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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331717
Recruitment Status : Withdrawn (accrual on hold)
First Posted : April 2, 2020
Last Update Posted : May 2, 2022
Sponsor:
Collaborator:
Maryland Cigarette Restitution Fund
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE March 31, 2020
First Posted Date  ICMJE April 2, 2020
Last Update Posted Date May 2, 2022
Actual Study Start Date  ICMJE November 16, 2020
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
Number of participants who experience at least 5 percent weight loss [ Time Frame: At 6 months ]
Number of participants who experience at least 5 percent weight loss at 6 months after BAE.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
  • Number of adverse events [ Time Frame: Up to 6 months ]
    Number of adverse events will be assessed to determine if there are any increased adverse events in men with prostate cancer undergoing BAE.
  • Change in Blood Pressure [ Time Frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48 ]
    Blood pressure (mmHg) will be assessed for changes over the specified time points.
  • Change in Respiratory Rate [ Time Frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48 ]
    Respiratory rate in breaths per minute will be assessed for changes over the specified time points.
  • Change in Oxygen saturation [ Time Frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48 ]
    Oxygen saturation (percentage) will be assessed for changes over the specified time points.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 31, 2020)
  • Time to disease progression [ Time Frame: Up to 51 weeks ]
    The amount of Time (months) till prostate-specific antigen (PSA) progression which will be assessed by PSA blood test at screening, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. With PSA progression defined as first PSA increase that is 25% and 2ng/mL above the nadir, and which is confirmed by a second value at least 3 weeks later, or the amount of Time till radiographic progression which will be assessed by RECIST v1.1 using conventional CT chest/abd/pelvis or NM Bone scan. Radiographic progression will be defined as visceral and nodal disease or at least 2 new bone lesions.
  • Change in C-Reactive Protein level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    C-Reactive Protein (CRP) levels in mg/dL.
  • Change in Erythrocyte Sedimentation Rate [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Erythrocyte Sedimentation Rate (ESR) in millimeters per hour.
  • Change in Interleukin 6 level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Interleukin 6 (IL-6) levels in pg/ml.
  • Change in Interleukin 8 level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Interleukin 8 (IL-8) levels in pg/mL.
  • Change in Tumor Necrosis Factor Alpha level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Tumor Necrosis Factor Alpha (TNF-α) levels in pg/mL.
  • Change in Interleukin 1 alpha level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Interleukin 1 alpha (IL-1α) levels in pg/mL.
  • Change in Interleukin 1 beta level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Interleukin 1 beta (IL-1β) levels in pg/mL.
  • Change in Ghrelin level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Ghrelin levels in pg/mL.
  • Change in leptin level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Leptin levels in percentage.
  • Change in active Glucagon-like Peptide-1 level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Active Glucagon-like Peptide-1 (GLP-1) levels in pmol/L.
  • Change in Peptide YY level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Peptide YY (PYY) levels in pmol/L.
  • Change in Insulin-like growth factor 1 level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Insulin-like growth factor 1 (IGF-1) levels in ng/mL.
  • Change in Adiponectin level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Adiponectin levels in mL.
  • Change in microbiome [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    To evaluate changes in the microbiome of men with prostate cancer before and after undergoing BAE and starting ADT.
  • Change in high density lipoprotein level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
    High density lipoprotein (HDL) levels in mg/dL.
  • Change in triglycerides level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Triglycerides level in mg/dL.
  • Change in fasting glucose level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks and 48 weeks ]
    Fasting glucose (mg/dL) will be assessed at specified time points for any changes. Fasting glucose within normal is <126 mg/dL.
  • Change in hemoglobin A1c level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Hemoglobin A1c levels in percentage will be assessed at 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
  • Change in low density lipoprotein level [ Time Frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Low density lipoprotein (LDL) levels in mg/dL.
  • Change in Quality of life as assessed by Abbreviated version of the medical outcomes, short-form 36 (SF-12) [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Quality of Life scored on a scale from 0 to 48, higher scores representing highest level of functioning possible.
  • Change in Quality of life as assessed by Impact of Weight on Quality of Life Questionnaire (IWQOL) [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Impact of Weight on Quality of Life all 31 questions are scored on a scale from 1 to 5, higher scores representing poorer quality of life.
  • Change in Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
  • Change in Quality of life as assessed by Expanded Prostate Cancer Index Composite-26 question assessment (EPIC-26) [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    All questions are scored on a scale from 0 to 100. The total score from all of the questions answered is divided by the total number of the questions answered yielding a global score from 0-100 with 100 representing the highest level of functioning possible.
  • Change in Fatigue as assessed by the Brief Fatigue Inventory (BFI) [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
    Fatigue Rated by 9 each item on a 0-10 and 1 on a yes no scale, higher scores representing more fatigue.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer
Official Title  ICMJE BASH-PC: Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Prostate Adenocarcinoma
  • Obesity, Morbid
Intervention  ICMJE
  • Device: Bead Block 300-500 um
    These patients will undergo embolization with 300-500µm Bead Block particles.
  • Behavioral: Weight Management
    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.
  • Drug: Lupron
    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
Study Arms  ICMJE Experimental: Diet and exercise with BAE
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).
Interventions:
  • Device: Bead Block 300-500 um
  • Behavioral: Weight Management
  • Drug: Lupron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 29, 2022)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2020)
20
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04331717
Other Study ID Numbers  ICMJE J1943
IRB00207275 ( Other Identifier: JHM IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Maryland Cigarette Restitution Fund
Investigators  ICMJE
Principal Investigator: Catherine Marshall, M.D. Johns Hopkins University
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP