Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer

NCT04331717 | Withdrawn Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: J1943IRB00207275
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Adenocarcinoma; Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• Number of participants who experience at least 5 percent weight loss

  Number of participants who experience at least 5 percent weight loss at 6 months after BAE.

  At 6 months

Secondary Outcomes (4)

• Number of adverse events

  Up to 6 months

• Change in Blood Pressure

  Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48

• Change in Respiratory Rate

  Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48

• Change in Oxygen saturation

  Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48

Other Outcomes (25)

• Time to disease progression

  Up to 51 weeks

• Change in C-Reactive Protein level

  At 12 weeks, 24 weeks, 36 weeks, and 48 weeks

• Change in Erythrocyte Sedimentation Rate

  At 12 weeks, 24 weeks, 36 weeks, and 48 weeks

Study Arms (1)

Diet and exercise with BAE

EXPERIMENTAL

After enrollment in the clinical trial, all men will be enrolled in diet and exercise counseling through the weight management program for a total of 4 weeks. If participants lose \>5 pounds of total body weight from weight management alone in the first 4 weeks, these participants will be excluded from study and will not undergo BAE but will be encouraged to continue with weight management. Those still enrolled will undergo BAE. Within 7 days of BAE, men will be given ADT (lupron subcutaneous injection).

Device: Bead Block 300-500 um; Behavioral: Weight Management; Drug: Lupron

Interventions

Bead Block 300-500 um DEVICE

These patients will undergo embolization with 300-500µm Bead Block particles.

Diet and exercise with BAE

Weight Management BEHAVIORAL

All participants will be enrolled in weight management through the Johns Hopkins Weight Management Center. During weeks -4 through 0, participants will be required to go to weekly visits. Weight management will include counseling on diet, exercise and behavior change. Food programs, pharmacotherapy and other procedures will not be utilized.

Diet and exercise with BAE

Lupron DRUG

22.5 mg will be given as a single intramuscular or subcutaneous injection once every 12 weeks according to the standard of care for prostate cancer. If leuprolide acetate, 22.5 mg for 3-month administration is not available, a suitable substitute may be allowed upon approval by the principle investigator

Diet and exercise with BAE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Maryland Cigarette Restitution Fund: collaborator

Study Sites (1)

Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Catherine Marshall, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: November 16, 2020
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

US (1)