NCT01174953

High Risk Prostate Cancer Prevention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Kansas · Academic / Other
• Sex: Male
• Age: 55 Years – 95 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to study the molecular effects of the chemopreventative agent, finasteride, in combination with dietary soy supplementation in patients at high risk for the development of prostate cancer. Also, the investigators intend to create a large database with health information from men who are at high risk of developing prostate cancer, along with serum and tissue samples from those patients who are willing to provide tissue and serum samples.

Detailed description

Over 180,000 new cases of prostate cancer are diagnosed in the United States each year, making prostate cancer the most frequently diagnosed cancer in men. With an estimated 28,660 deaths occurring in 2008, prostate cancer is the second leading cause of cancer death in men. In Kansas, prostate cancer is also the most frequent cancer among men and ranked third (253 deaths in 2006) behind lung cancer (884 deaths in 2006) and colorectal cancer (273 deaths in 2006) in cancer related mortality. Despite the significant morbidity and mortality related to this disease, screening and treatment approaches remain controversial and there is significant morbidity related to the treatment of early stage disease. Preventative strategies and strategies which identify patients at highest risk are needed desperately. The goal of this proposal is to study the molecular effects of the chemopreventative agent, finasteride in combination with dietary soy supplementation in patients at high risk for the development prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	finasteride	Finasteride 5 mg once daily Soy 4 capsules twice daily (160 mg total)

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-08-04
• Last updated: 2014-01-01

Locations

2 sites across 1 country: United States