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Clinical Trials in India / NCT06120491
Active, not recruiting Phase 3

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

NCT06120491 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2023-11-21
Last updated
2026-07-29

Condition(s) studied

Metastatic Castration-Sensitive Prostate Cancer

Investigational drug(s) / intervention(s)

SaruparibPlaceboAbiraterone AcetateDarolutamideEnzalutamide

Saruparib: Oral

Placebo: Oral

Abiraterone Acetate: Oral

Darolutamide: Oral

Enzalutamide: Oral

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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 (as determined by prior diagnostic investigation). In case there is no clinical MDS/AML suspicion, no specific screening for MDS/AML (by BM/bone biopsy) is required. * 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 arrhythmia 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.

Primary outcome measure(s)

Trial sites (322)

FacilityCityRegionStatus
Research Site Chandler Arizona
Research Site Gilbert Arizona
Research Site Phoenix Arizona
Research Site Tucson Arizona
Research Site Little Rock Arkansas
Research Site Springdale Arkansas
Research Site Bakersfield California
Research Site Fountain Valley California
Research Site Fullerton California
Research Site Los Angeles California
Research Site Montebello California
Research Site San Francisco California
Research Site Santa Barbara California
Research Site Santa Monica California
Research Site Santa Rosa California
Research Site Golden Colorado
Research Site Lakewood Colorado
Research Site New Haven Connecticut
Research Site Atlanta Georgia
Research Site Glenview Illinois
Research Site Lake Barrington Illinois
Research Site Fort Wayne Indiana
Research Site Indianapolis Indiana
Research Site Westwood Kansas
Research Site Shreveport Louisiana
Research Site Scarborough Maine
Research Site Baltimore Maryland
Research Site Baltimore Maryland
Research Site Bethesda Maryland
Research Site Towson Maryland
Research Site Upper Marlboro Maryland
Research Site Grand Rapids Michigan
Research Site Troy Michigan
Research Site Rochester Minnesota
Research Site Bozeman Montana
Research Site Las Vegas Nevada
Research Site Las Vegas Nevada
Research Site Camden New Jersey
Research Site Albuquerque New Mexico
Research Site East Syracuse New York

+ 282 more sites — see the full list on the official registry below.

On this site

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More AstraZeneca trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06120491 on ClinicalTrials.gov ↗ ← All trials in India