ClinicalTrials.Veeva

Menu

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)

AstraZeneca logo

AstraZeneca

Status and phase

Begins enrollment this month
Phase 3

Conditions

Prostate Cancer

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT06952803
D9727C00001
2024-513586-39 (Other Identifier)

Details and patient eligibility

About

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).

Full description

Approximately, 700 adult participants with localized/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 (localized/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).

Enrollment

700 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

700 participants in 4 patient groups, including a placebo group

Cohort A: Saruparib (AZD5305) + Physician's Choice ADT
Experimental group
Description:
Participants will receive saruparib along with ADT.
Treatment:
Drug: Androgen Deprivation Therapy (ADT)
Drug: Saruparib
Cohort A: Placebo + Physician's Choice ADT
Placebo Comparator group
Description:
Participants will receive matching placebo to saruparib along with ADT.
Treatment:
Drug: Androgen Deprivation Therapy (ADT)
Drug: Placebo
Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
Experimental group
Description:
Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT.
Treatment:
Drug: Androgen Deprivation Therapy (ADT)
Drug: Abiraterone + Prednisolone/Prednisone
Drug: Saruparib
Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
Placebo Comparator group
Description:
Participants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT.
Treatment:
Drug: Androgen Deprivation Therapy (ADT)
Drug: Placebo
Drug: Abiraterone + Prednisolone/Prednisone

Trial contacts and locations

25

Loading...

Central trial contact

AstraZeneca Clinical Study Information Center

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems