Effect of Weight Loss on Prostate Cancer Pathology
N/A
N/A
Male
Obesity, Prostate Cancer
Trial Information
Effect of Weight Loss on Prostate Cancer Pathology
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Apoptotic index of the highest Gleason grade malignant epithelium in the radical prostatectomy specimen obtained after 8-weeks of the dietary intervention
Outcome Time Frame:
9-1-2013
Safety Issue:
No
Principal Investigator
William Aronson, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
VA Greater Los Angeles Healthcare System, West LA
Authority:
United States: Federal Government
Study ID:
CLIN-012-06F
NCT ID:
NCT00475982
Start Date:
January 2009
Completion Date:
July 2013
Related Keywords:
- Obesity
- Prostate Cancer
- Diet
- Insulin-like Growth Factor
- Weight Loss
- Obesity
- Prostatic Neoplasms
- Weight Loss
Name | Location |
|---|---|
| VA Greater Los Angeles Healthcare System, West LA | West Los Angeles, California 90073 |
