Bariatric Arterial Embolization for Weight Loss in Patients with Prostate Cancer Who Are Starting Hormonal Therapy

Inclusion Criteria

• Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information (HIPAA authorization will be included in the informed consent)
• Males aged > 21 years of age but < 70 years of age
• Histological proof of adenocarcinoma of the prostate
• Non-metastatic disease by computed tomography (CT), magnetic resonance imaging (MRI) or nuclear medicine (NM) bone scan. Patients must have CT abdomen/pelvis with contrast prior to enrollment
• Metastatic disease may be permitted if NOT starting on any concomitant therapy (i.e. chemotherapy, anti-androgens)
• Prior local therapy with prostatectomy or radiotherapy (including brachytherapy) or both
• Body mass index (BMI) >= 35 kg/m^2 with a concurrent obesity related comorbidity * Obesity related comorbidity is defined as: ** Hypertension (resting blood pressure > 130/80 mmHg or being on medication to treat high blood pressure) ** Coronary artery disease (defined as prior myocardial infarction, elevated coronary artery calcium score, positive stress test history) ** Dyslipidemia (triglyceride level of >= 150 mg/dL or being on medicine to treat high triglycerides; high-density lipoprotein (HDL) < 40 mg/dL or being on medicine to treat cholesterol), ** Diabetes (fasting glucose >=126 mg/dL, A1c >= 6.5% or on medication for diabetes) ** Pre-diabetes (fasting plasma glucose 100-125 mg/dL) ** Elevated waist circumference (>= 40 inches in men) ** Obstructive sleep apnea, ** Arthritis, or ** Non-alcoholic steatohepatitis
• Prior salvage or adjuvant radiation therapy is allowed but must have been completed at least 3 months prior to enrollment
• Non-castrate levels of testosterone (>= 50 ng/dL required)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
• Vascular anatomy (including celiac, hepatic and gastric arteries) that in the opinion of the interventional radiologist is amenable to bariatric embolization as assessed on 3-dimensional (3D) CT angiography
• Hemoglobin >= 10.0 g/dL with no blood transfusion in the past 28 days (within 28 days prior to administration of study treatment)
• Absolute neutrophil count (ANC) >= 1.0 x 10^9/L (within 28 days prior to administration of study treatment)
• Platelet count >= 50 x 10^9/L (within 28 days prior to administration of study treatment)
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)
• Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) < 2.5 x institutional upper limit of normal (within 28 days prior to administration of study treatment)
• Estimated glomerular filtration rate (GFR) > 60ml/min (within 28 days prior to administration of study treatment)

Exclusion Criteria

• Prior hormonal therapy within 12 months of enrollment
• Planned concurrent cytotoxic chemotherapy or antiandrogens (ex. bicalutamide, abiraterone acetate, enzalutamide or any investigational agent
• Contraindication to the use of leuprolide, such as a previous hypersensitivity reaction to an luteinizing hormone-releasing hormone (LHRH) analogue or any of the excipients in the leuprolide injection
• Prior history of gastric, pancreatic, hepatic and/or splenic surgery
• Prior radiation therapy to the upper abdomen (pelvic radiation is not an exclusion)
• Prior embolization to the stomach, spleen or liver
• Cirrhosis or known portal venous hypertension
• Active peptic ulcer disease or significant risk factors for peptic ulcer disease including daily nonsteroidal anti-inflammatory drugs (NSAID) use or active smokers or those who quit within the last 5 years
• Hiatal hernia >= 5 cm in size
• Active h.pylori infection (patients will be required to have negative h.pylori testing)
• Weight >= 400 pounds or BMI >= 45 kg/m^2
• Known aortic arch pathology such as aneurysm or dissection
• Major comorbidity that precludes procedure including significant cardiovascular disease or peripheral arterial disease including the following: * Myocardial infarction within 6 months before screening * Unstable angina within 3 months before screening * New York Heart Association class III or IV congestive heart failure or a history of New York Heart Association class III or IV congestive heart failure unless a screening echocardiogram or multi-gated acquisition scan performed within 3 months before the randomization date demonstrates a left ventricular ejection fraction >= 45% * History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) * Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mm Hg at screening * Peripheral arterial stenting or bypass procedure within 6 months before screening * Active claudication
• Diabetes with A1c > 7% or requiring medication other than metformin. Subjects with diabetes will have their medications managed by a diabetes specialist, per routine care, as defined by American Diabetes Association guidelines
• Known gastric motility dysfunction
• Preexisting chronic abdominal pain
• Positive stool occult study
• Inflammatory bowel disease
• Known history of allergy to iodinated contrast media
• American Society of Anesthesiology (ASA) physical status classification system class 4 of 5 (very high risk surgical candidates: class 4 = incapacitating disease that is a constant threat to life) at the time of screening for enrollment
• Any condition in which the principle investigator feels participation in the trial would put the patient and undue risk
• Active substance abuse or alcoholism
• Certain psychiatric disorders like schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual’s ability to understand the proposed therapy