En studie av metastaser gratis overlevelse med saruparib vs placebo lagt til en standard RT/ADT hos menn med høyrisiko prostatakreft med en BRCA-mutasjon (EvoPAR-PR02)
13. oktober 2026 oppdatert av: AstraZeneca
En randomisert, dobbeltblind, placebokontrollert fase III-studie av adjuvans saruparib (AZD5305) hos pasienter med BRCAM lokalisert høyrisiko prostatakreft som fikk strålebehandling med androgenmangel (Evopar-prostate02).
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
Approximately, 700 adult participants with localised/locally advanced prostate cancer will be randomized in a 1:1 ratio to receive saruparib or placebo with ADT (+ abiraterone) in one of the following two cohorts:
Cohort A: 400 adult participants with newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer who have received primary RT and are receiving continuous ADT, and participants with high-risk biochemical recurrence (BCR) [including prostate-specific antigen (PSA) persistence] following a radical prostatectomy who have received salvage RT are receiving continuous ADT.
Cohort B: 300 adult participants with newly diagnosed very high-risk (locally advanced) prostate cancer who have received primary RT and who are receiving continuous ADT and abiraterone.
All participants will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of experts will be convened to confirm the safety and efficacy of Saruparib + ADT (+ abiraterone).
Studietype
Intervensjonell
Registrering (Antatt)
700
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
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CABA, Argentina, C1113AAE
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CABA, Argentina, 1426
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Ciudad de Buenos Aires, Argentina, 1181
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Ciudad de Buenos Aires, Argentina, 1426
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Ciudad de Buenos Aires, Argentina, C1419AHL
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Cuidad Autónoma de Buenos Aire, Argentina, C1426ANZ
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Córdoba, Argentina, 5000
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Córdoba, Argentina, X5008HHW
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La Plata, Argentina, 1900
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Pergamino, Argentina, B2700CPM
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Rosario, Argentina, S2000KZE
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Kingswood, Australia, 2747
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Murdoch, Australia, 6150
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Orange, Australia, 2800
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South Brisbane, Australia, 4101
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St Leonards, Australia, 2065
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Waratah, Australia, 2298
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Ghent, Belgia, 9000
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Jette, Belgia, 1090
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Kortrijk, Belgia, 8500
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Leuven, Belgia, 3000
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Libramont-Chevigny, Belgia, 6800
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Plymouth, Massachusetts, Forente stater, 02360
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Rochester, Minnesota, Forente stater, 55905
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Hackensack, New Jersey, Forente stater, 07601
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Albany, New York, Forente stater, 12206
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Columbus, Ohio, Forente stater, 43230
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Springfield, Oregon, Forente stater, 97477
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Hershey, Pennsylvania, Forente stater, 17033
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Pittsburgh, Pennsylvania, Forente stater, 15212
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Rhode Island
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Providence, Rhode Island, Forente stater, 02903
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Myrtle Beach, South Carolina, Forente stater, 29572
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Tennessee
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Nashville, Tennessee, Forente stater, 37209
