Conditions: Prostate Cancer
Keywords: Ketoconazole Dexamethasone
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 32
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: po = oral tid = 3 times per day qam = every morning qom = every evening bid = twice daily

1 cycle = 28 days

* Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid
* Hydrocortisone 20mg po qam and 10mg po qpm: If participant has ≥ 30% Prostate-specific antigen (PSA) decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by Prostate Specific Antigen Working Group (PSAWG) criteria) is documented. After that, drug will be discontinued. If participant has \< 30% PSA decline at 12 week evaluation, participant goes off study. arm 2: * Ketoconazole: 400mg po tid
* Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression (by RECIST criteria OR by PSAWG criteria) is documented.

Interventions: intervention 1: Ketoconazole intervention 2: Hydrocortisone intervention 3: Dexamethasone
Intervention descriptions: intervention 1: 200mg during first week of study (run-in phase), then 400mg po tid intervention 2: Hydrocortisone 20mg po qam and 10mg po qpm

If participant has ≥30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If participant has \<30% PSA decline, patient goes off study. intervention 3: Dexamethasone 0.5mg po bid

If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression (by RECIST criteria OR by PSAWG criteria) is documented.

Protocol document: