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 - EvoPAR-PR02

Study identifier:D9727C00001

ClinicalTrials.gov identifier:NCT06952803

EudraCT identifier:N/A

CTIS identifier:2024-513586-39

Will Be Recruiting

Official Title

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).

Medical condition

prostate cancer

Phase

Phase 3

Healthy volunteers

Study drug

Saruparib, Placebo, Abiraterone + Prednisolone/Prednisone, Androgen Deprivation Therapy (ADT)

Sex

Male

Estimated Enrollment

700

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 15 Jul 2025

Estimated Primary Completion Date: 31 Mar 2033

Estimated Study Completion Date: 30 Apr 2036

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2025 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion 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. 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

• 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.

No locations available

Arms	Assigned Interventions
Experimental: Cohort A: Saruparib (AZD5305) + Physician's Choice ADT Participants will receive saruparib along with ADT.	Drug: Saruparib Saruparib will be administered orally. Other Name: AZD5305 Drug: Androgen Deprivation Therapy (ADT) Standard of care ADT will be administered.
Placebo Comparator: Cohort A: Placebo + Physician's Choice ADT Participants will receive matching placebo to saruparib along with ADT.	Drug: Placebo Matching placebo to saruparib will be administered orally. Drug: Androgen Deprivation Therapy (ADT) Standard of care ADT will be administered.
Experimental: Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT.	Drug: Saruparib Saruparib will be administered orally. Other Name: AZD5305 Drug: Abiraterone + Prednisolone/Prednisone Abiraterone will be administered orally in combination with prednisone/prednisolone. Drug: Androgen Deprivation Therapy (ADT) Standard of care ADT will be administered.
Placebo Comparator: 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.	Drug: Placebo Matching placebo to saruparib will be administered orally. Drug: Abiraterone + Prednisolone/Prednisone Abiraterone will be administered orally in combination with prednisone/prednisolone. Drug: Androgen Deprivation Therapy (ADT) Standard of care ADT will be administered.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]