Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397703
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-29
Brief Title:
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy And Ultra-Hypofractionated SBRT Versus Ultra-Hypofractionated SBRT Alone For Unfavorable Intermediate Risk Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For this proposed Phase III study unfavorable intermediate risk prostate cancer patients will be randomized to receive 6 months of Androgen Deprivation Therapy ADT in conjunction with stereotactic body radiation therapyradiosurgery SBRT directed to the prostate versus SBRT alone The patient population will include those with National Comprehensive Cancer Network NCCN-defined unfavorable intermediate risk disease All patients will be followed every 6 months for up to 5 years from the first patient randomized and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control
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?:
False
Is an FDA AA801 Violation?:
None