A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (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:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruitment Complete
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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.
Evaluate the efficacy and safety of AZD5305 combined with NHA versus placebo versus NHA. Includes evaluations of the following endpoints: That is, imaging-free progression-free survival, second progression-free survival, asymptomatic skeletal event survival, time to first occurrence of castration-resistant event, time to pain progression, time to worsening urinary symptoms, time to fatigue worsening, time to physical function deterioration, time to first follow-up treatment or death, overall survival, and evaluation of efficacy and safety.
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.
Phase III
Sex
Male
Age
18 - 130 Years
Study Drug
Drug: serial numbernameusage 1Chinese common name: NA English common name: Saruparib Trade name: NADosage form: Tablet Specification: 20mg*30 tablets/bottle Dosage and dosage: 60mg, once a day, oral administration duration: continue to take the medication until imaging is assessed by the investigator based on RECIST 1.1 (soft tissue lesions) and/or PCWG3 (bone lesions) clinical progression, occurrence of unacceptable toxicity, or withdrawal of informed consent by subjects. control drug serial numbernameusage 1Chinese common name: placebo Dosage form: Tablet Specification: 20mg*30 tablets/bottle Dosage and dosage: 60mg, once a day, oral administration duration: continue to take the medication until imaging is assessed by the investigator based on RECIST 1.1 (soft tissue lesions) and/or PCWG3 (bone lesions) clinical progression, occurrence of unacceptable toxicity, or withdrawal of informed consent by subjects. Participants must be receiving androgen deprivation therapy throughout the study or have undergone bilateral orchiectomy, and must be suitable for treatment with NHAs. Participants are allocated to either the HRRm or non-HRRm cohort based on prospective testing of both tumor tissue and circulating tumor DNA. Participants are randomized 1:1 to receive saruparib plus physician’s choice of NHA or placebo plus physician’s choice of NHA. ASCO GU 2025: Participants are randomized 1:1 to receive saruparib plus physician’s choice of ARPI or placebo plus physician’s choice of ARPI. Treatment continues until disease progression, unacceptable toxicity, or participant-initiated withdrawal. Participants must be receiving androgen deprivation therapy throughout the study or have undergone bilateral orchiectomy, and must be suitable for treatment with ARPIs.
Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete
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 (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.
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
Recruitment Complete
Condition(s) Treated at Site
Prostate