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Hormone Therapy

Arm II (enzalutamide) for Prostate Cancer

Phase 4
Waitlist Available
Led By Alicia Morgans, M.D., M.P.H.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, 3 months, 6 months, and 12 months
Awards & highlights

Study Summary

This trial looks at whether prostate cancer treatment affects brain function and structure, and whether certain genetic variations make patients more or less sensitive to these changes.

Eligible Conditions
  • Hormone-Refractory Prostate Cancer
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, 3 months, 6 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, 3 months, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive function defined by overall Cogstate score and Cogstate module scores for each domain
Secondary outcome measures
Depression by Patient Health Questionnaire (PHQ-9)
Fatigue assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT- Fatigue)
Instrumental activities of daily living by Texas Functional Living Scale
+2 more
Other outcome measures
Imaging assessed by MRI
SNPs associated with cognitive function

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (enzalutamide)Experimental Treatment2 Interventions
Patients receive standard of care treatment with GnRH agonist/antagonist therapy. Patients also receive enzalutamide PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo cognitive assessment and MRI program as in Arm I.
Group II: Arm I (abiraterone acetate, prednisone)Experimental Treatment3 Interventions
Patients receive standard of care treatment with GnRH agonist/antagonist therapy. Patients also receive abiraterone acetate PO and prednisone PO BID in the absence of disease progression or unacceptable toxicity. Patients then undergo cognitive assessment comprising of neuro-cognitive tests and assessments of overall quality of life, fatigue, pain, and symptoms at baseline, 3, 6, and 12 months. Patients also undergo MRI program for 40 minutes comprising of DTI, fMRI, ASL MRI, MPRAGE MRI, FLAIR MRI, and BOLD MRI at baseline and 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Enzalutamide
FDA approved
Abiraterone
FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,564 Total Patients Enrolled
20 Trials studying Prostate Cancer
2,959 Patients Enrolled for Prostate Cancer
Alicia Morgans, M.D., M.P.H.Principal InvestigatorNorthwestern University
~12 spots leftby Jun 2025
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