High Risk Prostate Cancer Prevention Study

Prostate Cancer Clinical Trial

Official title:

High Risk Prostate Cancer Prevention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174953
• Other study ID #: 12052
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: December 30, 2013
• Start date: July 2010
• Est. completion date: March 2013

Study information

• Verified date: December 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 95 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• finasteride
Finasteride 5 mg once daily Soy 4 capsules twice daily (160 mg total)

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Veterans Administration Medical Centenr	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	provide a platform ongoing evaluation of novel preventive agents		approximately 2 years	No