Ignite Creation Date:
2024-05-06 @ 2:29 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04331717
Status:
WITHDRAWN
Last Update Posted:
2022-05-02
First Post:
2020-03-31
Brief Title:
Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
BASH-PC Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
accrual on hold
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BASH-PC
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB00207275 | OTHER | JHM IRB | None |