Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06193993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-12-05
Brief Title:
Effect of Low-dose 500 mg Abiraterone Acetate in Treatment of Metastatic Prostate Cancer Patients
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Low-dose 500 mg Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer mCRPC and Metastatic Hormone-sensitive Prostate Cancer mHSPC Patients a Phase I Proof-of-concept Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
This will be an open label Phase I study to assess the efficacy of a reduced 500 mg dose of abiraterone acetate in patients with metastatic prostate cancer Eligible metastatic hormone-sensitive prostate cancer mHSPC and metastatic castration-resistant prostate cancer mCRPC patients newly initiated on abiraterone acetate treatment will be recruited to receive a reduced 500 mg dose of abiraterone acetate plus prednisolone The study treatment duration will span 12 weeks after which patients being administered the reduced dose will be reverted to the standard 1000 mg dosing Follow-up for mCRPC and mHSPC patients will last for 18 and 36 months respectively The main question the study aims to answer is whether dose reduction of abiraterone acetate to 500 mg would achieve antitumor activity in mCRPC and mHPSC patients comparable to standard of care
Detailed Description:
Primary Objectives
As a preliminary Phase I trial the primary objective of the study would be to evaluate the percentage change in prostate specific antigen PSA from baseline to 12 weeks
Secondary Objectives
1 determine the proportion of patients achieving PSA response 50 reduction in PSA after 12 weeks of therapy
2 evaluate the pharmacokinetics associated with the 500 mg dose of abiraterone acetate
3 investigate the correlation between plasma exposure of abiraterone and CP-I or CP-III in order to support their utility as a biomarker of OATP1B11B3 function
4 assess the pharmacodynamic effects of the reduced 500 mg dose on the maximal percentage change in serum androgens dehydroepiandrosterone DHEA dehydroepiandrosterone-sulfate DHEA-S testosterone androstenedione from baseline
As a preliminary Phase I trial the primary objective of the study would be to evaluate the percentage change in prostate specific antigen PSA from baseline to 12 weeks
Secondary Objectives
1 determine the proportion of patients achieving PSA response 50 reduction in PSA after 12 weeks of therapy
2 evaluate the pharmacokinetics associated with the 500 mg dose of abiraterone acetate
3 investigate the correlation between plasma exposure of abiraterone and CP-I or CP-III in order to support their utility as a biomarker of OATP1B11B3 function
4 assess the pharmacodynamic effects of the reduced 500 mg dose on the maximal percentage change in serum androgens dehydroepiandrosterone DHEA dehydroepiandrosterone-sulfate DHEA-S testosterone androstenedione from baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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