Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Anti-Infective Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Hormones

Ketoconazole

Dutasteride

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

5-alpha Reductase Inhibitors

Ketoconazole, Hydrocortisone and Dutasteride Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Dutasteride: 0.5 mg once a day

Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Pills should be taken with food or milk.

Dutasteride: 0.5mg orally once a day on an empty stomach or after eating a meal

Ketoconazole, Hydrocortisone and Dutasteride

Steven Balk, MD

The combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating prostate cancer.

* Participants will be seen by the study physician every four weeks and have a short physical examination, blood tests and be asked to provide information about their condition. Every three months they will undergo a bone scan. If the CT scan that was obtained before the participant started the study shows evidence of cancer, they will be asked to repeat this test every three months.
* Ketaconazole will be taken orally three times a day on an empty stomach. Hydrocortisone will be taken orally in the morning and at night. Dutasteride will be taken orally once a day.
* Participants may remain on study drug until there is evidence of disease progression.

Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.

Duration of time from treatment initiation until documented progression (PSA or Disease progression)

Massachusetts General Hospital

Dana-Farber Cancer Institute

Sunnybrook Health Sciences Centre

Oregon Health and Science University

M.D. Anderson Cancer Center

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Beth Israel Deaconess Medical Center

Principle Investigator

KHAD

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Canada

Region of Enrollment

Steven Balk

PSA Response

KHAD: ketoconazole, hydrocortisone and dutasteride for CRPC

Time to Progression

KHAD; ketoconazole, hydrocortisone and dutasteride for CRPC

Overall Study

Spots Global Cancer Trial Database for ketoconazole, hydrocortisone and dutasteride