ClinicaliQ Trial Snapshot
- Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician’s Choice New Hormonal Agents — Recruiting • Phase III • Oncology • NCT06120491.
- 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.
- Sponsor: AstraZeneca.
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What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.