Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05011383
Status:
RECRUITING
Last Update Posted:
2023-08-18
First Post:
2021-08-11
Brief Title:
High Dose Testosterone for ATM CDK12 or CHEK2 Altered Prostate Cancers
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency
Status:
RECRUITING
Status Verified Date:
2024-08
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:
VA-BAT
Brief Summary:
This study will determine whether the presence of DNA repair deficiency in the form of alterations in the genes ATM CDK12 or CHEK2 predicts for a high likelihood of responding to the use of intermittent high dose testosterone This therapy may result in responses in tumors which are genetically unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis
Detailed Description:
This is an unblinded three cohort phase II study evaluating the efficacy of high dose testosterone BAT for patients with mCRPC and inactivating mutations in ATM CDK12 or CHEK2 Patients will receive BAT until disease progression or intolerance whichever occurs first Throughout the study safety and tolerability will be assessed by frequent recording of adverse events vital signs and safety laboratory assessments Progression will be evaluated with bone scan CT of the abdomenpelvis and PSA as per PCWG3 criteria
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