Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer (BASH-PC)

This is an interventional supportive care trial for Prostate Adenocarcinoma Read More

Inclusion Criteria:

• Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information (HIPAA authorization will be included in the informed consent)
• Males aged 18 years of age and above
• 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 (ie chemotherapy, anti-androgens)
• Prior local therapy with prostatectomy or radiotherapy (including brachytherapy) or both
• BMI >30 kg/m2 with a concurrent obesity related comorbidity

Obesity related comorbidity is defined as:

• hypertension (resting blood pressure >130/80 millimeters of mercury (mmHg) or being on medication to treat high blood pressure50),
• coronary artery disease (defined as prior myocardial infarction, elevated coronary artery calcium score, positive stress test history),
• dyslipidemia (triglyceride level of >150mg/dL or being on medicine to treat high triglycerides; HDL < 40mg/dL or being on medicine to treat cholesterol)51,
• diabetes (fasting glucose >126mg/dL, A1c > 6.5% or on medication for diabetes)52,
• pre-diabetes (fasting plasma glucose 100-125mg/dL)52,
• 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 3D CT angiography
• Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:

Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days Absolute neutrophil count (ANC) ≥ 1.0 x 109/L Platelet count ≥ 50 x 109/L Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) < 2.5 x institutional upper limit of normal Estimated Glomerular filtration rate (GFR) >60ml/min

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 NSAID use or daily smoking
• Hiatal hernia >5cm in size
• Active h.pylori infection (patients will be required to have negative h.pylori testing)
• Weight >400 pounds or BMI >45kg/m2
• 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 mm Hg 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
• 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