Uno studio sulla sopravvivenza libera delle metastasi con saruparib vs placebo aggiunto a un RT/ADT standard negli uomini con carcinoma prostatico ad alto rischio con una mutazione BRCA (EvoPAR-PR02)
13 ottobre 2026 aggiornato da: AstraZeneca
Uno studio randomizzato, in doppio cieco, controllato con placebo, di fase III sul saruparib adiuvante (AZD5305) in pazienti con carcinoma prostatico ad alto rischio localizzato BRCAM che ricevevano radioterapia con terapia di privazione degli androgeni (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).
Panoramica dello studio
Stato
Stato
Reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
700
Fase
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: AstraZeneca Clinical Study Information Center
- Numero di telefono: 1-877-240-9479
- Email: information.center@astrazeneca.com
Luoghi di studio
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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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San Miguel de Tucumán, Argentina, 4000
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Viedma, Argentina, R8500ACE
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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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Woolloongabba, Australia, 4102
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Linz, Austria, 4020
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Vienna, Austria, 1090
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Vienna, Austria, 1020
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Brussels, Belgio, 1070
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Jette, Belgio, 1090
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Leuven, Belgio, 3000
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Roeselare, Belgio, 8800
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Busan, Corea del Sud, 49241
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Daegu, Corea del Sud, 41404
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Goyang-si, Corea del Sud, 10408
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Seongnam-si, Corea del Sud, 13620
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Seoul, Corea del Sud, 03080
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Seoul, Corea del Sud, 06351
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Seoul, Corea del Sud, 5505
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Seoul, Corea del Sud, 06591
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Helsinki, Finlandia, 00290
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Helsinki, Finlandia, FI-00180
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Kuopio, Finlandia, 70210
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Oulu, Finlandia, 90029
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Tampere, Finlandia, FI-33521
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Turku, Finlandia, 20520
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Angers, Francia, 49100
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Bordeaux, Francia, 33000
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Caen, Francia, 14076
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Le Mans, Francia, 72000
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Marseille, Francia, 13273
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Tours, Francia, 37044
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Tucson, Arizona, Stati Uniti, 85741
- Ritirato
- Research Site
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California
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La Jolla, California, Stati Uniti, 92037
- Reclutamento
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La Jolla, California, Stati Uniti, 92093
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Los Angeles, California, Stati Uniti, 90048
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San Diego, California, Stati Uniti, 92123
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San Luis Obispo, California, Stati Uniti, 93401
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Colorado
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Lakewood, Colorado, Stati Uniti, 80215
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Florida
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Hialeah, Florida, Stati Uniti, 33016
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Jacksonville, Florida, Stati Uniti, 32224
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Tallahassee, Florida, Stati Uniti, 32308
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Tampa, Florida, Stati Uniti, 33612
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Georgia
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Newnan, Georgia, Stati Uniti, 30265
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
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Chicago Ridge, Illinois, Stati Uniti, 60415
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Lake Barrington, Illinois, Stati Uniti, 60010
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Indiana
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Greenwood, Indiana, Stati Uniti, 46143
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Jeffersonville, Indiana, Stati Uniti, 47130
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Maryland
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Bethesda, Maryland, Stati Uniti, 20817
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Towson, Maryland, Stati Uniti, 21204
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Massachusetts
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Plymouth, Massachusetts, Stati Uniti, 02360
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
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Voorhees Township, New Jersey, Stati Uniti, 08043
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New York
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Albany, New York, Stati Uniti, 12206
- Ritirato
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New York, New York, Stati Uniti, 10065
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Syracuse, New York, Stati Uniti, 13210
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Ohio
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Columbus, Ohio, Stati Uniti, 43230
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Oregon
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Springfield, Oregon, Stati Uniti, 97477
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti, 17033
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Lancaster, Pennsylvania, Stati Uniti, 17601
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Pittsburgh, Pennsylvania, Stati Uniti, 15212
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
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South Carolina
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Myrtle Beach, South Carolina, Stati Uniti, 29572
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37209
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Texas
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Austin, Texas, Stati Uniti, 78745
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Austin, Texas, Stati Uniti, 78705
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Houston, Texas, Stati Uniti, 77074
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San Antonio, Texas, Stati Uniti, 78229
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Spring, Texas, Stati Uniti, 77380
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
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Virginia
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Norfolk, Virginia, Stati Uniti, 23502
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Roanoke, Virginia, Stati Uniti, 24014
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Virginia Beach, Virginia, Stati Uniti, 23462
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Washington
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Seattle, Washington, Stati Uniti, 98109
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Gothenburg, Svezia, 413 45
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Malmö, Svezia, 205 02
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Stockholm, Svezia, 141 86
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Stockholm, Svezia, 112 81
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Umeå, Svezia, 901 85
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Uppsala, Svezia, 75185
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Bangkok, Tailandia, 10210
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Bangkok, Tailandia, 10400
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Bangkok, Tailandia, 10700
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Khon Kaen, Tailandia, 40002
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Muang, Tailandia, 50200
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Pathum Thani, Tailandia, 12120
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Songkhla, Tailandia, 90110
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Kaohsiung City, Taiwan, 83301
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 43503
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Tainan, Taiwan, 704
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Taipei, Taiwan, 112
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Taipei, Taiwan, 110
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Taipei, Taiwan, 10055
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Taoyuan, Taiwan, 333
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Ankara, Turchia (Türkiye), 06800
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Ankara, Turchia (Türkiye), 06620
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Ankara, Turchia (Türkiye), 06010
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Ankara, Turchia (Türkiye), 06520
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Cordaleo, Turchia (Türkiye), 35575
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Diyarbakır, Turchia (Türkiye), 21280
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Istanbul, Turchia (Türkiye), 34722
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Istanbul, Turchia (Türkiye), 34098
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Istanbul, Turchia (Türkiye), 34010
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Izmir, Turchia (Türkiye), 35040
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Sakarya, Turchia (Türkiye), 54290
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Seyhan, Turchia (Türkiye), 01130
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Şahinbey, Turchia (Türkiye), 27310
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Budapest, Ungheria, 1122
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Budapest, Ungheria, 1082
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Budapest, Ungheria, H-1145
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Debrecen, Ungheria, 4032
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Gyula, Ungheria, 5700
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Győr, Ungheria, 9024
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Zalaegerszeg, Ungheria, 8900
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Maschio
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
4
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Cohort A: Saruparib (AZD5305) + Physician's Choice ADT
Participants will receive saruparib along with ADT. |
Saruparib will be administered orally.
Altri nomi:
Standard of care ADT will be administered. |
|
Comparatore placebo: 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. |
|
Sperimentale: 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.
Altri nomi:
Standard of care ADT will be administered. Abiraterone will be administered orally in combination with prednisone/prednisolone. |
|
Comparatore placebo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Metastasis-free survival (MFS)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Collaboratori
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
6 agosto 2025
Completamento primario (Stimato)
Completamento primario
31 marzo 2033
Completamento dello studio (Stimato)
Completamento dello studio
30 aprile 2036
Date di iscrizione allo studio
Primo inviato
Primo inviato
30 aprile 2025
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
30 aprile 2025
Primo Inserito (Effettivo)
Primo Inserito
1 maggio 2025
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
14 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 ottobre 2026
Ultimo verificato
Ultimo verificato
1 ottobre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Neoplasie genitali, maschio
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie genitali, maschio
- Malattie della prostata
- Malattie urogenitali maschili
- Neoplasie prostatiche
- Effetti fisiologici dei farmaci
- Ormoni, sostituti ormonali e antagonisti ormonali
- Antagonisti ormonali
- Azioni farmacologiche
- Azioni e usi chimici
- Composti policiclici
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Incintadienetrioli
- Incintadienediols
- Prednisone
- Prednisolone
- Antagonisti degli androgeni
- Abiraterone
- AZD5305
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- D9727C00001
- 2024-513586-39 (Altro identificatore: EU CT Number)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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.
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .