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Hormone Therapy

Abiraterone/Enzalutamide/Apalutamide for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving or will receive androgen-deprivation therapy
Age ≥18 years of age on day of signing informed consent
Must not have
Presence of certain malignancies or conditions
History of seizure or conditions predisposing to seizure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial looked at how well two different drugs work in people with a certain kind of cancer. The drugs worked well, and the people who got them had better outcomes than people who didn't. The trial was done in a group of people who all have the same kind of cancer, and the results showed that the drugs worked well in this group.

Who is the study for?
This trial is for Veterans with advanced prostate cancer who are at least 18 years old, can consent to the study, have a good performance status (able to carry out daily activities), and haven't received certain other treatments. They should be on hormone therapy but not previously treated with abiraterone, enzalutamide, or apalutamide.
What is being tested?
The trial is testing three medications: Enzalutamide, Apalutamide, and Abiraterone acetate in veterans with castrate-sensitive prostate cancer. It aims to find which drug works best for improving survival without disease progression.
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, skin rash, nausea, decreased appetite and weight loss. There may also be risks of liver function changes and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am undergoing or will undergo hormone therapy for my cancer.
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I am 18 years old or older.
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My prostate cancer is confirmed without specific features.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a specific type of cancer or condition.
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I have a history of seizures or conditions that could lead to seizures.
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I have not taken specific medications or been in certain trials before.
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I haven't had hormonal or biologic therapy in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PSA Progression
Secondary study objectives
PSA Response

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Active Control
Group I: Abiraterone AcetateActive Control1 Intervention
Group II: Standard of CareActive Control2 Interventions

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,680 Total Patients Enrolled

Media Library

Abiraterone acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05422911 — Phase 2
Prostate Cancer Research Study Groups: Abiraterone Acetate, Standard of Care
Prostate Cancer Clinical Trial 2023: Abiraterone acetate Highlights & Side Effects. Trial Name: NCT05422911 — Phase 2
Abiraterone acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05422911 — Phase 2
~33 spots leftby Jun 2025
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