High Risk Prostate Cancer Prevention Study

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: finasteride

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Veterans Administration Medical Centenr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Based on the PSA, DRE and Family history of prostate cancer patients will be risk stratified using Prostate Cancer Risk Calculator. Must have at least 25% chance of prostate cancer development as assessed by the prostate cancer risk calculator.
2. During time of study period, patients must agree not to take any new vitamin supplementation, soy or herbal supplement.
3. Must not be receiving concurrent chemotherapy, radiation or hormonal therapy.
4. No history of prior allergy and intolerability to soy-based products.
5. Must not have been taking any soy supplementation, soy isoflavones or finasteride within 90 days prior to study enrollment.
6. Must be able to safely be on study supplements for period of at least four months.
7. All patients must have been informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
8. All patients must be willing to undergo prestudy and follow-up assessment, including prostate biopsies.

Exclusion Criteria:

1. Patients diagnosed with prostate cancer on initial biopsy
2. Patients with any active malignancy
3. Receiving any concurrent chemotherapy, hormonal therapy or radiation
4. Patient not compliant with treatment for at least 4 months
5. Patients with history of deep vein thrombosis, myocardial infarction, coronary artery disease,and cerebrovascular accident in the last 6 months will also be excluded.
6. Patients on active anticoagulation will be excluded.
7. Patients with liver function tests more than 2 levels of upper limit of normal
8. Patients who develop more than grade 2 toxicity will also be removed from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Finasteride plus soy; Finasteride and soy	Drug: finasteride; Finasteride 5 mg once daily Soy 4 capsules twice daily (160 mg total); Other Names: Proscar; Propecia; isolavone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biomarkers will be identified to help predict future prostate cancer risks and patients likely to benefit from preventive strategies	2 years from completion of enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
provide a platform ongoing evaluation of novel preventive agents	approximately 2 years

Collaborators and Investigators

• Sponsor: University of Kansas

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 4, 2010

Study Record Updates

• Last Update Posted (Estimate): January 1, 2014
• Last Update Submitted That Met QC Criteria: December 30, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride
• Other Study ID Numbers: 12052