NCT04331717

Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-16
• Primary completion: 2023-08-01
• Completion: 2023-12-01
• First posted: 2020-04-02
• Last updated: 2022-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study