Clinical trial · Interventional
Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Participants are no longer being examined and receiving intervention.
Summary
Brief summary (as posted)
Active Surveillance manages selected men with prostate cancer expectantly with curative intent. This means men are carefully selected and subsequently actively observed in order to have the possibility to offer them curative treatment once the tumor seems to progress. The goal of this study is to validate the treatment option Active Surveillance in men with localized, well differentiated prostate cancer, in order to limit the amount of overtreatment. A number of key points will be studied, such as the pathological findings in radical prostatectomy specimens, and the effect of expectancy on the quality of life.
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 |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Epstein + (group I)
- description
- Epstein + (Group I) PSA \<10 ng/ml; Gleason 3+3=6; Number of positive biopsies ≤3/12; % of tumor biopsy invasion \<50% or ≤3mm; mp MRI negative; c-rTNM T1-T2a N0 M0
- interventionNames
- Other: Active surveillance
- type
- EXPERIMENTAL
- label
- Epstein - (group II)
- description
- Epstein - (Group II) PSA \<15 ng/ml; Gleason score max 3+4; Number of positive biopsies ≤5/12 % of tumor biopsy invasion \<50% and ≤8mm; mp MRI positive; T1-T2c N0 M0
- interventionNames
- Other: Active surveillance
Primary outcomes (1)
- measure
- Proportion of patients on active surveillance in group Epstein + and Epstein -
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Localized adenocarcinoma of the prostate with a Gleason score of 3+3 (group I patients) or 3+4 (group II patients) * Percentage of tumor biopsy invasion \<50% and/or with a size of maximum 8 mm * With a number of positive tumor biopsies ≤3 (group I patients) or ≤ 5 (group II patients) * TNM stage T1-2a N0 M0 (group I patients); TNM stage T1-2c N0 M0 (group II patients) * PSA level at diagnosis \< 10 ng/ml for group I patients; \< 15 ng/ml for group II patients * Tumor volume negative (group I patients); positive (group II patients) * Absence of extra-capsular extension * Life expectancy \> 10 years * Signed informed consent * Patient has elected active surveillance as preferred management plan for the prostate cancer Exclusion Criteria: * Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy) * Patients with hypogonadism
References
Publications (0)
Data not yet available