Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy (WARRIOR)

University of Kansas

Status: Completed

Conditions: Obesity; Prostate Cancer

Treatments: Behavioral: Standardized educational flyer; Behavioral: Weight Maintenance Program; Behavioral: Weight Loss Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03261271

RSG-17-050-01-NEC (Other Grant/Funding Number)

STUDY00141060

Details and patient eligibility

About

The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.

Enrollment: 40 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or T2)
• Body Mass Index (BMI) 25-45 kg/m2
• Has internet access

Exclusion criteria

• History of 5 alpha reductase inhibitors prior 3 months
• History of radiation therapy for cancer treatment
• Taking active cancer treatment
• Undergoing salvage therapy
• Castration-resistant PCa
• Evidence of metastasis
• Evidence of biochemical recurrence
• High risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Weight Loss and Weight Maintenance

Experimental group

Description:

Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery.

Treatment:

Behavioral: Weight Loss Program

Behavioral: Weight Maintenance Program

Control

Active Comparator group

Description:

Participants will receive a standardized educational flyer about a healthy diet and exercise.

Treatment:

Behavioral: Standardized educational flyer