Effect of Weight Loss on Prostate Cancer Pathology
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Effect of Weight Loss on Prostate Cancer Pathology|
- Apoptotic index of the highest Gleason grade malignant epithelium in the radical prostatectomy specimen obtained after 8-weeks of the dietary intervention [ Time Frame: 9-1-2013 ] [ Designated as safety issue: No ]
- Proliferative index in prostate cancer epithelium specimen, change in apoptotic & proliferative indices of malignant epithelium between the diagnostic prostate needle biopsy & corresponding radical prostatectomy, change in serum IGF-related analytes [ Time Frame: 9-1-2013 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Weight Loss Group
Behavioral: Weight Loss
Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
Active Comparator: Arm 2
No Weight Loss Group
Other: No Weight Loss Group
These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475982
|United States, California|
|VA Greater Los Angeles Healthcare System, West LA|
|West Los Angeles, California, United States, 90073|
|Principal Investigator:||William Aronson, MD||VA Greater Los Angeles Healthcare System, West LA|