Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627530
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Trial of Neoadjuvant Leuprorelin Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COAction
Brief Summary:
A Randomized Trial of Neoadjuvant Leuprorelin Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer Prospective randomized parallel group open-label with blinded endpoint adjudication multicenter clinical trialTo assess among patients with unfavorable intermediate to high-risk prostate cancer whether a neoadjuvant combined treatment with leuprorelin Leuprorelin and darolutamide is superior to monotherapy in terms of complete or almost complete pathological responseA total of 144 patients with unfavorable intermediate to high-risk prostate cancer scheduled for radical prostatectomy with extended pelvic lymph node dissection will be randomized 111 to oral darolutamide SC leuprorelin Leuprorelin or both 48 patients per arm for 24 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None