Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
Recruiting · NCT02971085 · Observational (researchers observe without assigning treatment) · Lead sponsor: Seoul National University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Active surveillance
What this trial is about
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.
Who can take part
Age range
40 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
- 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
Exclusion criteria
- \. A former therapy for prostate cancer.
Where it is running
1 location listed.
- Seoul National University Hospital - Seoul, South Korea