Prostate Cancer
Conditions
Keywords
low-risk prostate cancer, active surveillance, pathologic reclassification
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.
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.
Interventions
PROCEDUREActive 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.
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological reclassification | 5 year | 5-year rate of pathological reclassification during active surveillance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3, 5, 10 years | overall survival rate |
| rates of active surveillance maintenance | 1, 3, 5, 7, 10 years | rates of active surveillance maintenance |
| metastasis-free survival | 3, 5, 10 years | metastasis-free survival rate |
| Utility value (measured by EQ-5D-5L) | 1, 3, 5, 7, 10 years | Utility value (measured by EQ-5D-5L) |
| active treatment-free survival | 1, 3, 5, 7, 10 years | active treatment-free survival rate |
| HRQoL scores (measured by EPIC-CP) | 1, 3, 5, 7, 10 years | HRQoL scores (measured by EPIC-CP) |
Countries
South Korea
Contacts
Primary ContactMin Ji Seo, Bachelor
Backup ContactChang Wook Jeong, M.D, Ph.D
Outcome results
None listed