Phase 2
Completed N=32
Ketoconazole and Dexamethasone in Prostate Cancer
Source: ClinicalTrials.gov NCT01036594 ↗Enrolled (actual)
32
Serious AEs
9.8%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants Who Achieved a Second Decline in Prostate Specific Antigen (PSA) Following Progression on First Regimen — 0 Participants
Summary
This is an open label, phase II, single center trial of ketoconazole/dexamethasone to determine if the administration of ketoconazole/dexamethasone, after disease progression with ketoconazole/hydrocortisone slows or reverses disease progression in men with progressive prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved a Second Decline in Prostate Specific Antigen (PSA) Following Progression on First Regimen |
— | — |
| SECONDARY Median Change Over Time in Adrenocorticotrophic Hormone (ACTH) Levels for Participants Taking Ketoconazole/Hydrocortisone |
— | — |
| SECONDARY Relationship of ACTH to the Duration of Castration Prior to Treatment With Ketoconazole/Hydrocortisone and With Response |
— | — |
| SECONDARY Change in Testosterone Levels Over Time for Participants on Dexamethasone |
— | — |
| SECONDARY Change in Estrodiol Levels Over Time for Participants on Dexamethasone |
— | — |
| SECONDARY Change in Serum Adrenal Androgen (AA) Levels Over Time for Participants on Dexamethasone Over Time |
— | — |
| SECONDARY Change in Cortisol Levels Over Time for Participants on Dexamethasone Over Time |
— | — |
| SECONDARY Change in Dehydroepiandrosterone (DHEA) Levels Over Time for Participants on Dexamethasone Over Time |
— | — |
| SECONDARY Change in Dehydroepiandrosterone Sulfate (DHEA-S) Levels Over Time for Participants on Dexamethasone Over Time |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed adenocarcinoma of the prostate.
- Testosterone 1500/µl, Platelet count > 100,00/µl, Creatinine 8 mg/dl.
Exclusion Criteria
- Prior chemotherapy for prostate cancer is not allowed with the exception of cases in which chemotherapy has been administered in a neoadjuvant or adjuvant fashion AND >1 year has elapsed since the administration of this therapy.
- No prior ketoconazole, abiraterone, aminoglutethimide or corticosteroids for treatment of progressive prostate cancer.
- No supplements or complementary medicines/botanicals are permitted while on protocol therapy, except for any combination of the following: (conventional multivitamin supplements, selenium, lycopene, soy supplements) No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
- No "currently active" second malignancy, other than non-melanoma skin cancer.
- No serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled.
- No psychiatric illnesses/social situations that would limit compliance
- No active or uncontrolled autoimmune disease.
- No adrenal insufficiency as demonstrated by a baseline adrenocorticotropic hormone (ACTH) stimulation test demonstrating a peak cortisol >18 µg/dL.
Data sourced from ClinicalTrials.gov (NCT01036594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.