Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Dec 26, 2023
  • participants needed
    20
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 26 January 2021

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 have been limited. Exercise is one strategy that has been attempted however there is conflicting data as to whether or not exercise effectively improves body mass, results in sustained weight loss, improvements in metabolic risk profiles including glucose tolerance and lipid profiles in men starting ADT, or has any effect of progression of cancer. Dietary interventions have been attempted without clear improvement in weight, metabolic factors, quality of life or cancer progression. Bariatric arterial embolization (BAE), given it results in weight loss in obese men and women without cancer, may be able to stave off the harmful side effects of ADT by inducing weight loss. Therefore, the investigators hypothesize that Bariatric Arterial embolization (BAE), done prior to initiation of ADT, will mitigate the weight gain and metabolic side effects associated with ADT, by inducing weight loss of at least 5% in obese men with biochemical recurrent prostate cancer starting ADT.

The primary objective is to determine if BAE, done prior to ADT initiation in obese men (with obesity related comorbid condition) with biochemically recurrent prostate cancer, can induce 5% or greater weight loss at 6 months.

Details
Condition Morbid obesity, Prostate Adenocarcinoma, Adenocarcinoma of the Prostate, Adenocarcinoma of Prostate, severe obesity
Treatment Lupron, Bead Block 300-500 um, Weight Management, Weight Management
Clinical Study IdentifierNCT04331717
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Prostate Adenocarcinoma or Adenocarcinoma of the Prostate or Adenocarcinoma of Prostate or severe obesity or Morbid obesity?
Do you have any of these conditions: Prostate Adenocarcinoma or Adenocarcinoma of Prostate or severe obesity or Adenocarcinoma of the Prostate or Morbid obesity?
Do you have any of these conditions: Adenocarcinoma of the Prostate or Morbid obesity or severe obesity or Adenocarcinoma of Prostate or Prostate Adenocarcinoma?
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
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
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
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