Clinical trial · Interventional
Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
NCT00673127CI-TRIAL-00017614KHADcompletedPhase 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 combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketoconazole, Hydrocortisone and Dutasteride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KHAD
- description
- Ketoconazole, Hydrocortisone and Dutasteride Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Dutasteride: 0.5 mg once a day
- interventionNames
- Drug: Ketoconazole, Hydrocortisone and Dutasteride
Primary outcomes (1)
- measure
- PSA Response
- timeFrame
- From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.
- description
- PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
Secondary outcomes (1)
- measure
- Time to Progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). In the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum PSA and metastatic lesions on bone scan. * Progressive HRPC defined as a PSA increase over baseline of \>25% or 5ng/ml or new lesions on bone/CT scan after conventional androgen deprivation and antiandrogen withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not required. * PSA of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml * Prior chemotherapy is permitted if discontinued \> 4 weeks prior to starting therapy * Prior therapy with estrogens is permitted but must have been discontinued \> 4 weeks prior to registration * ECOG Performance Status 0-2 * Adequate renal function, hepatic function, and bone marrow function as outlined in protocol * ECG showing a normal QT interval Exclusion Criteria: * Prior therapy with ketoconazole or corticosteroids for HRPC * Major surgery or radiation therapy within 4 weeks * Strontium-89 or samarium-153 therapy within 4 weeks * Thromboembolism in past 6 months * Patients who are taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes. * Concomitant use of drugs known to be narrow therapeutic index CTP3A4 * Drugs that are sensitive CYP3A4 substrates * Alcohol or drug dependence currently or in the last 6 months
References
Publications (0)
Data not yet available
No reference posted for this study.