Recruiting
Phase 3

Saruparib

Sponsor:

AstraZeneca

Code:

NCT06952803

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Saruparib

Placebo

Abiraterone + Prednisolone/Prednisone

Androgen Deprivation Therapy (ADT)

Study Details

Brief summary:

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).

Conditions

Prostate Cancer

Study ID

NCT06952803

Start date

Aug 6, 2025

Status verified date

Aug, 2026

Completion date

Apr 30, 2036

Anticipated

Primary completion date

Mar 31, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A: Saruparib (AZD5305) + Physician's Choice ADT

Participants will receive saruparib along with ADT.

placebo comparator: Cohort A: Placebo + Physician's Choice ADT

Participants will receive matching placebo to saruparib along with ADT.

experimental: Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)

Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT.

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.

Interventions

Saruparib

Saruparib will be administered orally.

Placebo

Matching placebo to saruparib will be administered orally.

Abiraterone + Prednisolone/Prednisone

Abiraterone will be administered orally in combination with prednisone/prednisolone.

Androgen Deprivation Therapy (ADT)

Standard of care ADT will be administered.

Primary outcome measure

  • Metastasis-free survival (MFS) [ Time Frame: Up to approximately 93 months ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Phoenix, Arizona, United States, 85054

Research Site

Recruiting

La Jolla, California, United States, 92037

Research Site

Recruiting

La Jolla, California, United States, 92093

Research Site

Recruiting

Los Angeles, California, United States, 90048

Research Site

Recruiting

San Diego, California, United States, 92123

Research Site

Recruiting

San Luis Obispo, California, United States, 93401

Research Site

Recruiting

Lakewood, Colorado, United States, 80215

Research Site

Recruiting

Hialeah, Florida, United States, 33016

Research Site

Recruiting

Jacksonville, Florida, United States, 32224

Research Site

Recruiting

Tampa, Florida, United States, 33612

Research Site

Recruiting

Newnan, Georgia, United States, 30265

Research Site

Recruiting

Chicago, Illinois, United States, 60611

Research Site

Recruiting

Chicago Ridge, Illinois, United States, 60415

Research Site

Recruiting

Greenwood, Indiana, United States, 46143

Research Site

Recruiting

Towson, Maryland, United States, 21204

Research Site

Recruiting

Plymouth, Massachusetts, United States, 02360

Research Site

Recruiting

Rochester, Minnesota, United States, 55905

Research Site

Recruiting

Hackensack, New Jersey, United States, 07601

Research Site

Recruiting

Voorhees Township, New Jersey, United States, 08043

Research Site

Recruiting

New York, New York, United States, 10065

Research Site

Recruiting

Syracuse, New York, United States, 13210

Research Site

Recruiting

Columbus, Ohio, United States, 43230

Research Site

Recruiting

Springfield, Oregon, United States, 97477

Research Site

Recruiting

Hershey, Pennsylvania, United States, 17033

Research Site

Recruiting

Lancaster, Pennsylvania, United States, 17601

Research Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Research Site

Recruiting

Providence, Rhode Island, United States, 02903

Research Site

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Research Site

Recruiting

Nashville, Tennessee, United States, 37209

Research Site

Recruiting

Austin, Texas, United States, 78705

Research Site

Recruiting

Austin, Texas, United States, 78745

Research Site

Recruiting

Houston, Texas, United States, 77074

Research Site

Recruiting

San Antonio, Texas, United States, 78229

Research Site

Recruiting

Spring, Texas, United States, 77380

Research Site

Recruiting

Norfolk, Virginia, United States, 23502

Research Site

Recruiting

Roanoke, Virginia, United States, 24014

Research Site

Recruiting

Virginia Beach, Virginia, United States, 23462

More Information

Sponsor

AstraZeneca

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Localised/locally advanced prostate cancer
  • High-risk biochemical recurrence (BCR)
  • Poly (ADP-ribose) polymerase
  • Radiation therapy or radiotherapy
  • Breast cancer gene (BRCA) mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-21.