Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy

NCT ID: NCT00895310

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2015-05-31

Brief 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.

Detailed Description

The aim of the study is to research the response of low dose ketoconazole in hormone refractory prostate cancer (HRPC) patients who have already undergone chemotherapy as part of their prostate cancer treatment. The hypothesis of the study is that HRPC patients who have been previously treated with chemotherapy will demonstrate objective PSA response rates to low dose ketoconazole, comparable to historical response rates reported in chemotherapy-naïve patients. This is a single arm trial, with all participants given ketoconazole 200mg TID, along with hydrocortisone given at 20mg in the morning, 10mg at night daily. Each cycle will consist of 28 days. The subject's study participation will continue until subject experiences disease progression, unacceptable toxicities, withdraws consent from the study or dies.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketoconazole and Hydrocortisone

Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm

Group Type: EXPERIMENTAL

Ketoconazole

Intervention Type: DRUG

Ketoconazole is taken three times a day by mouth.

Hydrocortisone

Intervention Type: DRUG

Hydrocortisone is taken by mouth 20 mg every morning and 10 mg every evening.

Interventions

Ketoconazole

Ketoconazole is taken three times a day by mouth.

Intervention Type: DRUG

Hydrocortisone

Hydrocortisone is taken by mouth 20 mg every morning and 10 mg every evening.

Intervention Type: DRUG

Other Intervention Names

Nizoral; Cortef

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Primo N Lara Jr., MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis Health System

Locations

University of California, Davis Cancer Center

Sacramento, California, United States

Countries

United States

References

Lo EN, Beckett LA, Pan CX, Robles D, Suga JM, Sands JM, Lara PN Jr. Prospective evaluation of low-dose ketoconazole plus hydrocortisone in docetaxel pre-treated castration-resistant prostate cancer patients. Prostate Cancer Prostatic Dis. 2015 Jun;18(2):144-8. doi: 10.1038/pcan.2015.2. Epub 2015 Feb 10.

Reference Type: RESULT

PMID: 25667107 (View on PubMed)

Other Identifiers

UCDCC#218

Identifier Type: OTHER

Identifier Source: secondary_id

200916901

Identifier Type: -

Identifier Source: org_study_id