RECRUITING Phase 3 ClinicalTrials.gov

A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT06952803

Registry updated: 2026-10-14

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Description

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).

Interventions

Saruparib (Drug)
Saruparib will be administered orally.
Placebo (Drug)
Matching placebo to saruparib will be administered orally.
Abiraterone + Prednisolone/Prednisone (Drug)
Abiraterone will be administered orally in combination with prednisone/prednisolone.
Androgen Deprivation Therapy (ADT) (Drug)
Standard of care ADT will be administered.

Eligibility criteria

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.

Conditions

Prostate Cancer

Locations

Research Site — Phoenix, Arizona, United States
Research Site — Tucson, Arizona, United States
Research Site — La Jolla, California, United States
Research Site — La Jolla, California, United States
Research Site — Los Angeles, California, United States
Research Site — San Diego, California, United States
Research Site — San Luis Obispo, California, United States
Research Site — Lakewood, Colorado, United States
Research Site — Hialeah, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Tallahassee, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Newnan, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Chicago Ridge, Illinois, United States
Research Site — Lake Barrington, Illinois, United States
Research Site — Greenwood, Indiana, United States
Research Site — Jeffersonville, Indiana, United States
Research Site — Bethesda, Maryland, United States
Research Site — Towson, Maryland, United States
Research Site — Plymouth, Massachusetts, United States
Research Site — Rochester, Minnesota, United States
Research Site — Hackensack, New Jersey, United States
Research Site — Voorhees Township, New Jersey, United States
Research Site — Albany, New York, United States
Research Site — New York, New York, United States
Research Site — Syracuse, New York, United States
Research Site — Columbus, Ohio, United States
Research Site — Springfield, Oregon, United States
Research Site — Hershey, Pennsylvania, United States
Research Site — Lancaster, Pennsylvania, United States
Research Site — Pittsburgh, Pennsylvania, United States
Research Site — Providence, Rhode Island, United States
Research Site — Myrtle Beach, South Carolina, United States
Research Site — Nashville, Tennessee, United States
Research Site — Austin, Texas, United States
Research Site — Austin, Texas, United States
Research Site — Houston, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — Spring, Texas, United States
Research Site — Salt Lake City, Utah, United States
Research Site — Norfolk, Virginia, United States
Research Site — Roanoke, Virginia, United States
Research Site — Virginia Beach, Virginia, United States
Research Site — Seattle, Washington, United States
Research Site — CABA, Argentina
Research Site — CABA, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Córdoba, Argentina
Research Site — Córdoba, Argentina
Research Site — Cuidad Autónoma de Buenos Aire, Argentina
Research Site — La Plata, Argentina
Research Site — Pergamino, Argentina
Research Site — Rosario, Argentina
Research Site — San Miguel de Tucumán, Argentina
Research Site — Viedma, Argentina
Research Site — Kingswood, Australia
Research Site — Murdoch, Australia
Research Site — Orange, Australia
Research Site — South Brisbane, Australia
Research Site — St Leonards, Australia
Research Site — Waratah, Australia
Research Site — Woolloongabba, Australia
Research Site — Graz, Austria
Research Site — Innsbruck, Austria
Research Site — Linz, Austria
Research Site — Vienna, Austria
Research Site — Vienna, Austria
Research Site — Brussels, Belgium
Research Site — Brussels, Belgium
Research Site — Ghent, Belgium
Research Site — Jette, Belgium
Research Site — Kortrijk, Belgium
Research Site — Leuven, Belgium
Research Site — Libramont-Chevigny, Belgium
Research Site — Roeselare, Belgium
