AzTrials
AzTrials

Metastatic Castration-resistant Prostate CancerPhase 3NCT03732820

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

A Phase 3 study testing olaparib and abiraterone acetate in people with Metastatic Castration-resistant Prostate Cancer, run by AstraZeneca at 132 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years, men only
What is being tested?
olaparib and abiraterone acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
895 participants
Where
132 sitesin 17 countries
Study dates
31 Oct 2018to 5 Feb 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
  • 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.
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  • 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.
  • Histologically or cytologically confirmed prostate adenocarcinoma.
  • 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.
  • First-line metastatic castration-resistant prostate cancer (mCRPC).
  • 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.
  • Candidate for abiraterone therapy with documented evidence of progressive disease.
  • Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with no deterioration over the previous 2 weeks.
  • The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.
  • 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.
  • 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.

Who cannot join

  • Has a known additional malignancy that has had progression or has required active treatment in the last 5 years.
  • Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).
  • 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.
  • Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure.
  • Prior revascularisation procedure (significant coronary, carotid, or peripheral artery stenosis).
  • Uncontrolled hypertension (systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)).
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  • History of uncontrolled pituitary or adrenal dysfunction.
  • Active infection or other medical condition that would make prednisone/prednisolone use contraindicated.
  • Any chronic medical condition requiring a systemic dose of corticosteroid >10 milligrams (mg) prednisone/prednisolone per day.
  • Patients who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
  • Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAEs] grade >2) caused by previous cancer therapy, excluding alopecia.
  • Patients with brain metastases. A scan to confirm the absence of brain metastases is not required.
  • 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.
  • Patients who are unevaluable for both bone and soft tissue progression
  • Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Immunocompromised patients
  • Patients with known active hepatitis infection (ie, hepatitis B or C).
  • Any previous treatment with Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) inhibitor, including olaparib.
  • 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.
  • Any previous exposure to a Cytochrome P450 (CYP) 17 (17α-hydroxylase/C17,20-lyase) inhibitor (eg, abiraterone, orteronel).
  • 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.
  • 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.
  • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • Participation in another clinical study with an investigational product or investigational medical devices within 1 month of randomisation.
  • 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.
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the study site).
  • 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.
  • Previous randomisation in the present study.

Trial locations and contacts

132 sites in 17 countries.

132 sites in 17 countries

United States28 sites

  • Research Site

    Anchorage, Alaska, 99503

  • Research Site

    Birmingham, Alabama, 35209

  • Research Site

    Bozeman, Montana, 59715

  • Research Site

    Brooklyn, New York, 11220

  • Research Site

    Charleston, South Carolina, 29425

  • Research Site

    Clovis, California, 93611

  • Research Site

    Denver, Colorado, 80211

  • Research Site

    Detroit, Michigan, 48202

  • Research Site

    Durham, North Carolina, 27710

  • Research Site

    Grand Rapids, Michigan, 49503

  • Research Site

    Jeffersonville, Indiana, 47130

  • Research Site

    Lisle, Illinois, 60532

  • Research Site

    Los Angeles, California, 90027

  • Research Site

    Los Angeles, California, 90073

  • Research Site

    Milwaukee, Wisconsin, 53226

  • Research Site

    Myrtle Beach, South Carolina, 29572

  • Research Site

    New Hyde Park, New York, 11042

  • Research Site

    New Orleans, Louisiana, 70112

  • Research Site

    Omaha, Nebraska, 68130

  • Research Site

    Paramus, New Jersey, 07652

  • Research Site

    Philadelphia, Pennsylvania, 19111

  • Research Site

    Rochester, New York, 14642

  • Research Site

    Sacramento, California, 95817

  • Research Site

    San Diego, California, 92123

  • Research Site

    St Louis, Missouri, 63106

  • Research Site

    Syracuse, New York, 13210

  • Research Site

    Tucson, Arizona, 85704

  • Research Site

    Tucson, Arizona, 85741

Other trials in United States

Japan18 sites

  • Research Site

    Bunkyō City, 113-8431

  • Research Site

    Hirakata-shi, 573-1191

  • Research Site

    Kanazawa, 920-8641

  • Research Site

    Kashihara-shi, 634-8522

  • Research Site

    Kawagoe-shi, 350-8550

  • Research Site

    Kita-gun, 761-0793

  • Research Site

    Kyoto, 606-8507

  • Research Site

    Maebashi, 371-8811

  • Research Site

    Miyazaki, 889-1692

  • Research Site

    Nagoya, 466-8560

  • Research Site

    Osaka, 541-8567

  • Research Site

    Osaka, 545-8586

  • Research Site

    Osakasayama-shi, 589-8511

  • Research Site

    Sagamihara-shi, 252-0375

  • Research Site

    Sakura-shi, 285-8741

  • Research Site

    Shinjuku-ku, 160-8582

  • Research Site

    Toon-shi, 791-0295

  • Research Site

    Yokohama, 232-0024

Other trials in Japan

Canada10 sites

  • Research Site

    Calgary, Alberta, T2V 1P9

  • Research Site

    Edmonton, Alberta, T6G 1Z2

  • Research Site

    Greenfield Park, Quebec, J4V 2H1

  • Research Site

    Halifax, Nova Scotia, B3H 1V7

  • Research Site

    Kelowna, British Columbia, V1Y 5L3

  • Research Site

    London, Ontario, N6A 5W9

  • Research Site

    Montreal, Quebec, H2X 3E4

  • Research Site

    Montreal, Quebec, H3T 1E2

  • Research Site

    Toronto, Ontario, M4N 3M5

  • Research Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany10 sites

  • Research Site

    Bergisch Gladbach, 51465

  • Research Site

    Bremen, 28277

  • Research Site

    Cologne, 50968

  • Research Site

    Duisburg, 47169

  • Research Site

    Freiburg im Breisgau, 79106

  • Research Site

    Heinsberg, 52525

  • Research Site

    Mettmann, 40822

  • Research Site

    Nuremberg, 90419

  • Research Site

    Nürtingen, 72622

  • Research Site

    Ulm, 89081

Other trials in Germany

Australia8 sites

  • Research Site

    Box Hill, 3128

  • Research Site

    Darlinghurst, 2010

  • Research Site

    Greenslopes, 4120

  • Research Site

    Herston, 4029

  • Research Site

    Kingswood, 2747

  • Research Site

    Kurralta Park, 5037

  • Research Site

    St Albans, 3021

  • Research Site

    Waratah, 2298

Other trials in Australia

Brazil8 sites

  • Research Site

    Belo Horizonte, 30110-022

  • Research Site

    Curitiba, 80810-050

  • Research Site

    Fortaleza, 60336-232

  • Research Site

    Porto Alegre, 91350-200

  • Research Site

    Rio de Janeiro, 22793-080

  • Research Site

    São José do Rio Preto, 15090-000

  • Research Site

    São Paulo, 01221-020

  • Research Site

    São Paulo, 04266-010

Other trials in Brazil

France6 sites

  • Research Site

    Angers, 49033

  • Research Site

    Besançon, 25030

  • Research Site

    Caen, 14076

  • Research Site

    Pierre-Bénite, 69495

  • Research Site

    Quimper, 29107

  • Research Site

    Vandœuvre-lès-Nancy, 54519

Other trials in France

South Korea6 sites

  • Research Site

    Daegu, 41404

  • Research Site

    Goyang-si, 10408

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06591

Other trials in South Korea

Spain6 sites

  • Research Site

    Barcelona, 08036

  • Research Site

    Girona, 17007

  • Research Site

    Madrid, 08035

  • Research Site

    Madrid, 28041

  • Research Site

    Málaga, 29010

  • Research Site

    Seville, 41009

Other trials in Spain

Turkey (Türkiye)6 sites

  • Research Site

    Adana, 01060

  • Research Site

    Ankara, 06590

  • Research Site

    Ankara, 06800

  • Research Site

    Cordaleo, 35575

  • Research Site

    Istanbul, 34030

  • Research Site

    Izmir, 35360

Other trials in Turkey (Türkiye)

Italy5 sites

  • Research Site

    Milan, 20133

  • Research Site

    Milan, 20141

  • Research Site

    Naples, 80131

  • Research Site

    Orbassano, 10043

  • Research Site

    Pavia, 27100

Other trials in Italy

United Kingdom5 sites

  • Research Site

    Guildford, GU2 7WG

  • Research Site

    Manchester, M20 4BX

  • Research Site

    Sheffield, S10 2SJ

  • Research Site

    Southampton, SO16 6YD

  • Research Site

    Swansea, SA2 8QA

Other trials in United Kingdom

Chile4 sites

  • Research Site

    Santiago, 7500787

  • Research Site

    Santiago, 7520349

  • Research Site

    Temuco, 4781156

  • Research Site

    Viña del Mar, 2540488

Other trials in Chile

Czechia4 sites

  • Research Site

    Brno, 656 53

  • Research Site

    Prague, 120 00

  • Research Site

    Prague, 140 59

  • Research Site

    Prague, 150 06

Other trials in Czechia

Slovakia4 sites

  • Research Site

    Bratislava, 851 05

  • Research Site

    Prešov, 08001

  • Research Site

    Šaľa, 92701

  • Research Site

    Trenčín, 911 01

Other trials in Slovakia

Netherlands3 sites

  • Research Site

    Hilversum, 1213 XZ

  • Research Site

    Nijmegen, 6525 GA

  • Research Site

    Tilburg, 5042 AD

Other trials in Netherlands

Belgium1 site

  • Research Site

    Ghent, 9000

Other trials in Belgium

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)

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.

Read the detailed description

PROpel is a phase III study evaluating the efficacy, safety, and tolerability of olaparib versus placebo when given in addition to abiraterone to patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) for metastatic castration-resistant prostate cancer (mCRPC) (first-line setting).

Approximately 720 patients globally were planned to be randomized in PROpel in a 1:1 ratio to treatment with either olaparib and abiraterone or placebo and abiraterone. Enrolment had completed with a total of 796 patients randomised. Following the completion of global enrolment, the China cohort will randomise approximately 108 additional patients at sites in China, also in a 1:1 ratio.

Patients will receive oral treatment with olaparib 300 mg twice daily + abiraterone 1000 mg once daily or placebo twice daily + abiraterone 1000 mg once daily. Patients in both treatment groups will also receive either prednisone or prednisolone 5 mg twice daily.

Being tested
olaparib, abiraterone acetate
Keywords
metastatic castration-resistant prostate cancer (mCRPC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • olaparibDrug

    Also called Lynparza

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

  • abiraterone acetateDrug

    Also called Zytiga

    1000 milligrams (mg) once daily

Study groups in NCT03732820
Study groupRoleWhat they receive
olaparib plus abirateroneExperimentalOlaparib 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.
Receives: Drug: olaparib; Drug: abiraterone acetate
placebo plus abirateronePlacebo comparatorPlacebo 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.
Receives: Drug: abiraterone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    An rPFS event is defined as progression determined by Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST 1.1] and/or Prostate Cancer Working Group 3 [PCWG-3] or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy prior to progression.

    Per RECIST v1.1, progression is defined as the sum of TLs has a 20% and absolute ≥ 5mm increase from nadir, and/or unequivocal progression in any non target lesions, and/or any new lesion identified.

    Per PCWG3, progression on a bone scan is defined as 2 or more new lesions observed from the first visit after baseline compared to baseline, or from all other visits compared to first visit after baseline. A confirmatory scan is required.

    Measured: Assessed from date of randomisation to data cut off (DCO1): 30Jul2021 (Approx. 2 years 9 months)

Secondary outcomes (8)

  1. Number of Participants With Overall Survival (OS) Event

    An OS event is defined as death by any cause, regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy.

    Measured: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months). DCO3 is the final data cut-off for the OS analysis and therefore no further updates will be made.

  2. Number of Participants With Time to First Subsequent Anticancer Therapy or Death (TFST) Event

    A TFST (excluding radiotherapy) event is defined as the start of the first subsequent anticancer therapy after discontinuation of randomised treatment or death from any cause.

    Measured: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

  3. Number of Participants With Time to Pain Progression (TTPP) Event

    A TTPP event is defined as pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 (range 0-10, a higher score indicates worse pain) and opiate analgesic use (Analgesic quantification algorithm [AQA] score, range 0-7, a higher score indicates increased opioid use). For patients who are asymptomatic at baseline (average worst pain score of 0 and not taking opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits or initiation of opioid use; For patients who are symptomatic at baseline (average worst pain score >0 and/or receiving opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits and an average worst pain score ≥4, and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of ≥2), or increase in opioid use (≥1-point increase, or ≥2-point increase if the starting value is 0) at 2 consecutive follow-up visits.

    Measured: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

  4. Number of Participants With Opiate Use

    An event for opiate use is defined as the first opiate use for cancer related pain.

    Measured: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

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

    An SSRE event is defined as the first sympomatic skeletal-related event defined by

    • Use of radiation therapy to prevent or relieve skeletal symptoms.
    • Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).

    Measured: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

  6. Number of Participants With Second Progression or Death (PFS2) Event

    An event for PFS2 is defined as the second progression on next-line anticancer therapy or death, whichever occurs earlier.

    Measured: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

  7. Brief Pain Inventory-Short Form (BPI-SF)

    The BPI-SF is a validated, 15-item domain-specific instrument designed to assess the severity of pain and the impact/interference of pain on daily functions. BPI-SF worst pain, pain severity and pain interference score changes can be a minimum of -10 and a maximum of 10. A negative change from baseline value indicates improvement.

    Measured: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

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

    Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) total score and Functional Assessment of Cancer Therapy-General (FACT-G) total score.

    Total FACT-P score is the sum of Physical Well-being (PWB), Social Well-being (SWB), Emotional Well-being (EWB), Functional Well-being (FWB) and Prostate cancer subscale (PCS). FACT-P total score change from baseline values can be a minimum of -156 and a maximum of 156. A positive value indicates improvement.

    FACT-G total score is the sum of PWB, SWB, EWB and FWB. FACT-G Total score change from baseline values can be a minimum of -108 and a maximum of 108. A positive value indicates improvement.