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Austin, Texas, Forente stater, 78745
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Houston, Texas, Forente stater, 77074
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San Antonio, Texas, Forente stater, 78229
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Spring, Texas, Forente stater, 77380
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Utah
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Salt Lake City, Utah, Forente stater, 84112
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Norfolk, Virginia, Forente stater, 23502
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Roanoke, Virginia, Forente stater, 24014
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Virginia Beach, Virginia, Forente stater, 23462
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Washington
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Seattle, Washington, Forente stater, 98109
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Angers, Frankrike, 49100
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Bordeaux, Frankrike, 33000
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Caen, Frankrike, 14076
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Clermont-Ferrand, Frankrike, 63011
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Le Mans, Frankrike, 72000
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Marseille, Frankrike, 13273
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Montpellier, Frankrike, 34070
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Montpellier, Frankrike, 34298
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Nice, Frankrike, 06100
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Nîmes, Frankrike, 30029
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Paris, Frankrike, 75020
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Paris, Frankrike, 75970
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Paris, Frankrike, 75674
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Pierre-Bénite, Frankrike, 69310
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Rennes, Frankrike, 35000
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Saint-Herblain, Frankrike, 44805
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Saint-Priest-en-Jarez, Frankrike, 42270
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Strasbourg, Frankrike, 67200
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Tours, Frankrike, 37044
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Villejuif, Frankrike, 94805
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Afula, Israel, 18101
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Nahariya, Israel, 22100
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Petah Tikva, Israel, 49100
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Ramat Gan, Israel, 52621
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Chieti, Italia, 66100
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Genoa, Italia, 16132
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Milan, Italia, 20141
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Milan, Italia, 20133
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Roma, Italia, 00168
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Roma, Italia, 00144
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Rozzano, Italia, 20089
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Torino, Italia, 10126
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Verona, Italia, 37134
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Fukuoka, Japan, 812-8582
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Kamakura-shi, Japan, 247-8533
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Kawasaki-shi, Japan, 216-8511
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Kisarazu-shi, Japan, 292-8535
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Shanghai, Kina, 20032
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Pulau Pinang, Malaysia, 10450
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Trujillo, Peru, 13008
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Poznan, Polen, 61-731
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Warsaw, Polen, 04-073
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Madrid, Spania, 28040
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Madrid, Spania, 28041
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Málaga, Spania, 29010
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Málaga, Spania, 29009
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Oviedo, Spania, 33011
