Clinical trial · Observational
Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
NCT01376661CI-TRIAL-00051037terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early termination due to PI's decision to discontinue research activities.
Summary
Brief summary (as posted)
The purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Active Surveillance/ Prostate Cancer
Primary outcomes (1)
- measure
- Percentage of enrolled subjects who remain compliant free until disease progression.
- timeFrame
- 10 years
- description
- This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer
Secondary outcomes (4)
- measure
- Percentage of enrolled subjects who require definitive therapy
- timeFrame
- 10 years
- measure
- Quality of Life as measured by patient survey.
- timeFrame
- 10 Years
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age * Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated. * PSA \< 10 ng/ml within 1 month of program enrollment * Clinical stage less than or equal to T2a * Biopsy sampling with at least 10-12 cores * Gleason score less than or equal to 3 + 3 * No more than 2 cores involved * No core more than 50% involved * Eligible for definitive therapy * Able to provide informed consent * Able to complete a QOL questionnaire * Able to comply with the scheduled follow-up appointments Exclusion Criteria: * See inclusion criteria for eligibility
References
Publications (0)
Data not yet available
No reference posted for this study.