View Clinical Trial (Medical Research Study)

Effect of Weight Loss on Prostate Cancer Pathology - NCT00475982-90073(Clinical Trial 170621)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  West Los Angeles
State:  
CA
Zip Code: 90073
Conditions: Obesity - Prostate Cancer
Purpose: The purpose of this study is to determine if weight loss prior to radical prostatectomy effects chemical substances in the blood stream and prostate tissue that may affect prostate cancer development and progression.
Study summary: Obesity is an epidemic, a major public health concern, and is a significant risk factor for progression and mortality from prostate cancer. Prior work in our laboratory in pre-clinical prostate cancer models and in obese men found that a low fat diet, exercise, and weight loss resulted in antiproliferative and pro-apoptotic effects on prostate cancer tissue through mechanisms related to the IGF-axis. We now propose to conduct a prospective, randomized clinical trial in overweight and obese men with prostate cancer undergoing radical prostatectomy to evaluate if weight loss prior to radical prostatectomy results in antiproliferative and pro-apoptotic effects in prostate cancer tissue. We will accomplish this aim by enrolling overweight and obese men with prostate cancer scheduled to undergo radical prostatectomy. Following informed consent, men will be randomized to either immediate radical prostatectomy or to an 8-week weight loss intervention group that will undergo a diet and exercise weight loss program followed by radical prostatectomy. Proliferation and apoptosis of prostate cancer cells in the prostatectomy specimen will be compared between the groups and relative to the baseline prostate needle biopsy specimens. Further studies will evaluate potential serum surrogate biomarkers that we developed in our laboratory (ex-vivo serum bioassays) and serum and tissue IGF-axis proteins that have previously been related to obesity, weight loss, and prostate cancer progression. The goal of our project will be to evaluate the potential anticancer effects of weight loss on prostate cancer tissue and to identify surrogate serum biomarkers that reflect antiproliferative and pro-apoptotic tissue effects and can be applied to future secondary prevention trials in overweight and obese prostate cancer survivors.
Criteria: Inclusion Criteria: 1. Subject is overweight or obese (BMI > 25 kg/m2) 2. Patient with pathologically confirmed adenocarcinoma of the prostate and has elected to undergo radical prostatectomy 3. Willing to delay radical prostatectomy for 5 to 8-weeks if randomized to the weight loss intervention group. 4. Able to adhere to physical activity intervention (able to walk for 30 minutes without rest) 5. Able to come to the VA for weight loss visits during the 5 to 8-wk study Exclusion Criteria: 1. Any one of the following: Gleason grade > 4+4, PSA > 20. 2. History of ever receiving androgen deprivation therapy, antiandrogen therapy, or finasteride 3. Prior prostate radiotherapy (external beam or brachytherapy) or prior cryotherapy 4. Diagnosis of diabetes mellitus and on insulin** 5. Current use of weight loss medications or enrolled in a diet/weight loss program 6. Current use of lycopene supplements*** Significant co-morbidities (i.e. cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) Cardiac pacemaker
Study is available at: VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, CA 90073
United States

Primary Contact:
William Aronson, MD
Email: william.aronson@va.gov

Secondary Contact:
William Aronson, MD
Email: william.aronson@va.gov
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.