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Hormone Therapy

Olaparib + Abiraterone for Prostate Cancer

Phase 3

Waitlist Available

Led By Fred Saad, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Provision of informed consent for genetic research prior to collection of sample

Provision of informed consent for biomarker research prior to collection of sample

Must not have

Active infection or other medical condition that would make prednisone/prednisolone use contraindicated

Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed from date of randomisation to data cut off (dco1): 30jul2021 (approx. 2 years 9 months)

Awards & highlights

Pivotal Trial

Summary

This trial is testing the combination of olaparib and abiraterone versus placebo and abiraterone to see if it is more effective and has fewer side effects in patients with mCRPC who have not received prior chemotherapy or NHAs.

Who is the study for?

Men over 18 with metastatic castration-resistant prostate cancer who haven't had chemotherapy or new hormonal agents for this stage of cancer. They must be on androgen deprivation therapy, have normal organ and bone marrow function, an ECOG status of 0-1, a life expectancy of at least 6 months, and agree to use contraception. Those with other active cancers, heart issues, uncontrolled conditions or infections are excluded.

What is being tested?

The trial is testing the effectiveness and safety of combining olaparib with abiraterone versus placebo plus abiraterone in men with mCRPC. It aims to see if this combination can help control the cancer better without causing severe side effects.

What are the potential side effects?

Possible side effects include fatigue, nausea, digestive issues like diarrhea or constipation, blood-related problems such as anemia or clotting disorders; there may also be risks related to liver health and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have given my consent for genetic research.

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I have given my consent for biomarker research.

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My prostate cancer was confirmed through a tissue test.

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I am on hormone therapy for cancer and my testosterone levels are low.

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My scans show at least one cancer spread to another part.

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I will use a condom during and for 3 months after treatment when with a partner who can get pregnant.

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My prostate cancer is advanced and not responding to hormone therapy.

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My condition is worsening and I am a candidate for abiraterone therapy.

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My physical health has been stable or better for the last 2 weeks.

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I am at least 18 years old, or 19 if I'm from South Korea.

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I have a suitable tissue sample for testing my cancer's response to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any conditions that prevent me from taking prednisone.

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I am scheduled for heart surgery or a procedure to open my heart's arteries.

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I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.

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I cannot take pills by mouth or have stomach issues that affect medication absorption.

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I may have brain metastases but haven't been tested for it.

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I am allergic to olaparib, abiraterone, or similar drugs.

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I take more than 10mg of corticosteroids daily for a chronic condition.

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I have another cancer that has worsened or needed treatment in the last 5 years.

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I have never been treated with PARP inhibitors like olaparib.

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I have been treated with medication that affects hormone production.

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I have had surgery to improve blood flow in my heart, neck, or limbs.

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I have no lasting side effects from past cancer treatments, except for hair loss.

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My heart is not pumping well, with an ejection fraction less than 50%.

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I have been diagnosed with MDS/AML or show signs of these conditions.

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I have an active hepatitis B or C infection.

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I have uncontrolled hormone gland problems.

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My immune system is weak.

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I am not currently using strong or moderate drugs that affect liver enzymes.

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I am not currently using any strong or moderate drugs that affect liver enzymes.

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I have had a bone marrow or double cord blood transplant.

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I have not had major surgery in the last 2 weeks or have fully recovered from one.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed from date of randomisation to data cut off (dco1): 30jul2021 (approx. 2 years 9 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed from date of randomisation to data cut off (dco1): 30jul2021 (approx. 2 years 9 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from date of randomisation to data cut off (dco1): 30jul2021 (approx. 2 years 9 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment

Secondary study objectives

Brief Pain Inventory-Short Form (BPI-SF)

Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)

Number of Participants With First Symptomatic Skeletal Related Event (SSRE)

+5 more

Side effects data

From 2023 Phase 3 trial • 387 Patients • NCT02987543

43%

Anaemia

43%

Nausea

30%

Decreased appetite

27%

Fatigue

21%

Diarrhoea

19%

Constipation

19%

Vomiting

14%

Asthenia

14%

Back pain

13%

Oedema peripheral

11%

Cough

10%

Arthralgia

Dyspnoea

Dyspepsia

Weight decreased

Dysgeusia

Thrombocytopenia

Musculoskeletal pain

Dizziness

Urinary tract infection

Headache

Pyrexia

Neutropenia

Musculoskeletal chest pain

Lymphopenia

Insomnia

Stomatitis

Pain in extremity

Pneumonia

Haematuria

Pulmonary embolism

Sepsis

Femur fracture

Hyponatraemia

Muscular weakness

Pneumonia aspiration

Pneumothorax

Cardiopulmonary failure

Urinary retention

Bone pain

Cerebrovascular accident

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A+B Olaparib 300mg bd

Cohort A+B Investigators Choice of NHA

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: olaparib plus abirateroneExperimental Treatment2 Interventions

Olaparib is available as a film-coated tablet containing 100 milligrams (mg) or 150 milligrams (mg) of olaparib. Subjects will be administered olaparib orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.

Group II: placebo plus abirateronePlacebo Group1 Intervention

Placebo to match olaparib is available as a film-coated tablet in 100 milligrams (mg) or 150 milligrams (mg). Subjects will be administered placebo orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

olaparib

2009

Completed Phase 3

~990

abiraterone acetate

2017

Completed Phase 4

~920