Recruiting
Phase 3

Saruparib & ARPI

Sponsor:

AstraZeneca

Code:

NCT07711002

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Saruparib

Placebo

Enzalutamide

Darolutamide

Abiraterone

Study Details

Brief summary:

The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Study ID

NCT07711002

Start date

Sep 15, 2026

Status verified date

Oct, 2026

Completion date

May 27, 2033

Anticipated

Primary completion date

May 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participant must be ≥ 18 at the time of signing the informed consent.
  • Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive.
  • Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC.
  • Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months.
  • Participants must have the following:

  • Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy.
  • Had no evidence of disease progression
  • Had all toxicities related to docetaxel- or Lu-PSMA-containing treatment (except for alopecia and peripheral neuropathy) resolved to CTCAE Grade 1 or lower.
  • PSA ≥ 0.2 ng/mL within 14 days prior to randomization.
  • Serum testosterone < 1.7 nmol/L or 50 ng/dL.
  • Palliative radiotherapy for symptoms management will be permitted and is to be completed at least 4 weeks prior to randomization for wide field radiation therapy and at least 2 weeks prior to randomization for limited field radiation therapy.
  • Provision of a FFPE tumor tissue sample and a blood sample (for ctDNA).
  • Confirmed HRRm, HRD and PTEN status.
  • Adequate organ and bone marrow function.
  • Minimum life expectancy of 6 months.
  • Male, assigned at birth, inclusive of all gender identities.
  • Contraceptive use by participants or participant partners should be consistent with local regulations.
  • Capable of giving signed informed consent.
  • \- -

Exclusion Criteria:

  • Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label.
  • Any history of persisting (> 2 weeks) severe cytopenia due to any cause (eg, ANC< 0.5 × 10\^9/L or platelets < 50 × 10\^9/L)
  • Any known predisposition to bleeding (eg, active peptic ulceration, recent \[within6 months\] hemorrhagic stroke, proliferative diabetic retinopathy.
  • Spinal cord compression or brain metastases unless asymptomatic and stable.
  • History of MDS/AML or with features suggestive of MDS/AML
  • History of another primary malignancy, with some exceptions.
  • Any chronic gastrointestinal diseases or conditions including inability to swallow the formulated product that would preclude adequate absorption of any study drug.
  • History of seizure or predispose to seizure, including any history of loss of consciousness or transient ischemic attack within 12 months of enrolment.
  • Serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
  • Major surgical procedure or significant traumatic injury within 4 weeks of the first dose or an anticipated need for major surgery during the study.
  • Switched ARPI agent in previous treatment for mHSPC due to disease progression. Note: if the ARPI agent was switched due to any reason other than disease progression and switch was prior to ICF signature, participants will be eligible.
  • Any prior treatment with a PARPi or platinum chemotherapy.
  • \- -

Study Design

Enrollment

1330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone

Saruparib 60 mg + ARPI (enzalutamide, darolutamide, or abiraterone) : Participants will receive saruparib 60 mg orally once daily in combination with physician's choice of ARPI in cycles of 28 days

placebo comparator: Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone

Placebo + ARPI (enzalutamide, darolutamide, or abiraterone): Participants will receive placebo orally once daily in combination with physician's choice of ARPI in cycles of 28 days

Interventions

Saruparib

Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)

Placebo

Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)

Enzalutamide

Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

Darolutamide

Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

Abiraterone

Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

Primary outcome measure

  • Radiographic progression-free survival (rPFS) [ Time Frame: Up to approximately 56 months ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Springdale, Arkansas, United States, 72762

Research Site

Recruiting

Margate, Florida, United States, 33063

Research Site

Recruiting

Miami, Florida, United States, 33165

Research Site

Recruiting

Montreal, Quebec, Canada, H2X 0A9

More Information

Sponsor

AstraZeneca

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • Saruparib
  • HRRm
  • non-HRRm
  • mHSPC
  • Prostate Cancer
  • AZD5305
  • PSA>0.2ng/ml
  • Androgen pathway modulation sensitive (APMS)
  • Castration sensitive
  • Metastatic prostate cancer
  • Hormone sensitive prostate cancer
  • PARPi
  • Docetaxel
  • PSMA-directed 177Lutetium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.