NCT00694291

Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer

Phase II Double Blind Randomized Placebo Controlled Study of Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib	400 mg orally twice daily
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-06-01
• First posted: 2008-06-10
• Last updated: 2015-03-06

Locations

1 site across 1 country: United States