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Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer

NCT03016741 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-24

No results posted yet for this study

Summary

This clinical trial studies cognitive function in men with prostate cancer treated with androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes in brain structure or activity related to treatment that may be related to changes in cognitive function. The investigators are also looking for genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer.

Conditions

  • Castration-Resistant Prostatic Cancer
  • Metastatic Prostate Carcinoma
  • Recurrent Prostate Carcinoma
  • Stage IV Prostate Cancer
  • Hormone-Refractory Prostate Cancer

Interventions

BIOLOGICAL

GnRH agonist/antagonist

Given GnRH agonist/antagonist therapy

DRUG

Prednisone

Given by mouth

DRUG

Abiraterone Acetate

Given by mouth

DRUG

Enzalutamide

Given by mouth

Sponsors & Collaborators

Principal Investigators

  • David VanderWeele, M.D., M.P.H. · Northwestern University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2023-01-04
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03016741 on ClinicalTrials.gov