Actively Recruiting
Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
Led by M.D. Anderson Cancer Center · Updated on 2026-02-27
30
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed localized adenocarcinoma of the prostate meeting NCCN intermediate risk criteria
- Clinical stage T2b-T2c or lower disease
- Gleason Grade group 2 or 3 on biopsy
- PSA level 20 ng/mL or less
- Planning radical prostatectomy and considered a surgical candidate
- Male adults between 30 and 75 years old
- Diagnosed with diabetes mellitus
- Overweight or obese, defined as BMI 27 kg/m2 or higher or waist circumference over 40 inches
- BMI 30 kg/m2 or higher, or BMI 27 kg/m2 or higher with at least one weight-related condition such as hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
You will not qualify if you...
- Prostate cancer meeting NCCN high or very high-risk criteria (pT3a or higher, Grade group 4 or 5)
- Metastatic disease on imaging
- Weight loss over 5 kg within 90 days before screening
- Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer
- Previous or planned obesity surgery or weight loss medication use within 90 days before screening
- Renal impairment with eGFR less than 30
- Known significant gastric emptying abnormality or chronic use of drugs affecting GI motility
- History of chronic or acute pancreatitis
- Active or unstable major depressive disorder or severe psychiatric disorder within last 2 years
- Cardiovascular events within 3 months before enrollment including heart attack, stroke, unstable angina, or heart failure hospitalization
- NYHA Functional Class IV heart failure
- Acute or chronic hepatitis or significant liver disease exceeding lab thresholds
- Family or personal history of medullary thyroid carcinoma or MEN type 2 syndrome
- Active or untreated malignancy other than prostate cancer within last 5 years
- Contraindication to GLP-1 receptor agonists
- History of drug or alcohol abuse, eating disorders, or psychiatric conditions affecting study compliance
- Marijuana use within 3 months before enrollment and unwillingness to abstain during study
- History of organ transplant except corneal transplant or awaiting transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Justin Gregg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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