Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)

A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer

This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.

Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.

Inclusion Criteria:

• Confirmed adenocarcinomas of the prostate.
• Evidence of metastatic disease
• Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan
• PSA level is greater or equal to 7 ng/ml.
• ECOG performance status less than or equal to 1

Exclusion Criteria :

• Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long).
• Prior chemotherapy for prostate cancer
• Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus.
• Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer
• Patient has pain related to prostate cancer that warrants the initiation of chemotherapy