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Sabadell, Spania, 08208
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Santander, Spania, 39008
- Rekruttering
- Research Site
-
Valencia, Spania, 46014
- Rekruttering
- Research Site
-
Valencia, Spania, 46009
- Rekruttering
- Research Site
-
-
-
-
-
Aberdeen, Storbritannia, AB25 2ZN
- Rekruttering
- Research Site
-
Bristol, Storbritannia, BS2 8ED
- Rekruttering
- Research Site
-
Cambridge, Storbritannia, CB2 0QQ
- Rekruttering
- Research Site
-
Edinburgh, Storbritannia, EH4 2XU
- Rekruttering
- Research Site
-
Exeter, Storbritannia, EX2 5DW
- Rekruttering
- Research Site
-
Glasgow, Storbritannia, G12 0YN
- Rekruttering
- Research Site
-
Greater London, Storbritannia, SW3 6JJ
- Rekruttering
- Research Site
-
Guildford, Storbritannia, GU2 7XX
- Rekruttering
- Research Site
-
London, Storbritannia, NW3 2QG
- Rekruttering
- Research Site
-
London, Storbritannia, WC1N 3BG
- Rekruttering
- Research Site
-
London, Storbritannia, EC1M6BQ
- Tilbaketrukket
- Research Site
-
Manchester, Storbritannia, M20 4BX
- Rekruttering
- Research Site
-
Newcastle, Storbritannia, NE7 7DN
- Tilbaketrukket
- Research Site
-
Plymouth, Storbritannia, PL6 8DH
- Rekruttering
- Research Site
-
Preston, Storbritannia, PR2 9HT
- Tilbaketrukket
- Research Site
-
Romford, Storbritannia, RM7 0AG
- Rekruttering
- Research Site
-
-
-
-
-
Gothenburg, Sverige, 413 45
- Rekruttering
- Research Site
-
Malmö, Sverige, 205 02
- Rekruttering
- Research Site
-
Stockholm, Sverige, 141 86
- Rekruttering
- Research Site
-
Stockholm, Sverige, 112 81
- Tilbaketrukket
- Research Site
-
Umeå, Sverige, 901 85
- Rekruttering
- Research Site
-
Uppsala, Sverige, 75185
- Rekruttering
- Research Site
-
-
-
-
-
Busan, Sør -Korea, 49241
- Rekruttering
- Research Site
-
Daegu, Sør -Korea, 41404
- Rekruttering
- Research Site
-
Goyang-si, Sør -Korea, 10408
- Rekruttering
- Research Site
-
Seongnam-si, Sør -Korea, 13620
- Tilbaketrukket
- Research Site
-
Seoul, Sør -Korea, 03080
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 06351
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 5505
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 06591
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 3722
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 06273
- Rekruttering
- Research Site
-
-
-
-
-
Kaohsiung City, Taiwan, 83301
- Rekruttering
- Research Site
-
Taichung, Taiwan, 40705
- Rekruttering
- Research Site
-
Taichung, Taiwan, 43503
- Rekruttering
- Research Site
-
Tainan, Taiwan, 704
- Rekruttering
- Research Site
-
Taipei, Taiwan, 112
- Rekruttering
- Research Site
-
Taipei, Taiwan, 110
- Rekruttering
- Research Site
-
Taipei, Taiwan, 10055
- Rekruttering
- Research Site
-
Taoyuan, Taiwan, 333
- Rekruttering
- Research Site
-
-
-
-
-
Bangkok, Thailand, 10210
- Rekruttering
- Research Site
-
Bangkok, Thailand, 10400
- Rekruttering
- Research Site
-
Bangkok, Thailand, 10700
- Rekruttering
- Research Site
-
Khon Kaen, Thailand, 40002
- Rekruttering
- Research Site
-
Muang, Thailand, 50200
- Rekruttering
- Research Site
-
Pathum Thani, Thailand, 12120
- Rekruttering
- Research Site
-
Songkhla, Thailand, 90110
- Rekruttering
- Research Site
-
-
-
-
-
Ankara, Tyrkia (Türkiye), 06800
- Rekruttering
- Research Site
-
Ankara, Tyrkia (Türkiye), 06620
- Rekruttering
- Research Site
-
Ankara, Tyrkia (Türkiye), 06010
- Rekruttering
- Research Site
-
Ankara, Tyrkia (Türkiye), 06520
- Rekruttering
- Research Site
-
Cordaleo, Tyrkia (Türkiye), 35575
- Rekruttering
- Research Site
-
Diyarbakır, Tyrkia (Türkiye), 21280
- Rekruttering
- Research Site
-
Istanbul, Tyrkia (Türkiye), 34722
- Rekruttering
- Research Site
-
Istanbul, Tyrkia (Türkiye), 34098
- Rekruttering
- Research Site
-
Istanbul, Tyrkia (Türkiye), 34010
- Rekruttering
- Research Site
-
Izmir, Tyrkia (Türkiye), 35040
- Rekruttering
- Research Site
-
Sakarya, Tyrkia (Türkiye), 54290
- Rekruttering
- Research Site
-
Seyhan, Tyrkia (Türkiye), 01130
- Tilbaketrukket
- Research Site
-
Şahinbey, Tyrkia (Türkiye), 27310
- Rekruttering
- Research Site
-
-
-
-
-
Augsburg, Tyskland, 86156
- Rekruttering
- Research Site
-
Berlin, Tyskland, 10117
- Rekruttering
- Research Site
-
Braunschweig, Tyskland, 38126
- Rekruttering
- Research Site
-
Cologne, Tyskland, 50937
- Rekruttering
- Research Site
-
Dresden, Tyskland, 1307
- Rekruttering
- Research Site
-
Duisburg, Tyskland, 47169
- Rekruttering
- Research Site
-
Düsseldorf, Tyskland, 40226
- Rekruttering
- Research Site
-
Essen, Tyskland, 45147
- Rekruttering
- Research Site
-
Giessen, Tyskland, 35392
