NCT02663193

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 21, 2016

Last Update Submit

January 31, 2025

Conditions

Prostate Cancer

Keywords

Prostate CancerObservational studyEnzalutamideAbiraterone AcetatePrednisoneTolerability

Outcome Measures

Primary Outcomes (6)

  • Change From Baseline in Cogstate Tests at Month 2

    The Cogstate computerized cognitive test battery will be used as the assessment tool in this study. Overall, Cogstate measures a range of cognitive functions (example, psychomotor and memory function) using a number of different tests (example, choice reaction time, one-back memory). This battery of tests was chosen because it has been shown to be sensitive to very small cognitive changes and has been tested in cancer participants after chemotherapy.

    Baseline and Month 2

  • Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 at Month 2

    The EORTC QLQ-C30 is a questionnaire developed to assess the quality of Life (QoL) of cancer participants. The QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and QoL scale.

    Baseline and Month 2

  • Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue subscale (FACIT-Fatigue) at Month 2

    The FACIT Measurement System is a collection of health-related QoL questionnaires targeted to the management of chronic illness. The fatigue subscale (FACIT-Fatigue) is a validated, 13-item questionnaire that assesses fatigue in people being treated for a chronic illness.

    Baseline and Month 2

  • Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at Month 2

    The FACT-Cog is a validated, 37-item, subjective neuropsychological instrument designed to evaluate cancer participants perceived cognitive deterioration on their quality of life.

    Baseline and Month 2

  • Participant or Caregiver Observational Questionnaire (Survey)

    If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL.

    Baseline

  • Participant or Caregiver Observational Questionnaire (Survey)

    If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL.

    Month 2

Secondary Outcomes (1)

  • Number of Participants with Adverse Events (AEs) and Serious AEs

    Screening up to follow-up (Approximately 2 Months)

Study Arms (2)

Enzalutamide Group

Participants who are receiving enzalutamide in a clinical practice setting will be observed for tolerability and quality of life.

Other: No Intervention

Abiraterone Acetate plus Prednisone group

Participants who are receiving abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life.

Other: No Intervention

Interventions

No InterventionOTHER

Participants who are receiving enzalutamide or abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life.

Abiraterone Acetate plus Prednisone groupEnzalutamide Group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who have a confirmed metastatic adenocarcinoma of the prostate will receive either enzalutamide or abiraterone acetate with prednisone for the treatment at the discretion of their treatment physician and in accordance with clinical practice.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Have previously taken enzalutamide or abiraterone acetate with prednisone
  • Are not capable of completing tests using a computerized system or completing a participant survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Homewood, Alabama, United States

Location

Unknown Facility

La Mesa, California, United States

Location

Unknown Facility

Wheat Ridge, Colorado, United States

Location

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Jeffersonville, Indiana, United States

Location

Unknown Facility

Saint Clair Shores, Michigan, United States

Location

Unknown Facility

Englewood, New Jersey, United States

Location

Unknown Facility

Lawrenceville, New Jersey, United States

Location

Unknown Facility

Morristown, New Jersey, United States

Location

Unknown Facility

Poughkeepsie, New York, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Middleburg Heights, Ohio, United States

Location

Unknown Facility

Springfield, Oregon, United States

Location

Unknown Facility

Bala-Cynwyd, Pennsylvania, United States

Location

Unknown Facility

Lancaster, Pennsylvania, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Myrtle Beach, South Carolina, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Virginia Beach, Virginia, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Janssen Scientific Affairs, LLC Clinical Trial

    Janssen Scientific Affairs, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 26, 2016

Study Start

December 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

US(20)