Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06212583
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-12-14
Brief Title:
High-Risk Metachronous Oligometastatic Prostate Cancer Trial
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Randomized Trial of High-risK metachroNous oligometastatIc Prostate Cancer With hiGh-risk Mutations Treated witH meTastasiS Directed Therapy and NiraparibAbiraterone Acetate and Prednisone KNIGHTS
Status:
RECRUITING
Status Verified Date:
2024-04
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:
KNIGHTS
Brief Summary:
The purpose of this research study is to compare the effects good andor bad of using the standard of care treatment hormonal therapy Stereotactic Ablative Radiation SABR to the metastatic lesions compared to standard of care and addition of 6-months of niraparibabiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer
Detailed Description:
In this trial all participants will be randomized to one of the two groups You will be randomly assigned by chance like the flip of a coin to one of the two groups 1 Standard of care treatment hormonal therapy SABR to the metastatic lesions or 2 Standard of care treatment 6-months of niraparibabiraterone acetate combination pills and prednisone Participants in both groups will receive rectal swabs and various blood tests to assess circulating tumor cells genomic sequencing and tumor markers Both groups will also participate in quality-of-life surveys
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCC 23100 | OTHER | University of Maryland Medical System | None |