Clinical trial · Interventional
Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer
Effect of Dutasteride on Androgen-Response Gene Expression During the Tumor Regrowth Phase of Intermittent Androgen Ablation Therapy in Patients With Advanced Prostate Cancer
NCT00668642CI-TRIAL-00068964completedPhase 2Results postedClinicalTrials.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)
The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dutasteride | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: Dutasteride During First Off-Cycle
- description
- Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle
- interventionNames
- Drug: Dutasteride
- type
- PLACEBO_COMPARATOR
- label
- B: Placebo During First Off-Cycle
- description
- Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate cancer * Patients are hormone-naive * Patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or already receiving therapy with LHRH agonist * Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis * Must have an intact prostate (no previous surgery or XRT) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Recovery from any major infection or surgical procedure * Signed informed consent Exclusion Criteria: * Known intolerance or allergy to dutasteride * Concomitant chemotherapy, biologic therapy, or XRT to prostate * Bilateral orchiectomy * Prior malignancy within 5 years of registration
References
Publications (0)
Data not yet available
No reference posted for this study.