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)
Radiographic Progression-Free Survival (rPFS) — Up to approximately 50 months rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.
Trial sites (322)
Facility
City
Region
Status
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.
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.
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