Seoul National University Hospital
Seoul, 110-744, South Korea
Location status: Recruiting
NCT Number: NCT02971085
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.
Interested in participating?
Request Info40 year–80 year
Male
Observational
Seoul, 110-744, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 5 year
5-year rate of pathological reclassification during active surveillance
Time frame: 1, 3, 5, 7, 10 years
active treatment-free survival rate
Time frame: 3, 5, 10 years
metastasis-free survival rate
Time frame: 3, 5, 10 years
overall survival rate
Time frame: 1, 3, 5, 7, 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)
Interested in participating?
Request InfoSeoul National University Hospital
Other
Acronym: SUPER-PC-AS
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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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