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Prostate AdenocarcinomaPhase 2BASH-PCNCT04331717

Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer

A Phase 2 study testing Bead Block 300-500 um, Weight Management and Lupron in people with Prostate Adenocarcinoma and Obesity, Morbid, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Adenocarcinoma, Obesity, Morbid
What is being tested?
Bead Block 300-500 um, Weight Management and Lupron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
16 Nov 2020to Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: BASH-PC: Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer

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.

Being tested
Bead Block 300-500 um, Weight Management, Lupron
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bead Block 300-500 umDevice

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

  • Weight ManagementBehavioural

    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.

  • LupronDrug

    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 groups in NCT04331717
Study groupRoleWhat they receive
Diet and exercise with BAEExperimentalAfter 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).
Receives: Device: Bead Block 300-500 um; Behavioral: Weight Management; Drug: Lupron

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 6 months

Secondary outcomes (4)

  1. Number of adverse events

    Number of adverse events will be assessed to determine if there are any increased adverse events in men with prostate cancer undergoing BAE.

    Measured: Up to 6 months

  2. Change in Blood Pressure

    Blood pressure (mmHg) will be assessed for changes over the specified time points.

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

  3. Change in Respiratory Rate

    Respiratory rate in breaths per minute will be assessed for changes over the specified time points.

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

  4. Change in Oxygen saturation

    Oxygen saturation (percentage) will be assessed for changes over the specified time points.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2020
  2. Study start16 Nov 2020
  3. Primary completionAug 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Why it stopped: accrual on hold

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04331717
Sponsor's protocol ID
J1943
Other IDs
IRB00207275
Acronym
BASH-PC
Status last verified
Apr 2022
First submitted
31 Mar 2020
Last updated
2 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bead Block 300-500 um, Weight Management and Lupron in people with Prostate Adenocarcinoma and Obesity, Morbid, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who experience at least 5 percent weight loss (time frame: At 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04331717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.

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