Research Site — Wilrijk, Belgium
Research Site — Barretos, Brazil
Research Site — Cachoeiro de Itapemirim, Brazil
Research Site — Curitiba, Brazil
Research Site — Curitiba, Brazil
Research Site — Jaú, Brazil
Research Site — Londrina, Brazil
Research Site — Pelotas, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Recife, Brazil
Research Site — Rio de Janeiro, Brazil
Research Site — Rio de Janeiro, Brazil
Research Site — Salvador, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Calgary, Alberta, Canada
Research Site — Abbotsford British Columbia, British Columbia, Canada
Research Site — Vancouver, British Columbia, Canada
Research Site — Barrie, Ontario, Canada
Research Site — Brampton, Ontario, Canada
Research Site — London, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Chicoutimi, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Saskatoon, Saskatchewan, Canada
Research Site — Toronto, Canada
Research Site — Concepción, Chile
Research Site — La Serena, Chile
Research Site — Temuco, Chile
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Changchun, China
Research Site — Changsha, China
Research Site — Chongqing, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Jinan, China
Research Site — Jinhua, China
Research Site — Lanzhou, China
Research Site — Nanchang, China
Research Site — Ningbo, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shenyang, China
Research Site — Shenyang, China
Research Site — Sichuan, China
Research Site — Suining, China
Research Site — Tianjin, China
Research Site — Wuhan, China
Research Site — Wuhan, China
Research Site — Wuhu, China
Research Site — Xiamen, China
Research Site — Yangzhou, China
Research Site — Zhuhai, China
Research Site — Helsinki, Finland
Research Site — Helsinki, Finland
Research Site — Kuopio, Finland
Research Site — Oulu, Finland
Research Site — Tampere, Finland
Research Site — Turku, Finland
Research Site — Angers, France
Research Site — Bordeaux, France
Research Site — Caen, France
Research Site — Clermont-Ferrand, France
Research Site — Le Mans, France
Research Site — Marseille, France
Research Site — Montpellier, France
Research Site — Montpellier, France
Research Site — Nice, France
Research Site — Nîmes, France
Research Site — Paris, France
Research Site — Paris, France
Research Site — Paris, France
Research Site — Pierre-Bénite, France
Research Site — Rennes, France
Research Site — Saint-Herblain, France
Research Site — Saint-Priest-en-Jarez, France
Research Site — Strasbourg, France
Research Site — Suresnes, France
Research Site — Tours, France
Research Site — Vandœuvre-lès-Nancy, France
Research Site — Villejuif, France
Research Site — Augsburg, Germany
Research Site — Berlin, Germany
Research Site — Braunschweig, Germany
Research Site — Cologne, Germany
Research Site — Dresden, Germany
Research Site — Duisburg, Germany
Research Site — Düsseldorf, Germany
Research Site — Essen, Germany
Research Site — Giessen, Germany
Research Site — Göttingen, Germany
Research Site — Gronau, Germany
Research Site — Hamburg, Germany
Research Site — Herne, Germany
Research Site — Kiel, Germany
Research Site — Lübeck, Germany
Research Site — Marburg, Germany
Research Site — Münster, Germany
Research Site — Nuremberg, Germany
Research Site — Nürtingen, Germany
Research Site — Regensburg, Germany
Research Site — Schwerin, Germany
Research Site — Trier, Germany
Research Site — Ulm, Germany
Research Site — Würzburg, Germany
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Debrecen, Hungary
Research Site — Győr, Hungary
Research Site — Gyula, Hungary
Research Site — Zalaegerszeg, Hungary
Research Site — Ansārinagar, India
Research Site — Babgalore, India
Research Site — Calicut, India
Research Site — Delhi, India
Research Site — Hyderabad, India
Research Site — Kannur, India
Research Site — Kanpur, India
Research Site — Mumbai, India
Research Site — Nagpur, India
Research Site — Varanasi, India
Research Site — Afula, Israel
Research Site — Beersheba, Israel
Research Site — Hadera, Israel
Research Site — Haifa, Israel
