Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well a weight-loss program using tirzepatide works before surgery to remove the prostate. It is for men with excess weight and prostate cancer in the middle-risk group that has not spread.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men older than 30 and younger than 75.
- A tissue sample confirms prostate cancer. An MRI shows no cancer spread or concerning lymph nodes 1 cm or larger.
- Cancer meets the study’s middle-risk rules: stage T2b–T2c or lower, grade group 2 or 3, and PSA of 20 or less. Stage and grade describe the cancer; PSA is a blood test.
- Want surgery to remove the prostate and are judged fit for surgery by the cancer surgeon.
- Meet at least one weight rule: BMI of 30 or more; diabetes with BMI of 27 or more or waist over 40 inches; or BMI of 27 or more with a weight-related health problem. BMI is a weight measure based on height.
- For the last weight rule, health problems may include high blood pressure, unhealthy blood fats, blocked breathing during sleep, or heart or blood vessel disease.
Who can't join
- High-risk prostate cancer, cancer that has spread, or past prostate cancer treatment with hormone-lowering drugs, chemotherapy, surgery, or radiation.
- Lost more than 5 kg (about 11 pounds) in the past 90 days; had or plan weight-loss surgery; or used weight-loss medicine in the 90 days before screening.
- Severe kidney problems; major problems with food leaving the stomach; regular medicines that affect gut movement; or past inflammation of the pancreas.
- A heart attack, stroke, unstable chest pain, or hospital stay for heart failure in the past 3 months; the most severe class of heart failure; or certain liver diseases or high liver blood tests. Fatty liver disease may be allowed.
- A personal or family history of medullary thyroid cancer or MEN type 2, a condition that causes tumors in glands; certain other active, untreated, or recently treated cancers; or an organ transplant or waiting for one. Cornea transplants are allowed.
- Severe or unstable depression or another serious mental health condition in the past 2 years. Stable depression or general anxiety may be allowed if medicines meet study rules.
- A condition that makes GLP-1 medicines unsafe, such as an allergy, or any condition that could prevent following the study plan, such as drug or alcohol misuse or an eating disorder.
- Marijuana use in the past 3 months and unwillingness to stop during the study. Participants must also avoid cannabidiol (CBD) oil during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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.
Study sites (1)
TX
- The University of Texas M. D. Anderson Cancer Center · Houston, TX 77030Justin Gregg, MD · Study contact · 713-792-3250 · jrgregg@mdanderson.orgJustin Gregg, MD · Principal investigatorMore trials in Houston