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.
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. ]
|Date last updated at source||2016-04-14|
|Study start date||2009-09-01|
|Estimated primary completion date||2010-08-01|