Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03173859

Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients — AERA  

Prostatic Neoplasms, Castration-Resistant Clinical Trial

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

Clinical Trial Summary

A randomized phase II study comparing the sequential use of abiraterone followed after progression by apalutamide with alternating cycles of abiraterone and apalutamide

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03173859
Study type Interventional
Source University of Athens
Contact
Status Withdrawn
Phase Phase 2
Start date January 2018
Completion date December 31, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04104776 - A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas Phase 1/Phase 2
Withdrawn NCT03325127 - Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study
Withdrawn NCT02906605 - A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer Phase 2
Recruiting NCT05743621 - Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer Phase 1
Completed NCT02204072 - BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC) Phase 1
Recruiting NCT05393791 - Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC Phase 2
Active, not recruiting NCT03927391 - Effect of a Reduced Dose Enzalutamide in Frail (m)CRPC Patients on Cognitive Side Effects Phase 4
Completed NCT02450812 - Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany
Not yet recruiting NCT06353386 - Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) Phase 1/Phase 2
Active, not recruiting NCT03431350 - A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer Phase 1/Phase 2
Active, not recruiting NCT03822845 - Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer Phase 2/Phase 3
Completed NCT02162836 - A Safety Study of JNJ-56021927 in Participants With Metastatic Castration-Resistant Prostate Cancer Phase 1
Completed NCT02899104 - Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
Active, not recruiting NCT04381832 - Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer Phase 1/Phase 2
Completed NCT03563014 - A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223
Active, not recruiting NCT05968599 - A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
Active, not recruiting NCT02803437 - Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
Recruiting NCT05944237 - HTL0039732 in Participants With Advanced Solid Tumours Phase 1/Phase 2
Terminated NCT02057666 - Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer Phase 3
Active, not recruiting NCT04717154 - Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer Phase 2