Effect of Weight Loss on Prostate Cancer Pathology

NCT00475982 | Completed Results

• 1 other identifier: CLIN-012-06F
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Prostate Cancer

Keywords

Diet; Insulin-like Growth Factor; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Apoptotic Index of the Highest Gleason Grade Malignant Epithelium in the Radical Prostatectomy Specimen Obtained After 8-weeks of the Dietary Intervention

  The primary objective is to compare the mean apoptotic index in the radical prostatectomy malignant epithelium between the Weight Loss Group and the Control Group-No Weight Loss. The apoptotic index will be measured in the malignant epithelium with the highest Gleason grade. TUNEL staining was used to identify these apoptotic cells and measure the apoptotic index, which is the percent of cells stained from the sample.

  8 weeks

Secondary Outcomes (6)

• Proliferative Index in Prostate Cancer Epithelium Specimen

  8 weeks

• Change in Serum IGF-related Analytes: IGF-1

  baseline and post-intervention

• Change in Serum IGF-related Analytes: IGFBP-1

  baseline and post-intervention

• Ex-vivo Mitogenic and Apoptotic Activity of Patient Sera on LNCaP Cells

  baseline and post-intervention

• Change in Body Weight

  baseline and post-intervention

Study Arms (2)

Arm 1: Weight Loss

EXPERIMENTAL

Weight Loss Group

Behavioral: Weight Loss

Arm 2: No Weight Loss

ACTIVE COMPARATOR

No Weight Loss Group

Other: No Weight Loss Group

Interventions

Weight Loss 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 1: Weight Loss

No Weight Loss Group 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.

Arm 2: No Weight Loss

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Obesity; Prostatic Neoplasms; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Body Weight Changes

Results Point of Contact

• Title: William Aronson, MD
• Organization: VA Medical Center Greater Los Angeles Healthcare System

waronson@ucla.edu

3102683446

Study Officials

• William Aronson, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: January 1, 2009
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 31, 2019
• Results First Posted: January 31, 2019

Record last verified: 2018-08

Locations

US (1)