A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

Study Identifier:
D9723C00001
CT.gov Identifier:
NCT06120491
EudraCT Identifier:
2023-50424-30-00
EU Trial (CTIS) Number:
2023-504214-30-00
Study Contact Information:
N/A
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Study Summary

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

To evaluate the efficacy and safety of saruparib plus physician’s choice of ARPI (abiraterone, darolutamide, or enzalutamide) compared with placebo plus physician’s choice of ARPI in participants with mHSPC.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Male
    Age
    18 - 130 Years
    Study Drug
  • Drug: Experimental: Arm 1
    • Read More
  • Drug: Intervention/treatment
  • Drug: Drug: Abiraterone Acetate
  • Drug: Drug: Darolutamide
  • Drug: Drug: Enzalutamide
  • Drug: Placebo Comparator: Arm 2
  • Drug: Drug: Placebo
  • Drug: Experimental drug
  • Drug: Participants must be receiving androgen deprivation therapy throughout the study or have undergone bilateral orchiectomy, and must be suitable for treatment with NHAs.
  • Drug: ASCO GU 2025:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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
    • Key exclusion criteria include prior therapy with PARPi, prior chemotherapy or NHAs in the mCSPC setting (prior NHAs for localized disease permitted), and history of, or suspected, myelodysplastic syndrome/acute myeloid leukemia.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruiting
    Condition(s) Treated at Site
    Prostate