High Risk Prostate Cancer Prevention Study

NCT01174953 | Completed DMC

• 1 other identifier: 12052
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• provide a platform ongoing evaluation of novel preventive agents

  approximately 2 years

Study Arms (1)

Finasteride plus soy

OTHER

Finasteride and soy

Drug: finasteride

Interventions

finasteride DRUG

Finasteride 5 mg once daily Soy 4 capsules twice daily (160 mg total)

Also known as: Proscar, Propecia, isolavone

Finasteride plus soy

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• During time of study period, patients must agree not to take any new vitamin supplementation, soy or herbal supplement.
• Must not be receiving concurrent chemotherapy, radiation or hormonal therapy.
• No history of prior allergy and intolerability to soy-based products.
• Must not have been taking any soy supplementation, soy isoflavones or finasteride within 90 days prior to study enrollment.
• Must be able to safely be on study supplements for period of at least four months.
• 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.
• All patients must be willing to undergo prestudy and follow-up assessment, including prostate biopsies.

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas: lead

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Veterans Administration Medical Centenr

Kansas City, Missouri, 64128, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Finasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Peter J Van Veldhuizen, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: August 4, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 1, 2014

Record last verified: 2013-12

Locations

US (2)