RecruitingDiabetesProstate Cancer
Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
Eligible age
18+ yrs
Accepts
Men
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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
Sponsor: M.D. Anderson Cancer Center
You may qualify if…
- ✓ 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 following criteria for overweight or obesity:
- ✓ Body Mass Index (BMI) greater than or equal to 27 kg/m2
You may not qualify if…
- ✕ Prostate cancer that meets factors as part of NCCN high and very high-risk criteria (as follows):
- ✕ pT3a or higher disease
- ✕ Grade group 4 or 5 adenocarcinoma of prostate
- ✕ Presence of metastatic disease on imaging
- ✕ A history of intentional or unintentional weight loss of more than 5kg within 90 days of screening
- ✕ Any prior androgen deprivation, chemotherapy, surgery, or radiation for PCa
- ✕ Previous or planned surgical treatment for obesity or use of a medication that promotes weight loss within 90 days before screening
- ✕ Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 as determine using standard MD Anderson laboratory measures
Where it's recruiting
Texas
Houston
Source: ClinicalTrials.gov · NCT06759701 · last updated 2026-09-25