ObesityWARRIORNCT03261271
Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
A study testing Weight Loss Program, Standardized educational flyer and Weight Maintenance Program in people with Obesity and Prostate Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Obesity, Prostate Cancer
- What is being tested?
- Weight Loss Program, Standardized educational flyer and Weight Maintenance Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2017to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Obesity, Prostate Cancer
- Being tested
- Weight Loss Program, Standardized educational flyer, Weight Maintenance Program
- Medical subject headings
- Obesity, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss ProgramBehavioural
Program involves one-on-one coaching, diet meal plan, and physical activity plan.
Standardized educational flyerBehavioural
The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.
Weight Maintenance ProgramBehavioural
Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss and Weight Maintenance | Experimental | 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. Receives: Behavioral: Weight Loss Program; Behavioral: Weight Maintenance Program |
| Control | Active comparator | Participants will receive a standardized educational flyer about a healthy diet and exercise. Receives: Behavioral: Standardized educational flyer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
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.
Measured: Change from Baseline to Month 6
Secondary outcomes (4)
Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors
Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio.
Measured: Change from Baseline to Month 6
Change in Weight
Body weight will be measured at participant study visits.
Measured: Change from Baseline to Month 6
Change in Body Composition
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.
Measured: Change from Baseline to Study End
Change in Quality of Life
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.
Measured: Change from Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start2 Nov 2017
- Primary completion28 Nov 2023
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Jill Hamilton-Reeves, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261271
- Sponsor's protocol ID
- STUDY00141060
- Other IDs
- RSG-17-050-01-NEC
- Acronym
- WARRIOR
- Status last verified
- Apr 2025
- First submitted
- 22 Aug 2017
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bechtel MD, Michel C, Srinivasan P, Chalise P, Parker WP, Mirza M, Thrasher B, Gibbs HD, DiGiovanni J, Hamilton-Reeves J. Impact of Weight Management on Obesity-Driven Biomarkers of Prostate Cancer Progression. J Urol. 2024 Apr;211(4):552-562. doi: 10.1097/JU.0000000000003849. Epub 2024 Feb 1.
PubMed 38299570
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03261271
- Acronym / sponsor ID
- WARRIOR / STUDY00141060
- Conditions
- Obesity, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Posted 26 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Loss and Weight Maintenance | Experimental | Behavioral: Weight Loss Program, Behavioral: Weight Maintenance ProgramParticipants 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. |
| Control | Active comparator | Behavioral: Standardized educational flyerParticipants will receive a standardized educational flyer about a healthy diet and exercise. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Loss ProgramProgram involves one-on-one coaching, diet meal plan, and physical activity plan. | Behavioural | Weight Loss and Weight Maintenance |
| Standardized educational flyerThe American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants. | Behavioural | Control |
| Weight Maintenance ProgramPost-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring. | Behavioural | Weight Loss and Weight Maintenance |
Primary outcome
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.
4 secondary outcomes
Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors
Time frame: Change from Baseline to Month 6
Change in Weight
Time frame: Change from Baseline to Month 6
Change in Body Composition
Time frame: Change from Baseline to Study End
Change in Quality of Life
Time frame: Change from Baseline to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38299570Bechtel MD, Michel C, Srinivasan P, Chalise P, Parker WP, Mirza M, Thrasher B, Gibbs HD, DiGiovanni J, Hamilton-Reeves J. Impact of Weight Management on Obesity-Driven Biomarkers of Prostate Cancer Progression. J Urol. 2024 Apr;211(4):552-562. doi: 10.1097/JU.0000000000003849. Epub 2024 Feb 1.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Hamilton-Reeves, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Program, Standardized educational flyer and Weight Maintenance Program in people with Obesity and Prostate Cancer, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors (time frame: Change from Baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.