Study of Olaparib and Abiraterone for Men with Advanced Prostate Cancer Resistant to Hormone Therapy

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). This is a form of prostate cancer that has spread to other parts of the body and continues to grow even when the amount of testosterone in the body is reduced to very low levels. The study is testing a combination of two medications, olaparib and abiraterone, to see how effective they are when used together as a first treatment option for men with this type of cancer. Olaparib, also known by its code name AZD2281, is a medication that targets cancer cells by interfering with their ability to repair DNA. Abiraterone is a medication that helps to lower the levels of male hormones in the body, which can help slow the growth of prostate cancer.

The purpose of the study is to compare the effectiveness of the combination of olaparib and abiraterone against a placebo combined with abiraterone. Participants in the study will be randomly assigned to receive either the combination of olaparib and abiraterone or a placebo and abiraterone. The study will be conducted over a period of 90 days, during which participants will take the medications orally. The study aims to determine how well the combination of olaparib and abiraterone works in delaying the progression of the cancer, as well as its impact on overall survival and other health outcomes.

Throughout the study, participants will be monitored for any changes in their condition, including the time it takes for the cancer to progress, the time until the first use of pain medication, and overall survival. The study will also look at the quality of life of participants, including their physical and functional well-being. The trial is expected to provide valuable information on the potential benefits of using olaparib and abiraterone together as a treatment for men with metastatic castration-resistant prostate cancer.

1 joining the study

Upon joining the study, the participant will be required to provide signed informed consent. This includes agreeing to comply with the study’s requirements and restrictions.

The participant must have normal organ and bone marrow function, confirmed by tests conducted within 28 days before starting the study treatment.

2 initial assessment

The participant’s prostate cancer must be confirmed as metastatic and resistant to castration. This means the cancer has spread to other parts of the body and does not respond to treatments that lower testosterone.

The participant must continue ongoing androgen deprivation therapy, which reduces male hormones, throughout the study.

3 randomization and treatment

Participants will be randomly assigned to receive either the combination of olaparib and abiraterone or a placebo with abiraterone.

The treatment involves taking olaparib and abiraterone orally. Olaparib is available in 150 mg and 100 mg film-coated tablets, while abiraterone is also administered orally.

4 treatment duration

The treatment will continue until there is evidence of disease progression or unacceptable side effects occur.

Participants will be monitored regularly to assess the effectiveness of the treatment and any side effects.

5 monitoring and follow-up

Regular assessments will be conducted to monitor the participant’s health and the progression of the cancer. This includes imaging tests to check for radiological progression.

The study aims to measure various outcomes, such as overall survival and time to pain progression.

6 end of study participation

Participation in the study will conclude when the treatment is no longer effective, or the participant chooses to withdraw.

The estimated end date for the study is April 28, 2026.

Who Can Join the Study?

Must be able to give signed informed consent, agreeing to follow the study’s requirements and restrictions.
Must have normal organ and bone marrow function, checked within 28 days before starting the study treatment.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which means being fully active or having some symptoms but being able to carry out light work.
Must have a life expectancy of at least 6 months, as judged by the study doctor.
Must provide a sample of tumor tissue, either from a previous biopsy or a new one, to check specific genetic information. This must be confirmed before joining the study.
Male patients must use a condom during treatment and for 3 months after the last dose when having sexual intercourse with a pregnant woman or a woman who can become pregnant. Female partners should also use a highly effective form of birth control if they can become pregnant. Male patients should not donate sperm during treatment and for 3 months after the last dose.
Must provide signed and dated written consent before any study-specific procedures, sampling, and analyses.
For optional genetic and biomarker research, must provide informed consent before sample collection. Declining this optional research will not affect participation in other parts of the study.
Must be at least 18 years old (or 19 in South Korea) at the time of signing the consent form. In Japan, if under 20, consent must also be obtained from a legally acceptable representative.
Must have prostate adenocarcinoma confirmed by tissue examination.
Must have metastatic status, meaning at least one confirmed spread of cancer to other parts of the body, shown on a bone scan or CT/MRI scan.
Must be in the first stage of metastatic castration-resistant prostate cancer (mCRPC).
Must be undergoing ongoing androgen deprivation therapy, which reduces male hormones, with specific hormone levels checked within 28 days before joining the study. This therapy should continue throughout the study.
Must be a candidate for abiraterone therapy, with documented evidence of disease progression.

Who Cannot Join the Study?

Patients who have received prior cytotoxic chemotherapy. This is a type of cancer treatment that uses drugs to kill cancer cells.
Patients who have received prior NHA. NHA stands for Novel Hormonal Agents, which are newer treatments that affect hormone levels to treat prostate cancer.
Patients who are not male. This study is only for male patients.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care, like children or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Urocentrum Praha s.r.o.	Prague	Czechia
Privatna Urologicka Ambulancia s.r.o.	Trencin	Slovakia
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Medikard s.r.o.	Presov	Slovakia
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Fakultni Thomayerova nemocnice	Prague	Czechia
Ffmiqact njrthcoux Mqfxd a Hahtsyn	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	12.02.2024
Czechia	Not recruiting	12.02.2024
France	Not recruiting	12.02.2024
Italy	Not recruiting	12.02.2024
Slovakia	Not recruiting	12.02.2024
The Netherlands	Not recruiting	12.02.2024

Trial locations

Investigated drugs:

Olaparib is a medication used in this trial to treat men with metastatic castration-resistant prostate cancer. It works by interfering with the cancer cells’ ability to repair their DNA, which can help to slow down or stop the growth of the cancer.

Abiraterone is another medication used in the trial. It helps to lower the levels of male hormones in the body, which can fuel the growth of prostate cancer. By reducing these hormone levels, abiraterone can help to slow the progression of the disease.

Investigated diseases:

Hormone-refractory prostate cancer

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread despite treatments that lower testosterone levels. It is characterized by the cancer’s ability to metastasize, or spread, to other parts of the body, such as bones and lymph nodes. The disease progresses as the cancer cells become resistant to hormonal therapies that are typically used to control prostate cancer. Patients may experience symptoms related to the spread of cancer, such as bone pain or urinary issues. Over time, the cancer may lead to further complications as it affects more areas of the body. The progression of the disease is often monitored through imaging studies and clinical assessments.

Trial ID:

2024-511144-86-00

Protocol code:

PROpel D081SC00001

NCT ID:

NCT03732820

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Olaparib and Abiraterone for Men with Advanced Prostate Cancer Resistant to Hormone Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?