Effect of Weight Loss on Prostate Cancer Pathology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00475982
First received: May 17, 2007
Last updated: March 22, 2016
Last verified: March 2016
  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.

Condition Intervention
Obesity
Prostate Cancer
Behavioral: Weight Loss
Other: No Weight Loss Group

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: January 2009
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Weight Loss
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
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.

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475982

Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: William Aronson, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00475982     History of Changes
Other Study ID Numbers: CLIN-012-06F 
Study First Received: May 17, 2007
Last Updated: March 22, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Diet
Insulin-like Growth Factor
Weight Loss

Additional relevant MeSH terms:
Prostatic Neoplasms
Weight Loss
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 22, 2016