Clinical trial · Observational
Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
NCT02971085CI-TRIAL-00037055SUPER-PC-ASrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active surveillance | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Active surveillance
- description
- 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).
- interventionNames
- Procedure: Active surveillance
Primary outcomes (1)
- measure
- Pathological reclassification
- timeFrame
- 5 year
- description
- 5-year rate of pathological reclassification during active surveillance
Secondary outcomes (6)
- measure
- active treatment-free survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.