NCT06759701招募中1 期
Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
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
详细描述
Primary Objectives:
To determine the feasibility of a tirzepatide-assisted weight loss program prior to radical prostatectomy in a group of men diagnosed with intermediate risk prostate cancer, defined based on the following process measures:
Enrollment (completion of 30 patient accrual within 2 years) Retention (completion of the study through the day of surgery, with ≥90% defined as successful) Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful).
Secondary Objectives:
- Determine differences in plasma and tumor sphingolipids following tirzepatide-based intervention
- Determine differences in markers of insulin and insulin signaling following tirzepatide-based intervention
- Determine differences in prostate, plasma and periprostatic fat inflammatory signaling following tirzepatide-based intervention
- Determine differences in tumor proliferation following tirzepatide-based intervention, including when stratified by obesity- and prostate cancer-associated SNPs and GLP-1 expression.
- Determine differences in ASCVD risk factors following tirzepatide-based intervention.
- Determine differences in other markers of cardiovascular risk.
- Determine changes in body scan as measured by DEXA scan after tirzepatide-based intervention
- Determine change in body weight following tirzepatide-based intervention.
- Determine changes in gut microbiome alpha and beta diversity following tirzepatide-based intervention.
- Determine rates of biochemical recurrence, receipt of salvage radiation therapy, and receipt of androgen deprivation therapy, stratified by prostatectomy pathology, after tirzepatidebased intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Tirzepatide
Experimental
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (1)
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