Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-02-08 @ 12:38 PM
Study NCT ID:
NCT03173859
Status:
WITHDRAWN
Last Update Posted:
2020-11-18
First Post:
2017-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients
Sponsor:
University of Athens
Organization:
Study Overview
Official Title:
A Randomized Phase II Study to Investigate the Efficacy of Rotations Between Abiraterone Acetate and Apalutamide Versus Sequential Administration in Chemo-naïve Metastatic Castration Resistant Prostate Cancer Patients
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Delayed initiation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AERA
Brief Summary:
A randomized phase II study comparing the sequential use of abiraterone followed after progression by apalutamide with alternating cycles of abiraterone and apalutamide
Detailed Description:
This is an open-label, randomized phase II study to investigate the feasibility of alternating cycles of treatment with abiraterone plus prednisone and apalutamide compared to sequential treatment of abiratereone plus prednisone followed by apalutamide. 7 centers in Greece will participate in the study.
The study population consists of adult patients (over 18 years old) with histologically confirmed metastatic prostate adenocarcinoma who have disease progression - as defined by PCWG2 criteria - despite androgen deprivation therapy and who have not received prior therapy for their castration resistant disease.
The purpose of the study is to determine the progression free survival, feasibility and safety profile of the experimental arm compared to standard of care.
In the experimental arm alternating treatment will consist of repeating cycles of 24 weeks of treatment consisting of 12 weeks of abiraterone acetate 1000mg orally qd and prednisone 5mg orally bid, followed by 12 weeks of apalutamide 240 mg per day. There will be no wash out period between cycles.
The comparative arm will be the standard regimen of abiraterone 1000mg orally qd plus prednisone 5mg orally bid until progression, followed thereafter by apalutamide 240mg orally qd until progression.
The study population consists of adult patients (over 18 years old) with histologically confirmed metastatic prostate adenocarcinoma who have disease progression - as defined by PCWG2 criteria - despite androgen deprivation therapy and who have not received prior therapy for their castration resistant disease.
The purpose of the study is to determine the progression free survival, feasibility and safety profile of the experimental arm compared to standard of care.
In the experimental arm alternating treatment will consist of repeating cycles of 24 weeks of treatment consisting of 12 weeks of abiraterone acetate 1000mg orally qd and prednisone 5mg orally bid, followed by 12 weeks of apalutamide 240 mg per day. There will be no wash out period between cycles.
The comparative arm will be the standard regimen of abiraterone 1000mg orally qd plus prednisone 5mg orally bid until progression, followed thereafter by apalutamide 240mg orally qd until progression.
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-000443-41 | EUDRACT_NUMBER | None | View |