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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
These patients will undergo embolization with 300-500µm Bead Block particles.
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.
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
Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
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.
Time frame: At 6 months
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.
Time frame: Up to 6 months
Change in Blood Pressure
Blood pressure (mmHg) will be assessed for changes over the specified time points.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48
Change in Respiratory Rate
Respiratory rate in breaths per minute will be assessed for changes over the specified time points.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48
Change in Oxygen saturation
Oxygen saturation (percentage) will be assessed for changes over the specified time points.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48
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