Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT04569461
Status:
WITHDRAWN
Last Update Posted:
2025-07-04
First Post:
2020-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trimodality Approach of Low Dose iOnizing Radiation With or Without Neoadjuvant Pembrolizumab and Prostatectomy for Men With Intermediate/High Risk Prostate Cancer (TALON)
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Trimodality Approach of Low Dose iOnizing Radiation With or Without Neoadjuvant Pembrolizumab and Prostatectomy for Men With Intermediate/High Risk Prostate Cancer (TALON)
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Discontinuation of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TALON
Brief Summary:
This study will enroll prostate cancer patients with an unfavorable intermediate- or high-risk diagnosis. The purpose of this study is to determine whether a regimen of pembrolizumab and low dose prostate radiation or low dose prostate radiation alone prior to a prostatectomy affects cells of the immune system and if it is a safe option for this stage of prostate cancer. Participants will be randomized 1:1 (like flipping a coin) to receive pembrolizumab, low dose prostate radiation and a prostatectomy or low dose prostate radiation and a prostatectomy. Pembrolizumab is an investigational drug that increases the ability of the immune system to kill tumor cells. Low dose radiation can alter the way tumor cells look to the immune cells. For example, the immune cells may express different proteins that make them more susceptible to immune cell killing or the structure of the tumor may be altered to allow the immune cells to infiltrate the tumor more thoroughly. The prostate tissue collected from the prostatectomy will be analyzed for differences in pathology and local immune cell infiltration, and participants will be followed for 2 years to watch for prostate specific antigen (PSA) recurrence and prostate cancer recurrence.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: