Clinical trial · Observational
Response of Patients on Surveillance for Prostate Cancer to Dutasteride
Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride
NCT01525914CI-TRIAL-00006194completedClinicalTrials.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)
Hypothesis: That, in men on surveillance for favorable risk prostate cancer treated with dutasteride, prostate specific antigen (PSA) kinetics is of value in identifying those men who harbor occult high grade prostate cancer. The study will determine the prevalence of a secondary rise in PSA \> 0.5 ng/ml and the PSA doubling time in subjects on surveillance being treated with dutasteride.
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 |
|---|---|---|---|
| Dutasteride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- dutasteride, active surveillance
- description
- men with favorable risk prostate cancer on surveillance treated with dutasteride
- interventionNames
- Drug: Dutasteride
Primary outcomes (1)
- measure
- change in serum PSA
- timeFrame
- change from baseline in serum PSA up to secondary rise in serum PSA > 0.5, up to 6 months
- description
- The time that the change in serum PSA from baseline to the secondary rise will be used to determine the PSA 'kinetics' in men on surveillance for prostate cancer.
Secondary outcomes (1)
- measure
- rate of secondary rise in serum PSA
- timeFrame
- at 6 months after starting dutasteride therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients on active surveillance for favorable risk prostate cancer who have been treated with dutasteride following the diagnosis of cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.