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High Risk Prostate Cancer Prevention Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01174953
First received: July 26, 2010
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: finasteride

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: High Risk Prostate Cancer Prevention Study

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Biomarkers will be identified to help predict future prostate cancer risks and patients likely to benefit from preventive strategies [ Time Frame: 2 years from completion of enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • provide a platform ongoing evaluation of novel preventive agents [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: July 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 95 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174953

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Veterans Administration Medical Centenr
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Peter J Van Veldhuizen, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01174953     History of Changes
Other Study ID Numbers: 12052
Study First Received: July 26, 2010
Last Updated: December 30, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Kansas:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014