The primary objective of the study is to evaluate change in circulating tumor cell (CTC) counts over time in men with metastatic treatment-refractory CRPC in response to temsirolimus therapy.

This is a single arm study of 20 men with treatment refractory metastatic CRPC who will receive temsirolimus IV at a dose of 25 mg weekly until progression.

Progression will not include PSA progression; however, upon PSA progression, the addition of an anti-androgen will be permitted.

Eligibility Criteria

You may be eligible to participate in this trial if you meet the following criteria:

• Histologically confirmed carcinoma of the prostate (through local or metastatic biopsy review)
• Radiographic evidence of metastatic disease
• Evidence of disease progression despite castrate levels of testosterone
• A circulating tumor cell count using FDA approved CellSearch methodology of ≥ 10 per 7.5 cc whole blood, drawn within four weeks of study registration
• Serum PSA greater than or equal to 2ng/dl at registration
• At least four weeks since prior palliative radiation therapy and/or major surgery, and resolution of all toxic effects of prior therapy NCI CTCAE Grade less than or equal to one
• At least 18 years of age
• Adequate laboratory parameters
• Karnofsy Performance Status ≥ 60

Exclusion Criteria

You will be excluded from the trial if you meet any of the following criteria:

• History of or active central nervous system metastases
• The use of cytotoxic, biologic, or hormonal therapies within four weeks of study entry
• History of interstitial pneumonitis
• History of other prior malignancy in past five years, other than basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in sity, localized prostate cancer, or superficial bladder cancer
• Prior exposure to an mTOR inhibitor
• Presence of nephrotic syndrome as determined by clinical evaluation of 24 hour urine

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

For more information, contact Karla Morris at 919-668-8375.