Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ketoconazole; Hydrocortisone
Intervention description: Ketoconazole is taken three times a day by mouth.; Hydrocortisone is taken by mouth 20 mg every morning and 10 mg every evening.
Intervention MeSH terms: Ketoconazole; Hydrocortisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PSA; Ketoconazole; Prostate Cancer; Hormone Refractory; Chemotherapy Regimen

Summary:

      The purpose of this study is to test the safety of ketoconazole and how well it works after
      chemotherapy has been used. Ketoconazole at lower doses has been used for fungal infections
      however has not yet been approved by the Food and Drug Administration for use in prostate
      cancer. Ketoconazole has been used for many years at high doses for prostate cancer, and this
      study will be to look at use of lower dose ketoconazole after someone has received
      chemotherapy. Ketoconazole works by halting the production of steroids in your body,
      including testosterone, and is thought to work directly on prostate cancer cells in published
      lab studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically proven prostate cancer with a
             Gleason score available or interpretable.

          -  Patients must have prostate cancer deemed to be hormone refractory, by progression of
             measurable or evaluable disease or rising PSA.

          -  Patients must be >18 years old

          -  Patients must have received at least one prior chemotherapy regimen >3 weeks prior to
             initiation of study and patients must have recovered from the side effects of the
             therapy

          -  Patients must have an ECOG status of 0-3

          -  Patients must have normal organ and marrow function, determined within 14 days of
             registration.

          -  Patients must have been surgically or medically castrated. If the method of castration
             was LHRH agonists (leuprolide or goserelin), then the patient must be willing to
             continue the use of LHRH agonists.

          -  Patients must have a serum total testosterone level <50 ng/dl

          -  If the patient has been treated with non-steroidal anti-androgens (flutamide,
             bicalutamide or nilutamide) or other hormonal treatment (megace or steroids), the
             patient must have stopped these agents at least 28 days prior to enrollment for
             flutamide, megace or steroids and at least 42 days prior to enrollment for
             bicalutamide or nilutamide; and the patients must have demonstrated progression of
             disease since the agents were suspended.

        Exclusion Criteria:

          -  Patients with any condition that impairs the ability to swallow medications orally

          -  Patients who are unable to give informed consent

          -  Patients who have received ketoconazole treatment for prostate cancer in the past

          -  Patients with other active malignancies in the past 3 years except nonmelanoma skin
             cancer

          -  Patients may not be receiving any other investigational agents

          -  Patients with known hypersensitivity to ketoconazole

          -  Patients may not be taking certain medications, including terbinafine, astemizole,
             triazolam, statins (except pravastatin and fluvastatin) and acid suppressive agents
             (antacids, H2 blockers, PPI) while on ketoconazole, and patients on these medications
             must agree to discontinue these medications and consider alternative therapies.