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Completed

NCT Number: NCT03261271

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

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Weight Loss Program

Behavioral

Program involves one-on-one coaching, diet meal plan, and physical activity plan.

Standardized educational flyer

Behavioral

The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.

Weight Maintenance Program

Behavioral

Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.

Primary outcomes

  1. Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors

    Time frame: Change from Baseline to Month 6

    Impact will be measured by changes in specific blood immune biomarker monocytic myeloid-derived suppressor cells (mMDSCs). The absolute number of cell counts were calculated using the lymphocyte count abstracted from the complete blood count with differential.

Secondary outcomes

  1. Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors

    Time frame: Change from Baseline to Month 6

    Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio.

  2. Change in Weight

    Time frame: Change from Baseline to Month 6

    Body weight will be measured at participant study visits.

  3. Change in Body Composition

    Time frame: Change from Baseline to Study End

    Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA). Change in percent body fat will be analyzed between groups from baseline to study end.

  4. Change in Quality of Life

    Time frame: Change from Baseline to Month 6

    Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Acronym: WARRIOR

Important dates

Study start
2017
Primary completion
2023
Study completion
2025
First posted
Aug 24, 2017
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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