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Androgen Biosynthesis Inhibitor

Abiraterone + Prednisone/Olaparib for Prostate Cancer

Phase 2
Waitlist Available
Led By Maha Hussain, MD, FACP, FASCO
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG status of 0-2 (Appendix A: Performance Status Criteria)
Serum testosterone < 50 ng/dL. Patients must continue primary ADT with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
Must not have
Patients must stop taking all strong CYP3A4 inhibitors, including clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir, prior to registration.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or abiraterone.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Approved for 30 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment for men with metastatic castration resistant prostate cancer. It is a 1:1:1 randomized open-label multicenter phase II study, which means that patients will be randomly assigned to one of three different treatment groups. The study will take place at multiple centers, and patients will be observed over the course of the trial.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include fatigue, nausea, vomiting, low blood counts that could increase infection risk; liver problems; shortness of breath; rash; joint pain; high blood pressure and other heart-related issues. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of the day.
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My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had orchiectomy.
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I stopped taking hormone therapy for cancer 4 weeks ago and my PSA levels haven't dropped.
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I have been diagnosed with prostate adenocarcinoma, not small-cell carcinoma.
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I can swallow pills without needing to break them down.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have stopped taking all strong medications that affect liver enzymes.
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I am allergic to medications similar to olaparib or abiraterone.
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I am HIV-positive and on antiretroviral therapy, which may interact with the treatment.
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I have a specific DNA repair defect and severe disease in my organs or bones needing quick treatment.
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I haven't taken itraconazole, ketoconazole, or fluconazole in the last 3 weeks.
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I do not have a history of pituitary or adrenal problems, nor do I have active hepatitis or chronic liver disease.
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I have long-term blood-related issues, including bone marrow problems.
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I have moderate to severe liver problems.
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I have not had major surgery in the last 2 weeks or have fully recovered from it.
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I have a serious health condition that is not under control.
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I have not had a blood transfusion in the last 30 days.
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I do not have active Hepatitis B or C.
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I haven't taken any forbidden medications in the last week.
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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
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I have another active cancer besides non-dangerous skin cancer or superficial bladder cancer.
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I am not planning to undergo chemotherapy, surgery, or radiation while on the trial treatment.
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I have had a bone marrow transplant from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Objective Progression Free Survival (PFS)
Secondary study objectives
Incidence of Adverse Events
Measurable disease response rate by RECIST
PSA response rate
+6 more

Awards & Highlights

Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: Arm I: Abiraterone + PrednisoneActive Control2 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: OlaparibActive Control1 Intervention
Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.
Group III: Arm III: Abiraterone + Prednisone + OlaparibActive Control3 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: OlaparibActive Control1 Intervention
Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,645 Previous Clinical Trials
958,524 Total Patients Enrolled
19 Trials studying Prostate Cancer
2,853 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,587 Total Patients Enrolled
57 Trials studying Prostate Cancer
25,483 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,881 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Androgen Biosynthesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03012321 — Phase 2
Prostate Cancer Research Study Groups: Arm I: Abiraterone + Prednisone, Arm II: Olaparib, Arm III: Abiraterone + Prednisone + Olaparib, Olaparib
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT03012321 — Phase 2
Abiraterone Acetate (Androgen Biosynthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03012321 — Phase 2
~14 spots leftby Dec 2026
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