← Back to Search

Hormone Therapy

Apalutamide + Abiraterone Acetate for Prostate Cancer

Phase 3

Waitlist Available

Led By Monica Bertagnolli, MD

Research Sponsored by Alliance Foundation Trials, LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed prostate adenocarcinoma

Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1

Must not have

Gastrointestinal disorder affecting absorption or the ability to swallow tablets

Prior androgen deprivation therapy and/or first generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior ADT and/or first generation anti-androgen in the (neo)adjuvant and/or salvage setting before, during, and/or following radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is > 9 months prior to date of randomization and total duration of prior therapy is ≤ 36 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

Summary

This trial is testing whether two different drugs can extend the time before cancer progresses in men with recurrent prostate cancer.

Who is the study for?

Men with high-risk, biochemically recurrent prostate cancer and a PSA doubling time of ≤9 months. They must have had prior surgery or radiation, no metastases on scans, an ECOG status of 0-1 (fully active to restricted in physically strenuous activity), and agree to contraception use. Exclusions include previous chemotherapy for prostate cancer (except as neoadjuvant/adjuvant therapy), recent use of certain medications, uncontrolled hypertension, severe liver impairment, and conditions predisposing to seizures.Check my eligibility

What is being tested?

This phase 3 trial is testing the effectiveness of three different treatment combinations: Apalutamide with LHRH Analogue; Abiraterone Acetate with Prednisone; or both combinations together in men whose prostate cancer has returned but without visible metastasis. Participants are randomly assigned to one of these three groups.See study design

What are the potential side effects?

Possible side effects include fatigue, hot flashes, joint pain from Apalutamide; hormonal changes from LHRH Analogues; increased blood pressure and mineral imbalances from Abiraterone Acetate; weight gain and mood swings from Prednisone. Each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer was confirmed through a tissue examination.

Select...

I am fully active or can carry out light work.

Select...

I have had surgery to remove my prostate.

Select...

I am 18 years old or older.

Select...

My prostate cancer has returned, and my PSA levels are doubling in 9 months or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a stomach or intestine condition that affects how I absorb medicine or swallow pills.

Select...

I've had hormone therapy for prostate cancer but stopped it more than 9 months ago.

Select...

I have been treated with specific prostate cancer medications before.

Select...

I have had both testicles surgically removed.

Select...

My liver is not working well (Child-Pugh B or C).

Select...

I take more than 5 mg of prednisone or its equivalent daily for a chronic condition.

Select...

My high blood pressure is not under control.

Select...

I have a condition or history that increases my risk of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PSA progression-free survival in the intent-to-treat population

Secondary outcome measures

Metastasis-Free Survival

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Overall Survival

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C: Degarelix/Apalutamide/Abiraterone/PrednisoneExperimental Treatment4 Interventions

Patients will receive apalutamide and abiraterone acetate, in addition to either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.

Group II: Arm B: Degarelix/ApalutamideExperimental Treatment2 Interventions

Patients will receive apalutamide and either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.

Group III: Arm A: Degarelix Monotherapy OR Leuprolide/BicalutamideActive Control1 Intervention

Patients will receive degarelix OR leuprolide with bicalutamide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apalutamide

2015

Completed Phase 2

~3310

Abiraterone Acetate

2015

Completed Phase 4

~1880

Prednisone

2014

Completed Phase 4

~2370

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance Foundation Trials, LLC.Lead Sponsor

23 Previous Clinical Trials

24,528 Total Patients Enrolled

2 Trials studying Prostate Cancer

11,446 Patients Enrolled for Prostate Cancer

Janssen Research & Development, LLCIndustry Sponsor

980 Previous Clinical Trials

6,383,789 Total Patients Enrolled

7 Trials studying Prostate Cancer

1,674 Patients Enrolled for Prostate Cancer

Monica Bertagnolli, MDPrincipal InvestigatorAlliance Foundation Trials, LLC.

11 Previous Clinical Trials

8,328 Total Patients Enrolled

1 Trials studying Prostate Cancer

132 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03009981 — Phase 3

Prostate Cancer Research Study Groups: Arm A: Degarelix Monotherapy OR Leuprolide/Bicalutamide, Arm B: Degarelix/Apalutamide, Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone

Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT03009981 — Phase 3

Abiraterone Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03009981 — Phase 3

~60 spots leftby Jul 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.