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Sorafenib for Metastatic Prostate Cancer

Name of the Trial

Phase II Study of Sorafenib in Patients With Metastatic Androgen-Independent Prostate Cancer. See the protocol summary.

Principal Investigator

Dr. William Dahut, NCI Center for Cancer Research

Why This Trial Is Important

Dr. William Dahut
Dr. William Dahut
Principal Investigator

Prostate cancer cells often grow in response to hormones called androgens, which are naturally produced by the body. In most men with prostate cancer that has spread (metastasized), treatment to suppress these hormones is initially very effective in controlling cancer cell growth. However, over time, prostate cancer acquires the ability to grow without the help of hormones. This is called androgen-independent prostate cancer.

Many new drugs are currently being tested for the treatment of metastatic, androgen-independent prostate cancer. Sorafenib (Nexavar) is a type of anticancer drug that belongs to a class of drugs called small-molecule inhibitors. Small-molecule inhibitors block the activity of proteins in cancer cells that help promote cell division and survival.

Sorafenib inhibits the activity of at least three cancer-cell proteins involved in cell signaling-the transmission of information within a cell or between cells. The inhibition of multiple signaling proteins blocks both tumor-cell division and the growth of new blood vessels (angiogenesis) that feed the tumor.

"In the laboratory, sorafenib had activity against both signal transduction and angiogenesis in prostate cancer," explained Dr. Dahut. "We believe that angiogenesis is an important target in prostate cancer. Patients who have more vascular tumors at the time of initial diagnosis are more likely to eventually develop metastatic disease."

Contact Information

This study is no longer accepting new patients. To locate other clinical trials for prostate cancer, search the NCI's list of clinical trials or call the NCI's Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.

Published Results

Aragon-Ching JB, Jain L, Gulley JL, et al.: Final analysis of a phase II trial using sorafenib for metastatic castration-resistant prostate cancer. BJU Int 103 (12): 1636-40, 2009.[PUBMED Abstract]

Dahut WL, Scripture C, Posadas E, et al.: A phase II clinical trial of sorafenib in androgen-independent prostate cancer. Clin Cancer Res 14 (1): 209-14, 2008.[PUBMED Abstract]

Posadas EM, Gulley J, Arlen PM, et al.: A phase II study of BAY 43-9006 in patients with androgen-independent prostate cancer (AIPC) with proteomic profiling. [Abstract] J Clin Oncol 23 (Suppl 16): A-4762, 443s, 2005.

  • Posted: January 23, 2007
  • Updated: February 9, 2010