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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological reclassification | 5-year rate of pathological reclassification during active surveillance | 5 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. A former therapy for prostate cancer.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Ji Seo, Bachelor | Contact | +82-2-2072-3899 | seomj0722@gmail.com | |
| Chang Wook Jeong, M.D, Ph.D | Contact | +82-2-2072-3899 | drboss@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang Wook Jeong, M.D, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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|
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |