Loading clinical trials...

Real-World Study of Enzalutamide and Abiraterone Acetate (With Prednisone) Tolerability | Clinical Trials | Clareo Health

COMPLETED

Real-World Study of Enzalutamide and Abiraterone Acetate (With Prednisone) Tolerability

A Multicenter, Two-arm, Prospective, Observational Study to Characterize the Tolerability of Treatment With Enzalutamide or Abiraterone Acetate (With Prednisone) for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT02663193•Janssen Scientific Affairs, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to characterize the tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS) tolerability-and quality of life (QoL) after approximately 2 months of participants starting treatment with one of these agents for metastatic castration-resistant prostate cancer (mCRPC).

Detailed Description

This is a multicenter (more than one study site), open-label (all people know the identity of the intervention), prospective, observational study to characterize the tolerability profile of treatment and quality of life (QoL) in participants receiving enzalutamide or abiraterone acetate (with prednisone) in a clinical practice setting. Approximately 100 male participants will be enrolled into this study, 50 participants will be recruited to each treatment arm. Participants will complete 2 scheduled on-site visits (Baseline and Month 2). Participants will primarily be observed for tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) and safety over an observational period of 2 months.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Male 18 years of age or older
•Have confirmed metastatic adenocarcinoma of the prostate
•Are starting treatment with enzalutamide or abiraterone acetate (with prednisone) for metastatic castration-resistant prostate cancer (mCRPC) at the full recommended dose per each drug's respective prescribing information (PI)
•Have an Eastern Cooperative Oncology Group Performance Status score of 0 or 1
•Sign written informed consent

Exclusion Criteria

•Have a pre-existing central nervous system (CNS) condition (including, but not limited to, history of stroke or dementia) that, in the participating physician's judgment, would preclude participation in the study
•Have known mental illness including, but not limited to, major depressive disorder, general anxiety disorder, or bipolar disorder that, in the participating physician's opinion, could significantly confound the patient-reported outcome (PRO) assessments
•Have a history of or ongoing seizure disorder
•Have severe hepatic impairment (Child-Pugh Class C)
•Have an active infection (example, human immunodeficiency virus \[HIV\], viral hepatitis) or other medical condition that would contraindicate the use of prednisone/prednisolone (systemic glucocorticoid)
•Have known alcohol or other substance abuse disorder
•Are routinely taking medication-including, but not limited to, over-the-counter medications, supplements, medical marijuana or prescription pain medication-that is known to cause mental confusion or sedation or are using any of the medications
•Are routinely taking systemic glucocorticoids (example, prednisone, prednisolone, dexamethasone) at a dosage higher than the equivalent of prednisone 10 milligram (mg) daily
•Are currently using or have previously used chemotherapy for any cancer including mCRPC
•Are concurrently using any first-generation androgen-receptor blocker (example, bicalutamide, flutamide, nilutamide) for mCRPC
+2 more criteria

Locations (20)

Homewood, Alabama, United States

La Mesa, California, United States

Wheat Ridge, Colorado, United States

Daytona Beach, Florida, United States

Indianapolis, Indiana, United States

Jeffersonville, Indiana, United States

Saint Clair Shores, Michigan, United States

Englewood, New Jersey, United States

Lawrenceville, New Jersey, United States

Morristown, New Jersey, United States

Key Dates

Start Date

December 1, 2015

Primary Completion Date

January 1, 2017

Completion Date

January 1, 2017

Last Updated

February 3, 2025

Enrollment

108

ACTUAL participants

Conditions

Prostate Cancer

Interventions

No Intervention

OTHER

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Real-World Study of Enzalutamide and Abiraterone Acetate (With Prednisone) Tolerability

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC