New drug cocktail shows promise in slowing advanced prostate cancer

NCT ID NCT03732820

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding olaparib to standard abiraterone therapy helps men with metastatic castration-resistant prostate cancer live longer without their cancer worsening. About 895 men who have not had chemotherapy or newer hormone drugs for this stage will receive either the combination or a placebo plus abiraterone. The main goal is to see if the combo delays cancer growth on scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: olaparib and abiraterone
What this could lead to: If successful, this combination could become a new first-line treatment that delays cancer progression and extends life for men with advanced prostate cancer.
What could go wrong: This is a late-stage trial, but the added benefit over existing therapy may be modest. Side effects from combining two drugs could be significant, and not all patients may respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

895 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

Contacts and locations

Locations

Research Site

Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Santiago, 7500787, Chile
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Santiago, 7520349, Chile
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Temuco, 4781156, Chile
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Viña del Mar, 2540488, Chile
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Brno, 656 53, Czechia
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Prague, 120 00, Czechia
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Prague, 140 59, Czechia
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Prague, 150 06, Czechia
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Angers, 49033, France
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Besançon, 25030, France
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Caen, 14076, France
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Pierre-Bénite, 69495, France
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Quimper, 29107, France
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Vandœuvre-lès-Nancy, 54519, France
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Bergisch Gladbach, 51465, Germany
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Bremen, 28277, Germany
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Cologne, 50968, Germany
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Duisburg, 47169, Germany
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Freiburg im Breisgau, 79106, Germany
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Heinsberg, 52525, Germany
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Mettmann, 40822, Germany
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Nuremberg, 90419, Germany
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Nürtingen, 72622, Germany
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Ulm, 89081, Germany
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Milan, 20133, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Orbassano, 10043, Italy
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Pavia, 27100, Italy
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Bunkyō City, 113-8431, Japan
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Hirakata-shi, 573-1191, Japan
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Kanazawa, 920-8641, Japan
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Kashihara-shi, 634-8522, Japan
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Kawagoe-shi, 350-8550, Japan
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Kita-gun, 761-0793, Japan
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Kyoto, 606-8507, Japan
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Maebashi, 371-8811, Japan
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Miyazaki, 889-1692, Japan
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Nagoya, 466-8560, Japan
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Osaka, 541-8567, Japan
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Osaka, 545-8586, Japan
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Osakasayama-shi, 589-8511, Japan
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Sagamihara-shi, 252-0375, Japan
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Sakura-shi, 285-8741, Japan
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Shinjuku-ku, 160-8582, Japan
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Toon-shi, 791-0295, Japan
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Yokohama, 232-0024, Japan
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Hilversum, 1213 XZ, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Tilburg, 5042 AD, Netherlands
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Bratislava, 851 05, Slovakia
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Prešov, 08001, Slovakia
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Šaľa, 92701, Slovakia
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Trenčín, 911 01, Slovakia
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Barcelona, 08036, Spain
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Girona, 17007, Spain
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Madrid, 08035, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Seville, 41009, Spain
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Adana, 01060, Turkey (Türkiye)
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Ankara, 06590, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Cordaleo, 35575, Turkey (Türkiye)
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Istanbul, 34030, Turkey (Türkiye)
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Izmir, 35360, Turkey (Türkiye)
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Guildford, GU2 7WG, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Swansea, SA2 8QA, United Kingdom
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Birmingham, Alabama, 35209, United States
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Anchorage, Alaska, 99503, United States
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Tucson, Arizona, 85704, United States
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Tucson, Arizona, 85741, United States
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Clovis, California, 93611, United States
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Los Angeles, California, 90027, United States
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Los Angeles, California, 90073, United States
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Sacramento, California, 95817, United States
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San Diego, California, 92123, United States
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Denver, Colorado, 80211, United States
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Lisle, Illinois, 60532, United States
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Jeffersonville, Indiana, 47130, United States
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New Orleans, Louisiana, 70112, United States
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Detroit, Michigan, 48202, United States
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Grand Rapids, Michigan, 49503, United States
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St Louis, Missouri, 63106, United States
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Bozeman, Montana, 59715, United States
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Omaha, Nebraska, 68130, United States
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Paramus, New Jersey, 07652, United States
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Brooklyn, New York, 11220, United States
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New Hyde Park, New York, 11042, United States
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Rochester, New York, 14642, United States
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Syracuse, New York, 13210, United States
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Durham, North Carolina, 27710, United States
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Philadelphia, Pennsylvania, 19111, United States
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Charleston, South Carolina, 29425, United States
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Myrtle Beach, South Carolina, 29572, United States
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Milwaukee, Wisconsin, 53226, United States
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Box Hill, 3128, Australia
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Darlinghurst, 2010, Australia
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Greenslopes, 4120, Australia
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Herston, 4029, Australia
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Kingswood, 2747, Australia
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Kurralta Park, 5037, Australia
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St Albans, 3021, Australia
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Waratah, 2298, Australia
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Ghent, 9000, Belgium
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Belo Horizonte, 30110-022, Brazil
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Curitiba, 80810-050, Brazil
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Fortaleza, 60336-232, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 22793-080, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01221-020, Brazil
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São Paulo, 04266-010, Brazil
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Calgary, Alberta, T2V 1P9, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada

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