RecruitingPhase 3NCT06120491
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
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)
Sponsor
AstraZeneca
Enrollment
1,800 participants
Start Date
Nov 21, 2023
Study Type
INTERVENTIONAL
Conditions
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: MALEMin Age: 18 YearsMax Age: 130 Years
Inclusion Criteria10
- 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 Criteria11
- 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.
Interventions
DRUGSaruparib
Oral
DRUGPlacebo
Oral
DRUGAbiraterone Acetate
Oral
DRUGDarolutamide
Oral
DRUGEnzalutamide
Oral
Locations(409)
View Full Details on ClinicalTrials.gov
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NCT06120491