Apalutamide + Abiraterone for Prostate Cancer

(PANTHER Trial)

Recruiting at 13 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Daniel George, MD

Must be taking: LHRH agonists or antagonists

Must not be taking: Azole antifungals, Strong CYP3A4 inducers

Disqualifiers: Infection, Hypertension, Diabetes, Seizure, 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: 16

Duration: 24 months

93 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve a PSA \< 0.1; Radiographic assessments: to estimate the rate of objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations. This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50 Caucasian) over a 24 month accrual period. The study agents will be administerd at the following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period. Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95% confidence intervals based on the binomial distribution will be computed. In addition, post therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product limit method will be used to estimate the rPFS, biochemical PFS and overall survival distributions.

Who Is on the Research Team?

Daniel J. George, MD

Principal Investigator

Duke Cancer Institute

Are You a Good Fit for This Trial?

This trial is for African American and Caucasian men with metastatic castrate-resistant prostate cancer. Participants must be over 18, have a life expectancy of at least 12 months, and be able to take oral medication. They should not have had certain previous treatments or conditions that could interfere with the study drugs or pose risks.

Inclusion Criteria

Serum potassium ≥ 3.5 mEq/L

Serum total bilirubin ≤ 1.5 x Institutional ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)

Serum albumin of ≥ 3.0 g/dl

Exclusion Criteria

I have symptoms due to an irregular heartbeat.

- Administration of an investigational therapeutic within 30 days prior to Cycle 1, Day 1

I have had chemotherapy or biological therapy for prostate cancer, but not within the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive apalutamide, abiraterone acetate, and prednisone in 4-week cycles

24 months

Visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 4 years

Imaging every 12 weeks, survival follow-up every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone Acetate
• Apalutamide
• Prednisone

Trial Overview The trial tests apalutamide, abiraterone acetate, and prednisone in treating prostate cancer. It's an open-label study where both African American and Caucasian men receive the same treatment to compare progression-free survival (PFS) rates, PSA response, radiographic assessments, safety, and tolerability.

How Is the Trial Designed?

Group I: Caucasian Experimental Treatment 3 Interventions

Group II: African American Experimental Treatment 3 Interventions

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?

Daniel George, MD

Lead Sponsor

Trials

8

Recruited

250+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University