPER-PC-AS / 2016-2957
- Conditions
- Prostate Cancer
- Keywords
- low-risk prostate cancer, active surveillance, pathologic reclassification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active surveillance | – | Procedure: Active surveillanceThis 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). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- 1. A former therapy for prostate cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active surveillanceActive 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. | Procedure or surgery | Active surveillance |
Primary outcome
Pathological reclassification
Time frame: 5 year
5-year rate of pathological reclassification during active surveillance
6 secondary outcomes
active treatment-free survival
Time frame: 1, 3, 5, 7, 10 years
metastasis-free survival
Time frame: 3, 5, 10 years
overall survival
Time frame: 3, 5, 10 years
rates of active surveillance maintenance
Time frame: 1, 3, 5, 7, 10 years
HRQoL scores (measured by EPIC-CP)
Time frame: 1, 3, 5, 7, 10 years
Utility value (measured by EQ-5D-5L)
Time frame: 1, 3, 5, 7, 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chang Wook Jeong, M.D, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Ji Seo, Bachelor (+82-2-2072-3899, seomj0722@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological reclassification (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.