Apalutamide + Abiraterone Acetate for Prostate Cancer

Recruiting at 68 trial locations

Overseen By Mary-Ellen Taplin, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Alliance Foundation Trials, LLC.

Must not be taking: CYP17 inhibitors, 5-alpha reductase

Disqualifiers: Androgen deprivation therapy, Seizure, Hypertension, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

504 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.

Research Team

Suzanne George, MD

Principal Investigator

Alliance Foundation Trials, LLC.

Rahul Aggarwal, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or can carry out light work.

My blood tests show normal liver, kidney, and blood health.

My scans show no clear signs of cancer spread, except for small lymph nodes or unclear bone lesions.

Exclusion Criteria

I haven't taken 5-alpha reductase inhibitors in the last 42 days.

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

I have had chemotherapy for prostate cancer only as part of initial treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients are randomized into one of three treatment arms and treated for a maximum duration of 52 weeks

52 weeks

Follow-up

Participants are monitored for PSA progression, development of metastasis, or patient withdrawal from study

Until PSA progression or other endpoints

Long-term follow-up

Patients with PSA progression will be followed long term until the development of castration resistance, first metastasis, and death

Up to 6 years

Treatment Details

Interventions

• Abiraterone Acetate
• Apalutamide
• LHRH Analogue
• Prednisone

Trial Overview 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.

Participant Groups

Group I: Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone Experimental Treatment 4 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/Apalutamide Experimental Treatment 2 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/Bicalutamide Active Control 1 Intervention

Patients will receive degarelix OR leuprolide with bicalutamide.

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?

Alliance Foundation Trials, LLC.

Lead Sponsor

Trials

25

Recruited

27,200+

Janssen Research & Development, LLC

Industry Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires