A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy of high dose ketoconazole and hydrocortisone in combination with dutasteride (KHAD) in the treatment of hormone refractory prostate cancer.
Steven Balk, MD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Oregon Health and Science University||Portland, Oregon 97201|
|Sidney Kimmel Comprehensive Cancer Center at John Hopkins University||Baltimore, Maryland|