Conditions: Prostate Cancer
Keywords: metastatic prostate cancer castration resistant prostate cancer rising PSA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief summary:
This research is being done to test an investigational drug, called itraconazole, in the treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of various fungal infections such as fingernail/toenail infections and other more serious fungal infections. The word "investigational" means that itraconazole is not approved for use in people with cancer. However, the FDA is allowing the use of itraconazole in this research study. Itraconazole has been shown to have activity against cancer (including prostate cancer) in the laboratory, but has not been tested against cancer in humans.

The purpose of this study is to find out:

* If itraconazole is safe when given at two different doses
* How itraconazole affects prostate specific antigen (PSA): a blood test that measures substances released by prostate cancer
* Whether itraconazole can delay further prostate cancer growth and spread
* How itraconazole affects other markers of prostate cancer

Detailed description:
Itraconazole is an oral, generic, and commercially available antifungal drug with a long safety record when used at doses ranging from 200 to 600 mg daily.

Itraconazole has been shown in cellular and animal models to be a potent angiogenesis inhibitor as well as a Hedgehog pathway antagonist; both pathways are considered important in prostate cancer. Itraconazole has not previously been tested as an antineoplastic agent, but given its well-established safety profile, the gap between further preclinical studies and human clinical trials can be narrowed to accelerate development of this agent as a putative anticancer drug. The investigators hypothesize that itraconazole will prevent PSA progression in a significant proportion of men with metastatic CRPC and that it will have an acceptable safety profile at both doses. Itraconazole may ultimately delay the need for chemotherapy in these men.

Arms:
arm 1: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) arm 2: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Interventions: intervention 1: Itraconazole 200 mg intervention 2: Itraconazole 300mg
Intervention descriptions: intervention 1: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) intervention 2: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Protocol document: