The purpose of this study is to measure the benefit of sorafenib in patients with a rising PSA after treatment with radiation therapy or surgery who are NOT receiving with androgen ablation therapy.
This is a placebo controlled double blind study of sorafenib versus placebo of in patients with high risk biochemical recurrence of prostate cancer. High risk characteristics include a short PSADT (\<9 months) or high Gleason score (\>8), characteristics, which correspond to a higher risk of prostate cancer specific mortality in patients with biochemical recurrence following radiation therapy or radical prostatectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
To compare the median PSA slope of patients with non-castrate, high risk biochemical recurrence of prostate cancer following definitive local therapy treated with Sorafenib for six months compared to those treated with placebo.
Time frame: 6 months
To determine the response rate based on PSA criteria and duration of PSA response.
Time frame: 6 months
To compare the time to PSA progression between the Sorafenib arm and the placebo arm.
Time frame: 6 months
To document the safety and tolerability of Sorafenib in this patient population.
Time frame: 6 months
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