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A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Prostate Cancer
Date of first enrollment	30/09/2025
Target sample size	40
Countries of recruitment	United States,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Finland,Japan,France,Japan,Germany,Japan,Hungary,Japan,India,Japan,Italy,Japan,Koesa, Republic of,Japan,Netherland,Japan,Peru,Japan,Poland,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan
Study type	Interventional
Intervention(s)	Experimental: Saruparib (AZD5305) + Physician's Choice ADT Participants will receive saruparib along with ADT.

Outcome(s)

Primary Outcome

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.

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.