RECRUITING

Pre-surgical Tirzepatide-assisted Weight Loss in Men With Diabetes and Prostate Cancer: A Pilot Feasibility Study

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Pre-surgical Tirzepatide-assisted Weight Loss in Men With Diabetes and Prostate Cancer: A Pilot Feasibility Study

Quick Facts

Study Start:2025-07-02

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06759701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult men \>30 and \< 75 years old * Meet one of the following criteria for overweight or obesity: * Willingness to comply with all study procedures and scheduled visits, including motivation and willingness (as determined by the investigator) to self-inject medication required in the study * Currently diagnosed with Diabetes Mellitus	* 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 lifetime history of a suicide attempt * 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.

Inclusion Criteria

Exclusion Criteria

* Adult men \>30 and \< 75 years old
* Meet one of the following criteria for overweight or obesity:
* Willingness to comply with all study procedures and scheduled visits, including motivation and willingness (as determined by the investigator) to self-inject medication required in the study
* Currently diagnosed with Diabetes Mellitus

* 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 lifetime history of a suicide attempt
* 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.

Contacts and Locations

Study Contact

Justin Gregg, MD

CONTACT

(713) 792-3250

jrgregg@mdanderson.org

Principal Investigator

Justin Gregg, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Justin Gregg, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-02

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-07-02

Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

Diabetes
Prostate Cancer