Research Site — Jerusalem, Israel
Research Site — Jerusalem, Israel
Research Site — Kfar Saba, Israel
Research Site — Nahariya, Israel
Research Site — Petah Tikva, Israel
Research Site — Ramat Gan, Israel
Research Site — Tel Aviv, Israel
Research Site — Arezzo, Italy
Research Site — Bari, Italy
Research Site — Bergamo, Italy
Research Site — Bergamo, Italy
Research Site — Chieti, Italy
Research Site — Genoa, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Naples, Italy
Research Site — Palermo, Italy
Research Site — Pisa, Italy
Research Site — Roma, Italy
Research Site — Roma, Italy
Research Site — Rozzano, Italy
Research Site — Torino, Italy
Research Site — Varese, Italy
Research Site — Verona, Italy
Research Site — Bunkyō City, Japan
Research Site — Fukuoka, Japan
Research Site — Kamakura-shi, Japan
Research Site — Kawagoe-shi, Japan
Research Site — Kawasaki-shi, Japan
Research Site — Kisarazu-shi, Japan
Research Site — Kumamoto, Japan
Research Site — Kyoto, Japan
Research Site — Maebashi, Japan
Research Site — Miyazaki, Japan
Research Site — Ōta-ku, Japan
Research Site — Sagamihara-shi, Japan
Research Site — Shimotsuke-shi, Japan
Research Site — Yokohama, Japan
Research Site — Yokohama, Japan
Research Site — Batu Caves, Malaysia
Research Site — Kuala Lumpur, Malaysia
Research Site — Kuala Selangor, Malaysia
Research Site — Pulau Pinang, Malaysia
Research Site — Hilversum, Netherlands
Research Site — Hoofddorp, Netherlands
Research Site — Maastricht, Netherlands
Research Site — Nijmegen, Netherlands
Research Site — Roosendaal, Netherlands
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Trujillo, Peru
Research Site — Gdynia, Poland
Research Site — Gliwice, Poland
Research Site — Koszalin, Poland
Research Site — Krakow, Poland
Research Site — Piotrkow Trybunalski, Poland
Research Site — Poznan, Poland
Research Site — Rzeszów, Poland
Research Site — Warsaw, Poland
Research Site — Busan, South Korea
Research Site — Daegu, South Korea
Research Site — Goyang-si, South Korea
Research Site — Seongnam-si, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Girona, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Majadahonda, Spain
Research Site — Málaga, Spain
Research Site — Málaga, Spain
Research Site — Oviedo, Spain
Research Site — Sabadell, Spain
Research Site — Santander, Spain
Research Site — Valencia, Spain
Research Site — Valencia, Spain
Research Site — Gothenburg, Sweden
Research Site — Malmö, Sweden
Research Site — Stockholm, Sweden
Research Site — Stockholm, Sweden
Research Site — Umeå, Sweden
Research Site — Uppsala, Sweden
Research Site — Kaohsiung City, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taichung, Taiwan
Research Site — Tainan, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taoyuan, Taiwan
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Khon Kaen, Thailand
Research Site — Muang, Thailand
Research Site — Pathum Thani, Thailand
Research Site — Songkhla, Thailand
Research Site — Ankara, Turkey (Türkiye)
Research Site — Ankara, Turkey (Türkiye)
Research Site — Ankara, Turkey (Türkiye)
Research Site — Ankara, Turkey (Türkiye)
Research Site — Cordaleo, Turkey (Türkiye)
Research Site — Diyarbakır, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Izmir, Turkey (Türkiye)
Research Site — Sakarya, Turkey (Türkiye)
Research Site — Seyhan, Turkey (Türkiye)
Research Site — Şahinbey, Turkey (Türkiye)
Research Site — Aberdeen, United Kingdom
Research Site — Bristol, United Kingdom
Research Site — Cambridge, United Kingdom
Research Site — Edinburgh, United Kingdom
Research Site — Exeter, United Kingdom
Research Site — Glasgow, United Kingdom
Research Site — Greater London, United Kingdom
Research Site — Guildford, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — Manchester, United Kingdom
Research Site — Newcastle, United Kingdom
Research Site — Plymouth, United Kingdom
Research Site — Preston, United Kingdom
Research Site — Romford, United Kingdom

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