Status:
WITHDRAWN
Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Maryland Cigarette Restitution Fund
Conditions:
Prostate Adenocarcinoma
Obesity, Morbid
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The standard of care for obese men starting Androgen deprivation therapy (ADT) is physician based dietary and exercise counseling. Interventions to lessen the harmful effects of ADT are needed yet hav...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04331717
Start Date
November 16 2020
End Date
December 1 2023
Last Update
May 2 2022
Active Locations (1)
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1
Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21205