Prostate Cancer
Conditions
Interventions
Experimental: Saruparib (AZD5305) + Physician's Choice ADT
Participants will receive saruparib along with ADT.
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 Years and older (Adult, Older Adult ) - 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. - Adequate organ and bone marrow function as described in study protocol. - All participants will have received either primary or salvage RT. 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 localized 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
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 or more] 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metastasis-free survival (MFS) 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. | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Finland, France, Germany, Hungary, India, Italy, Japan, Koesa, Republic of, Netherland, Peru, Poland, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed