Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790213
Status:
SUSPENDED
Last Update Posted:
2024-05-20
First Post:
2023-02-07
Brief Title:
Focal Prostate Ablation With Androgen Deprivation and Novel Hormonal Therapy for Intermediate Risk Prostate Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Phase II Trial of Combination of Focal Prostate Ablation With Androgen Deprivation and Novel Hormonal Therapy for the Treatment of Intermediate Risk Prostate Cancer
Status:
SUSPENDED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Temporary Accrual Hold as Principal PI Moves Institutions and seeks additional funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the proportion of men with residualrecurrent clinically significant prostate cancer Grade Group 2 disease in the ablated or unablated prostate tissue following the combination treatment of 6-months of androgen deprivation therapy apalutamide and partial ablation of the prostate in men with newly diagnosed non-metastatic intermediate risk prostate cancer specifically men with a histopathologic diagnosis of Grade Group 2 3 with prostate specific antigen level 20 ngmL
And to assess the safety of the combination treatment of androgen deprivation therapy apalutamide and partial ablation of the prostate for the management of these patients
And to assess the safety of the combination treatment of androgen deprivation therapy apalutamide and partial ablation of the prostate for the management of these patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None