    Measured: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start31 Oct 2018
  3. Primary completion30 Jul 2021
  4. Study completion5 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
895 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03732820
Sponsor's protocol ID
D081SC00001
Other IDs
2018-002011-10, 2018
Status last verified
Aug 2026
First submitted
28 Sep 2018
Last updated
18 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Armstrong AJ, Saad F, Oya M, Shore N, Procopio G, Arslan C, Mehra N, Brown E, Joung JY, Sugimoto M, Ozguroglu M, Gedye C, Sartor O, Poehlein C, Qiu P, Liu YZ, Li X, Harrington EA, McGuinness D, Kang J, Barnicle A, Clarke N. Detection of Homologous Recombination Repair Gene Mutations by Tumor Tissue and Circulating Tumor DNA Testing in Prostate Cancer in the Phase III PROpel Trial. JCO Precis Oncol. 2026 May;10(5):e2501109. doi: 10.1200/PO-25-01109. Epub 2026 May 11.

    PubMed 42114035

  • Armstrong AJ, Saad F, Oya M, Vianna K, Ozguroglu M, Gedye C, Buchschacher GL Jr, Lee JY, Emmenegger U, Navratil J, Virizuela JA, Salazar A, Maillet D, Uemura H, Hosius C, McGuinness D, Degboe A, Clarke N. Patient-reported Outcomes for Men with Metastatic Castration-resistant Prostate Cancer Who Received Olaparib plus Abiraterone Versus Placebo plus Abiraterone in the Phase 3 PROpel Study. Eur Urol Oncol. 2026 Feb;9(1):80-92. doi: 10.1016/j.euo.2025.09.010. Epub 2025 Nov 17.

    PubMed 41253648

  • Oya M, Joung JY, Lee JY, Sugimoto M, Choi YD, Hong JH, Uemura H, Nishimura K, Tsumura H, Kawakami S, Hirayama Y, Kwon TG, Kwak C, Suzuki H, Fujita T, Nii M, McGuinness D, Dujka M, Poehlein C, Saad F, Clarke N. Olaparib Plus Abiraterone in Asian Patients With Metastatic Castration-Resistant Prostate Cancer: PROpel Subset Analysis. Cancer Sci. 2025 Jun;116(6):1638-1647. doi: 10.1111/cas.16459. Epub 2025 Mar 18.

    PubMed 40099663

  • Heiss BL, Chang E, Gao X, Truong T, Brave MH, Bloomquist E, Shah A, Hamed S, Kraft J, Chiu HJ, Ricks TK, Tilley A, Pierce WF, Tang L, Abukhdeir A, Kalavar S, Philip R, Tang S, Pazdur R, Amiri-Kordestani L, Kluetz PG, Suzman DL. US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2024 May 20;42(15):1851-1860. doi: 10.1200/JCO.23.02182. Epub 2024 Mar 7.

    PubMed 38452327

  • Clarke NW, Armstrong AJ, Thiery-Vuillemin A, Oya M, Shore N, Loredo E, Procopio G, de Menezes J, Girotto G, Arslan C, Mehra N, Parnis F, Brown E, Schlurmann F, Joung JY, Sugimoto M, Virizuela JA, Emmenegger U, Navratil J, Buchschacher GL, Poehlein C, Harrington EA, Desai C, Kang J, Saad F. Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer. NEJM Evid. 2022 Sep;1(9):EVIDoa2200043. doi: 10.1056/EVIDoa2200043. Epub 2022 Jun 3.

    PubMed 38319800

  • Fallah J, Xu J, Weinstock C, Brave MH, Bloomquist E, Fiero MH, Schaefer T, Pathak A, Abukhdeir A, Bhatnagar V, Chiu HJ, Ricks T, John C, Hamed S, Lee C, Pierce WF, Kalavar S, Philip R, Tang S, Amiri-Kordestani L, Pazdur R, Kluetz PG, Suzman D. FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2024 Feb 10;42(5):605-613. doi: 10.1200/JCO.23.01868. Epub 2023 Dec 21.

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  • Saad F, Clarke NW, Oya M, Shore N, Procopio G, Guedes JD, Arslan C, Mehra N, Parnis F, Brown E, Schlurmann F, Joung JY, Sugimoto M, Sartor O, Liu YZ, Poehlein C, Barker L, Del Rosario PM, Armstrong AJ. Olaparib plus abiraterone versus placebo plus abiraterone in metastatic castration-resistant prostate cancer (PROpel): final prespecified overall survival results of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Oct;24(10):1094-1108. doi: 10.1016/S1470-2045(23)00382-0. Epub 2023 Sep 12.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing olaparib and abiraterone acetate in people with Metastatic Castration-resistant Prostate Cancer, run by AstraZeneca at 132 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, Japan, Canada, Germany, Australia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment (time frame: Assessed from date of randomisation to data cut off (DCO1): 30Jul2021 (Approx. 2 years 9 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03732820, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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