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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, 3 months, 6 months, and 12 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,131 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any extensive locations across the US that are currently running this research?

"Conducted at 4 sites, this research is occurring in Nashville, Minneapolis and Los Angeles with an additional 4 locations. For participants' convenience it's recommended to pick the closest clinic for attendance."

Answered by AI

What medical conditions have been known to improve with this particular therapy?

"Thyroiditis is regularly managed by this treatment, and it can also be beneficial in treating ulcerative colitis, cancerous tumours, and the varicella-zoster virus' acute retinal necrosis."

Answered by AI

Are there still openings to join this medical venture?

"According to the clinicaltrials.gov database, this trial is actively recruiting for participants. Initially made available on March 31st 2017 and updated as recently as April 30th 2021, the study seeks suitable candidates to join."

Answered by AI

Has this treatment attained the sanction of the Food and Drug Administration?

"The treatment has already been approved, so it earned a score of 3 in terms of safety."

Answered by AI

How many individuals are currently being administered the treatment in this clinical trial?

"To achieve this trial's goals, 100 qualified participants are needed. Vanderbilt-Ingram Cancer Center in Nashville and University of Minnesota: Masonic Cancer Center in Minneapolis serve as two potential locations for recruitment."

Answered by AI

Could you provide information on the other research that has been conducted regarding this particular therapy?

"The Providence Cancer Center at the Providence Portland Medical Center was where this intervention first underwent testing in 2001. Subsequently, 812 trials were concluded while 476 investigations are still ongoing; notably a great many of these experiments are taking place in Nashville, Tennessee."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer

2017. "Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03016741.

All > Advanced Prostate Cancer > Abiraterone Acetate