Androgen Receptor Therapies for Prostate Cancer

Recruiting at 4 trial locations

Overseen By Study Coordinator

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Northwestern University

Must be taking: GnRH agonists, GnRH antagonists

Must not be taking: Psychotropic medications, Illicit drugs

Disqualifiers: Cognitive impairment, Seizure history, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David VanderWeele, M.D., M.P.H.

Principal Investigator

Northwestern University

Eligibility Criteria

Men with advanced prostate cancer who can take oral meds, complete English surveys without help, and have either newly diagnosed metastatic hormone sensitive or castration-resistant prostate cancer. They must be willing to sign consent in English, may have had certain prior treatments but not extensive chemotherapy or brain radiation, and should be over 18 years old.

Inclusion Criteria

Patients must be able to take oral medication

Willing and able to complete survey questionnaires in English without assistance through the duration of the study. This stipulation is in place because not all of the proposed quality of life or cognitive tests are available or validated in other languages

Have either newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC) or castration-resistant metastatic prostate cancer (mCRPC) and eligible to undergo treatment with abiraterone acetate (mHSPC or mCRPC) or enzalutamide (mCRPC)

Exclusion Criteria

Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations/substance abuse that would limit compliance with study requirements

Patients with a 'currently active' second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a 'currently active' malignancy if they have completed all therapy and are now considered without evidence of disease for 1 year. Patients with cognitive dysfunction related to treatment of another malignancy, including a history of 'chemo-brain', are ineligible

Patients taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior. Appropriate treatment by a licensed provider with medications for depression or anxiety, including but not limited to SSRIs, SNRIs, and standard dose benzodiazepines at a stable dose, is permitted

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive androgen receptor directed therapies such as abiraterone acetate and enzalutamide, with cognitive assessments and MRI imaging at baseline, 3, 6, and 12 months

12 months

4 visits (in-person) at baseline, 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abiraterone Acetate
• Enzalutamide
• GnRH agonist/antagonist
• Prednisone

Trial Overview The trial is studying the impact of androgen receptor directed therapies like abiraterone acetate and enzalutamide on cognitive function using MRI scans. It also looks for genetic factors that might influence sensitivity to cognitive changes during treatment.

Participant Groups

Group I: Arm II (enzalutamide) Experimental Treatment 2 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 Treatment 3 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.

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic high-risk castration-sensitive prostate cancer

Approved in European Union as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic castration-sensitive prostate cancer

Approved in Japan as Zytiga for:

• Prostate cancer

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+