- Rekruttering
- Research Site
-
Gronau, Tyskland, 48599
- Har ikke rekruttert ennå
- Research Site
-
Göttingen, Tyskland, 37075
- Rekruttering
- Research Site
-
Hamburg, Tyskland, 20246
- Rekruttering
- Research Site
-
Herne, Tyskland, 44625
- Rekruttering
- Research Site
-
Kiel, Tyskland, 24105
- Tilbaketrukket
- Research Site
-
Lübeck, Tyskland, 23538
- Rekruttering
- Research Site
-
Marburg, Tyskland, 35043
- Rekruttering
- Research Site
-
Münster, Tyskland, 48149
- Rekruttering
- Research Site
-
Nuremberg, Tyskland, 90419
- Rekruttering
- Research Site
-
Nürtingen, Tyskland, 72622
- Rekruttering
- Research Site
-
Regensburg, Tyskland, 93053
- Rekruttering
- Research Site
-
Schwerin, Tyskland, 19049
- Rekruttering
- Research Site
-
Trier, Tyskland, 54292
- Rekruttering
- Research Site
-
Ulm, Tyskland, 89081
- Rekruttering
- Research Site
-
Würzburg, Tyskland, 97080
- Rekruttering
- Research Site
-
-
-
-
-
Budapest, Ungarn, 1122
- Rekruttering
- Research Site
-
Budapest, Ungarn, 1082
- Rekruttering
- Research Site
-
Budapest, Ungarn, H-1145
- Tilbaketrukket
- Research Site
-
Debrecen, Ungarn, 4032
- Rekruttering
- Research Site
-
Gyula, Ungarn, 5700
- Rekruttering
- Research Site
-
Győr, Ungarn, 9024
- Rekruttering
- Research Site
-
Zalaegerszeg, Ungarn, 8900
- Rekruttering
- Research Site
-
-
-
-
-
Graz, Østerrike, 8036
- Rekruttering
- Research Site
-
Innsbruck, Østerrike, 6020
- Rekruttering
- Research Site
-
Linz, Østerrike, 4020
- Rekruttering
- Research Site
-
Vienna, Østerrike, 1090
- Har ikke rekruttert ennå
- Research Site
-
Vienna, Østerrike, 1020
- Rekruttering
- Research Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
- Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.
- Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
- Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.
- Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
- Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.
- Minimum life expectancy of 12 months.
- Adequate organ and bone marrow function as described in study protocol.
- All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within 10 months of initial diagnosis (de novo or BCR). Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent. Use of metastases-directed therapy, as part of the RT radiation plan, is permitted as localised RT treatment for a metastatic lesion(s) outside the pelvis.
- All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.
- Participants must not father children or donate sperm from signing informed consent form (ICF), during the study intervention and for 6 months after the last dose of study intervention.
- Participants must use a condom (with spermicide - where permitted) from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
Exclusion Criteria:
- Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Participants with any known predisposition to bleeding [e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy].
- Any history of persisting (> 2 weeks) severe cytopenia due to any cause.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and/or abiraterone.
- History of another primary malignancy, with exceptions.
- Persistent toxicities [Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2] caused by previous anticancer therapy.
- Cardiac criteria, including history of arrhythmia and cardiovascular disease.
- Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
- Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
- Active tuberculosis infection.
- Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.
- Prior treatment within 14 days with blood product support or growth factor support.
- Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib and abiraterone) or herbal supplements within 21 days or at least 5 half-lives (whichever is longer), of randomization.
- Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).
- Participants with a known hypersensitivity to saruparib or any excipients of these products.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohort A: Saruparib (AZD5305) + Physician's Choice ADT
Participants will receive saruparib along with ADT. |
Saruparib will be administered orally.
Andre navn:
Standard of care ADT will be administered. |
|
Placebo komparator: Cohort A: Placebo + Physician's Choice ADT
Participants will receive matching placebo to saruparib along with ADT. |
Standard of care ADT will be administered. Matching placebo to saruparib will be administered orally. |
|
Eksperimentell: Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT. |
Saruparib will be administered orally.
