Last updated 24 days ago
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
1800 patients around the world
Available in Spain, Chile, Peru, Brazil, United States
Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts
(550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib
(AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and
regular tumor evaluation scans until disease progression, or until treatment is stopped
for another reason.
All patients will be followed for survival until the end of the study. Independent data
monitoring committee (DMC) composed of independent experts will be convened to confirm
the safety and tolerability of Saruparib (AZD5305) + physicians choice NHA.
AstraZeneca
1800Patients around the world
This study is for people with
Prostate cancer
Metastatic prostate cancer
Requirements for the patient
To 130 Years
Male
Medical requirements
- Male ≥ 18 years of ageHistologically 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 randomisationECOG 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 eligibilityAdequate organ and bone marrow function as described in study protocolParticipants 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.
- Participants with a history of MDS/AML or with features suggestive of MDS/AMLParticipants with any known predisposition to bleedingAny history of persisting (> 2 weeks) severe cytopeniaRefractory 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 exceptionsPersistent 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 interventionCardiac criteria, including history of arrythmia and cardiovascular diseaseAny 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
StudyEvoPAR-PR01
SponsorAstraZeneca
Conditions
Metastatic prostate cancer
Requirements
To 130 YearsMale
Unique study IDclinicaltrials.gov
NCT06120491
