Effect of Weight Loss on Prostate Cancer Pathology

NCT ID: NCT00475982

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

Detailed Description

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 the investigators' 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. The investigators 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. The investigators 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 the investigators developed in the investigators' 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 the investigators' 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.

Conditions

Obesity; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1: Weight Loss

Weight Loss Group

Group Type: EXPERIMENTAL

Weight Loss

Intervention Type: BEHAVIORAL

Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.

Arm 2: No Weight Loss

No Weight Loss Group

Group Type: ACTIVE_COMPARATOR

No Weight Loss Group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Aronson, MD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Locations

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: VA GLA ICF

View Document

Document Type: Informed Consent Form: UCLA ICF

View Document

Other Identifiers

CLIN-012-06F

Identifier Type: -

Identifier Source: org_study_id