Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer
Description
Primary Objectives: To determine the feasibility of a tirzepatide-assisted weight loss program prior to radical prostatectomy in a group of men diagnosed with intermediate risk prostate cancer, defined based on the following process measures: Enrollment (completion of 30 patient accrual within 2 years) Retention (completion of the study through the day of surgery, with ≥90% defined as successful) Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful). Secondary Objectives: 1. Determine differences in plasma and tumor sphingolipids followin…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate that is localized (no metastatic lesions or concerning lymph nodes 1cm or greater) based on prostate MRI and meets NCCN intermediate risk criteria (as follows): * Clinical T2b-T2c or lower disease * Gleason Grade group 2 or 3 on biopsy * PSA ≤20 ng/mL * Desires radical prostatectomy (open or robotic) for prostate cancer management and is a surgical candidate as determined by the treating urologic oncologist * Adult men \>30 and \< 75 years old * Currently diagnosed with Diabetes Mellitus and meet one of the…
Interventions
- DrugTirzepatide
Participants will perform weekly self-injection of tirzepatide as standard of care, following manufacturer instructions
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas