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Official title Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
ClinicalTrials.gov ID: NCT06759701
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histologically confirmed adenocarcinoma of the prostate that is localized (no metastatic lesions or concerning lymph nodes 1cm or greater) based on...
- 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...
You likely can't join 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
See the full eligibility 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)
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.