Tirzepatide for Weight Loss Before Prostate Surgery
Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
Recruiting
Early Phase 1Interventional Study
DiabetesProstate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for
This trial is looking for men with intermediate risk prostate cancer who are also overweight or obese. Participants will take part in a weight loss program using tirzepatide before their prostate surgery.
Are You a Good Fit for This Trial?
Rules you outSevere liver diseaseDepressionHeart attackStroke
You may be able to join if
I am a man aged 30 to 75 years old.
I have been diagnosed with prostate cancer that is localized and meets specific risk criteria.
I have diabetes.
I have a body mass index (BMI) of 27 or higher.
I want to have surgery to treat my prostate cancer.
You may not be able to join if
I have prostate cancer that is high risk.
I have metastatic disease.
I have lost more than 5 kg in the last 90 days.
I have taken weight loss medications in the last 90 days.
I have severe liver disease.
I have a history of significant depression or other severe psychiatric disorders.
I have had a heart attack or stroke in the last 3 months.
I have had any organ transplant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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Status
Eligibility Criteria
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 gro…
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 following criteria for overweight or obesity:
* Body Mass Index (BMI) greater than or equal to 27 kg/m2
* Waist circumference (\> 40 inches) -or-
* Currently have a BMI greater or equal to 30 kg/m2 -or-
* Currently have a BMI greater or equal to 27 kg/m2 with at least one weight-related condition, defined as one or more of the following:
* Hypertension: treated or with systolic blood pressure (SBP) ≥130 mmHg or diastolic blood pressure ≥80 mmHg
* Dyslipidemia: treated or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) \<40mg/dL (1.0 mmol/L)
* Obstructive sleep apnea
* Cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure)
Exclusion Criteria:
* 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
* Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility
* Have had a history of chronic or acute pancreatitis
* Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years
* Note: Patients with MDD or generalized anxiety disorder whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications
* Have any of the following cardiovascular conditions within 3 months prior to study enrollment: acute myocardial infarction (MI), cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF)
* Have NYHA Functional Classification IV CHF
* Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of the following, as determined by the central laboratory during screening: - alanine aminotransferase (ALT) level \>3.0X the upper limit of normal (ULN) for the reference range or - alkaline phosphatase (ALP) level \>1.5X the ULN for the reference range or - total bilirubin level \>1.2X the ULN for the reference range (except for cases of known Gilbert's Syndrome) Note: Participants with nonalcoholic fatty liver disease are eligible to participate in this trial if their ALT level is ≤3.0X the ULN for the reference range
* Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix), other than prostate cancer, for less than 5 years
* Have any other condition not listed in this section (for example, hypersensitivity or intolerance) that is a contraindication to GLP-1R agonists
* Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
* Have history of use of marijuana within 3 months of enrollment and unwillingness to abstain from marijuana use during the trial. Participants should also refrain from use of cannabidiol oil for the duration of the study
* Have had a transplanted organ (corneal transplants \[keratoplasty\] allowed) or awaiting an organ transplant.
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