Effect of Weight Loss on Prostate Cancer Pathology

Completed · Not applicable

Conditions studied: Obesity, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00475982

Run by

VA Office of Research and Development

People needed

44

Starts

2009-01-01

Expected to finish

2016-03-01

Last updated by the study team

2019-01-31

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subject is overweight or obese (BMI > 25 kg/m2)
• Patient with pathologically confirmed adenocarcinoma of the prostate and has elected to undergo radical prostatectomy
• Willing to delay radical prostatectomy for 5 to 8-weeks if randomized to the weight loss intervention group.
• Able to adhere to physical activity intervention (able to walk for 30 minutes without rest)
• Able to come to the VA for weight loss visits during the 5 to 8-wk study

You may not qualify if…

• Any one of the following: Gleason grade > 4+4, PSA > 20.
• History of ever receiving androgen deprivation therapy, antiandrogen therapy, or finasteride
• Prior prostate radiotherapy (external beam or brachytherapy) or prior cryotherapy
• Diagnosis of diabetes mellitus and on insulin**
• Current use of weight loss medications or enrolled in a diet/weight loss program
• Current use of lycopene supplements*** Significant co-morbidities (i.e. cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) Cardiac pacemaker

Where it is running

• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States

Full record on ClinicalTrials.gov

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