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Investigator(s):
William L. Dahut, M.D. Principal Investigator Phone: 301-435-8183 dahutw@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov	Melony Beatson, R.N., B.A., B.S.N. Research Nurse Phone: 301-435-5614 Fax: 301-451-5730 beatsonm@mail.nih.gov

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Key Eligibility Criteria:

• Histologically or cytologically proven metastatic, progressive, castrate-resistant prostate cancer (CRPC)
• Radiographic evidence of disease after primary treatment with surgery or radiotherapy that has continued to progress radiographically or biochemically (rising PSA levels on successive measurements) despite adequate androgen-deprivation therapy
• Metastatic disease, defined as at least one lesion on bone scan or at least one lesion that can be accurately measured in at least one dimension
• Progression must be evidenced and documented by any of the following:
• Two consecutively rising PSA values, above the baseline, at a minimum of 1- week intervals
• Appearance of one or more new lesions on bone scan
• Progressive measurable disease
• The use of androgen receptor inhibitors is not required prior to study entry*
• No prior treatment with docetaxel for metastatic disease
• ≥ 18 years of age
• ECOG performance status ≤ 2
• Adequate organ function as defined by liver, kidney, and hematologic laboratory testing
• Able to swallow whole tablets

*For those patients receiving an anti-androgen agent (flutamide, bicalutamide, or nilutamide), for at least six consecutive months immediately prior to study entry, and are entering the trial because of a rise in PSA, they must demonstrate a continued rise in PSA within four weeks after stopping flutamide and within six weeks after stopping bicalutamide or nilutamide. Flutamide, nilutamide, and bicalutamide disease progression requirements only apply to patients who have been on these drugs for at least the prior six months.

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Study Outline:

• Screening physical examination, blood tests, and imaging studies to determine eligibility for the study
• Eligible participants will receive
• Docetaxel through an IV catheter (a plastic tube usually inserted in a vein) on Day 1 of each 21-day cycle
• Cabozantinib and prednisone tablets by mouth every day of each 21-day cycle
• Cycles continue for as long as there is no progressive disease or unacceptable toxicity
• Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 10/22/12