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

Obesity, Morbid Clinical Trial

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

Status Withdrawn

Clinical 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. 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Obesity, Morbid
• Prostate Adenocarcinoma

• NCT number: NCT04331717
• Study type: Interventional
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 16, 2020
• Completion date: December 2023