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Clinical Trials in Turkey / NCT03732820
Active, not recruiting Phase 3

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

NCT03732820 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 3
Started
2018-10-31
Last updated
2026-08-18

Condition(s) studied

Metastatic Castration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

olaparib →abiraterone acetate →

olaparib: 300 mg (2 x 150 milligrams (mg) tablets) twice daily

abiraterone acetate: 1000 milligrams (mg) once daily

Study summary

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

Eligibility

Sex
MALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol. 2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. 3. For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfill the following criteria: * Provision of informed consent for genetic research prior to collection of sample. * Provision of informed consent for biomarker research prior to collection of sample. If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study. 4. Patients must be ≥18 years of age (or ≥19 years of age in South Korea) at the time of signing the informed consent form. For patients enrolled in Japan who are \<20 years of age, written informed consent should be obtained from the patient and from his legally acceptable representative. 5. Histologically or cytologically confirmed prostate adenocarcinoma. 6. Metastatic status defined as at least 1 documented metastatic lesion on either a bone scan or a computed tomography(CT)/ magnetic resonance imaging (MRI) scan. 7. First-line metastatic castration-resistant prostate cancer (mCRPC). 8. Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral orchiectomy, with serum testosterone \<50 nanograms per decilitre (ng/dL) (\<2.0 nanomoles per litre (nmol/L)) within 28 days before randomisation. Patients receiving androgen deprivation therapy (ADT) at study entry should continue to do so throughout the study. 9. Candidate for abiraterone therapy with documented evidence of progressive disease. 10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment. 11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with no deterioration over the previous 2 weeks. 12. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months. 13. Prior to randomisation, sites must confirm availability of either an archival formalin fixed, paraffin embedded (FFPE) tumour tissue sample, or a new biopsy taken during the screening window, which meets the minimum pathology and sample requirements in order to enable homologous recombination repair (HRR) status subgroup analysis of the primary endpoint radiographic progression-free survival (rPFS). If there is not written confirmation of the availability of tumour tissue prior to randomisation, the patient is not eligible for the study. 14. Male patients must use a condom during treatment and for 3 months after the last dose of olaparib+abiraterone when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Exclusion Criteria: 1. Has a known additional malignancy that has had progression or has required active treatment in the last 5 years. 2. Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML). 3. Clinically significant cardiovascular disease Association Class II-IV heart failure or cardiac ejection fraction measurement of \<50% during screening as assessed by echocardiography or multigated acquisition scan. 4. Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure. 5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery stenosis). 6. Uncontrolled hypertension (systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)). 7. History of uncontrolled pituitary or adrenal dysfunction. 8. Active infection or other medical condition that would make prednisone/prednisolone use contraindicated. 9. Any chronic medical condition requiring a systemic dose of corticosteroid \>10 milligrams (mg) prednisone/prednisolone per day. 10. Patients who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. 11. Persistent toxicities (Common Terminology Criteria for Adverse Events \[CTCAEs\] grade \>2) caused by previous cancer therapy, excluding alopecia. 12. Patients with brain metastases. A scan to confirm the absence of brain metastases is not required. 13. Patients with spinal cord compression are excluded unless they are considered to have received definitive treatment for this and have evidence of clinically stable disease for 4 weeks. 14. Patients who are unevaluable for both bone and soft tissue progression 15. Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 16. Immunocompromised patients 17. Patients with known active hepatitis infection (ie, hepatitis B or C). 18. Any previous treatment with Polyadenosine 5'diphosphoribose \[poly (ADP ribose)\] polymerase (PARP) inhibitor, including olaparib. 19. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment. Patients who receive palliative radiotherapy need to stop radiotherapy 1 week before randomisation. 20. Any previous exposure to a Cytochrome P450 (CYP) 17 (17α-hydroxylase/C17,20-lyase) inhibitor (eg, abiraterone, orteronel). 21. Concomitant use of known strong Cytochrome P450 (CYP) 3A inhibitors (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. 22. Concomitant use of known strong Cytochrome P450 (CYP) 3A inducers (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine or St John's wort) or moderate Cytochrome P450 (CYP) 3A inducers (eg, bosentan, efavirenz or modafinil). The required period prior to starting study treatment is 5 weeks for phenobarbital and enzalutamide and 3 weeks for other agents. 23. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. 24. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT). 25. Participation in another clinical study with an investigational product or investigational medical devices within 1 month of randomisation. 26. History of hypersensitivity to olaparib or abiraterone, any of the excipients of olaparib or abiraterone, or drugs with a similar chemical structure or class to olaparib or abiraterone. 27. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the study site). 28. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. 29. Previous randomisation in the present study.

Primary outcome measure(s)

Trial sites (132)

FacilityCityRegionStatus
Research Site Birmingham Alabama
Research Site Anchorage Alaska
Research Site Tucson Arizona
Research Site Tucson Arizona
Research Site Clovis California
Research Site Los Angeles California
Research Site Los Angeles California
Research Site Sacramento California
Research Site San Diego California
Research Site Denver Colorado
Research Site Lisle Illinois
Research Site Jeffersonville Indiana
Research Site New Orleans Louisiana
Research Site Detroit Michigan
Research Site Grand Rapids Michigan
Research Site St Louis Missouri
Research Site Bozeman Montana
Research Site Omaha Nebraska
Research Site Paramus New Jersey
Research Site Brooklyn New York
Research Site New Hyde Park New York
Research Site Rochester New York
Research Site Syracuse New York
Research Site Durham North Carolina
Research Site Philadelphia Pennsylvania
Research Site Charleston South Carolina
Research Site Myrtle Beach South Carolina
Research Site Milwaukee Wisconsin
Research Site Box Hill Australia
Research Site Darlinghurst Australia
Research Site Greenslopes Australia
Research Site Herston Australia
Research Site Kingswood Australia
Research Site Kurralta Park Australia
Research Site St Albans Australia
Research Site Waratah Australia
Research Site Ghent Belgium
Research Site Belo Horizonte Brazil
Research Site Curitiba Brazil
Research Site Fortaleza Brazil

+ 92 more sites — see the full list on the official registry below.

On this site

📄 Lynparza (olaparib) drug profile →

More AstraZeneca trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03732820 on ClinicalTrials.gov ↗ ← All trials in Turkey