Abiraterone + Prednisone/Olaparib for Prostate Cancer

Recruiting at17 trial locations

Overseen by Maha Hussain, MD, FACP, FASCO

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.

Research Team

Maha Hussain, MD, FACP, FASCO

Principal Investigator

Northwestern University

Eligibility Criteria

Men with metastatic castration-resistant prostate cancer and specific DNA repair defects (like ATM, BRCA mutations) can join. They must have a life expectancy of at least 6 months, be able to take oral meds, agree to use contraception for 3+ months after the trial, and not have had certain treatments like CYP17 inhibitors or chemotherapy for resistant disease. No major surgery or uncontrolled medical issues within 14 days before joining.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

I agree to a biopsy to check for DNA repair defects in my cancer.

I agree to use contraception during and for 3 months after the study.

Exclusion Criteria

I have stopped taking all strong medications that affect liver enzymes.

I am allergic to medications similar to olaparib or abiraterone.

Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or of long QT syndrome.

Treatment Details

Interventions

• Abiraterone Acetate (Androgen Biosynthesis Inhibitor)
• Olaparib (PARP Inhibitor)
• Prednisone (Corticosteroid)

Trial Overview The study is testing three approaches: Abiraterone/Prednisone alone, Olaparib alone, or both combined in men with advanced prostate cancer who have genetic changes affecting DNA repair. It's an open-label phase II trial where patients are randomly assigned to one of the treatment arms.

Participant Groups

Group I: Arm I: Abiraterone + Prednisone Active Control 2 Interventions

Abiraterone 1000 mg orally once daily and prednisone 5 mg orally twice daily, days 1-28 in 28 day cycles.

Group II: Arm II: Olaparib Active Control 1 Intervention

Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.

Group III: Arm III: Abiraterone + Prednisone + Olaparib Active Control 3 Interventions

Abiraterone 1000 mg orally once daily, prednisone 5 mg orally twice daily, olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.

Group IV: Olaparib Active Control 1 Intervention

Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.

Abiraterone Acetate is already approved in Canada, Japan for the following indications:

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?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School