Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer

Rationale:
Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Purpose:
This phase II trial is studying the side effects of everolimus and to see how well it works as first-line therapy in treating patients with prostate cancer.

Primary Outcome Measures:

• Progression-free survival [ Time Frame: at 12 weeks ]

Secondary Outcome Measures:

• Progression-free survival [ Time Frame: at 24 weeks ]
• Progression-free survival [ Time Frame: from start of treatment until progression or death of any cause ]
• from start of treatment until progression or death of any cause, whereas it will be censored at the last follow-up visit or initiation of a different treatment.

• Adverse events according to NCI CTCAE v. 3.0 [ Time Frame: from start of treatment until progression or death of any cause ]
• PSA response [ Time Frame: 50% and 30%, best and at 12 weeks ]
• Changes in PSA-doubling time [ Time Frame: Time points for later calculations include: after 12 weeks, after 24 weeks and at best PSA response ]
• Tumor assessment of measurable disease according to RECIST v1.1 criteria [ Time Frame: The first assessment will be performed after 12 weeks of treatment, or earlier if clinically indicated. ]
• Tumor assessment of bone lesions [ Time Frame: at 12 weeks. ]