Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

• Status: Recruiting
• Trial end date: 2031-04-30
• Target enrollment: 0
• Participant gender: Male

Summary

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Abiraterone Acetate

Criteria

Inclusion Criteria:

• Male ≥ 18 years of age

• Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.

• Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.

• Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and < 4 months prior to randomisation

• ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.

• Provision of FFPE tumour tissue sample and blood sample (for ctDNA)

• Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to

determine cohort eligibility

• Adequate organ and bone marrow function as described in study protocol

• Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.

• Participants must use a condom 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 MDS/AML or with features suggestive of MDS/AML

• Participants with any known predisposition to bleeding

• Any history of persisting (> 2 weeks) severe cytopenia

• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.

• History of another primary malignancy, with exceptions

• Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.

• Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention

• Cardiac criteria, including history of arrythmia and cardiovascular disease

• Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions:

• Prior treatment within 14 days with blood product support or growth factor support.

• Participants who are unevaluable for both bone and soft tissue progression