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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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

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My prostate cancer was confirmed through a tissue examination.

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I am fully active or can carry out light work.

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I have had surgery to remove my prostate.

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I am 18 years old or older.

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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:

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

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

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I have been treated with specific prostate cancer medications before.

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I have had both testicles surgically removed.

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

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

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My high blood pressure is not under control.

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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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Metastasis-Free Survival

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

Overall Survival

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~5750

Abiraterone Acetate

2015