Andre navn:
Standard of care ADT will be administered. Abiraterone will be administered orally in combination with prednisone/prednisolone. |
|
Placebo komparator: Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
Participants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT. |
Standard of care ADT will be administered. Matching placebo to saruparib will be administered orally. Abiraterone will be administered orally in combination with prednisone/prednisolone. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Metastasis-free survival (MFS)
Tidsramme: Up to approximately 93 months
|
MFS is defined as the time from randomisation until the date of first appearance of distant metastases, confirmed by standard clinical imaging [computed tomography (CT)/ magnetic resonance imaging (MRI) and bone scan, or prostate-specific membrane antigen-positron emission tomography (PSMA-PET)], as assessed by blinded independent central review (BICR) or death due to any cause. |
Up to approximately 93 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to approximately 11 years
|
OS is defined as the time from randomisation until the date of death due to any cause. |
Up to approximately 11 years
|
|
MFS (CT/MRI and bone scan)
Tidsramme: Up to approximately 93 months
|
MFS is defined as the time from randomisation until the date of distant metastases, confirmed by conventional imaging (CT/MRI and bone scan), or death due to any cause. |
Up to approximately 93 months
|
|
MFS (PSMA-PET)
Tidsramme: Up to approximately 93 months
|
MFS is defined as the time from randomisation until the date of distant metastases, confirmed by PSMA-PET imaging or death due to any cause. |
Up to approximately 93 months
|
|
MFS (standard clinical imaging)
Tidsramme: Up to approximately 93 months
|
MFS is defined as the time from randomisation until the date of distant metastases, confirmed by standard clinical imaging (CT/MRI and bone scan or PSMA-PET), histology, or death due to any cause. |
Up to approximately 93 months
|
|
Time from randomisation to Progression Free Survival 2 (PFS2)
Tidsramme: Up to approximately 93 months
|
Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression [defined as radiographic progression, clinical progression, or prostate-specific antigen (PSA) progression] after initiation of first subsequent systemic treatment following the initial investigator-assessed progression or death. The date of second progression will be investigator assessed according to local standard clinical practice. |
Up to approximately 93 months
|
|
Time to biochemical recurrence
Tidsramme: Up to approximately 93 months
|
Time to biochemical recurrence is defined as the time from randomisation to biochemical recurrence per Phoenix criteria. |
Up to approximately 93 months
|
|
Prostate cancer-specific survival (PCSS)
Tidsramme: Up to approximately 11 years
|
PCSS is defined as the time from randomisation until the date of death due to the underlying prostate cancer. |
Up to approximately 11 years
|
|
Time to deterioration in urinary symptoms (TTDUS)
Tidsramme: Up to approximately 93 months
|
TTDUS is defined as the time from randomisation to deterioration in EORTC-QLQ-PR25 (US) subscale scores. |
Up to approximately 93 months
|
|
Time to deterioration in physical function (TTDPF)
Tidsramme: Up to approximately 93 months
|
TTDPF is defined as the time from randomisation to deterioration in EORTC-QLQ-C30 Physical Function subscale scores. |
Up to approximately 93 months
|
|
Plasma concentrations of saruparib
Tidsramme: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety). |
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
|
Area under the curve (AUC)
Tidsramme: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety). |
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
|
Maximum observed concentration (Cmax)
Tidsramme: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety). |
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
|
Time to Cmax (Tmax)
Tidsramme: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety). |
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
|
Number of participants with adverse events (AEs)
Tidsramme: Up to approximately 11 years
|
To assess the safety and tolerability of saruparib administered in combination with ADT alone (Cohort A) and in combination with ADT + abiraterone (Cohort B). |
Up to approximately 11 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. august 2025
Primær fullføring (Antatt)
31. mars 2033
Studiet fullført (Antatt)
30. april 2036
Datoer for studieregistrering
Først innsendt
30. april 2025
Først innsendt som oppfylte QC-kriteriene
30. april 2025
Først lagt ut (Faktiske)
1. mai 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Genitale neoplasmer, hanner
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kjønnssykdommer, mannlige
- Prostata sykdommer
- Mannlige urogenitale sykdommer
- Prostatiske neoplasmer
- Fysiologiske effekter av legemidler
- Hormoner, hormonsubstitutter og hormonantagonister
- Hormonantagonister
- Farmakologiske handlinger
- Kjemiske handlinger og bruk
- Polysykliske forbindelser
- Gravadienes
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Gravadienetrioler
- Gravadienedioler
- Prednison
- Prednisolon
- Androgenantagonister
- abirateron
- AZD5305
Andre studie-ID-numre
- D9727C00001
- 2024-513586-39 (Annen identifikator: EU CT Number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Tilgangskriterier for IPD-deling
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .