Clinical trial · Interventional
Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
NCT03261271CI-TRIAL-00088507WARRIORcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standardized educational flyer | Behavioral | — | UNRESOLVED |
| Weight Loss Program | Behavioral | — | UNRESOLVED |
| Weight Maintenance Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Weight Loss and Weight Maintenance
- 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.
- interventionNames
- Behavioral: Weight Loss Program
- Behavioral: Weight Maintenance Program
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Participants will receive a standardized educational flyer about a healthy diet and exercise.
- interventionNames
- Behavioral: Standardized educational flyer
Primary outcomes (1)
- measure
- Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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.)
References
Publications (1)
- DERIVEDBechtel 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. PMID 38299570