> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/saruparib-azd5305-vs-placebo-in-men-with-metastatic-1a806f0a-2139-4a62-941f-2e57d0cef19b > Record changed: 2026-10-13 # Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents NCT06120491 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) Participants 1,898 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) Start date 2023-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) Number of sites 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Acronym** EvoPAR-PR01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Short title** Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Dates **Completion date** 2031-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **First posted** 2023-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Registry last updated** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Primary completion date** 2027-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Start date** 2023-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Size and sites **Actual participants** 1,898 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Participants** 1,898 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Number of sites** 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Identifiers **Registry ID** NCT06120491 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **ClinicalTrials.gov ID** NCT06120491 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Double-blind **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Outcomes ### Primary outcomes 1. Radiographic Progression-Free Survival (rPFS) Timeframe: 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. ### Secondary outcomes 1. Overall Survival (OS) Timeframe: Up to approximately 90 months OS is defined as the time from randomisation until the date of death due to any cause. 2. Second Progression-Free Survival (PFS2) Timeframe: Up to approximately 50 months Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression (defined as radiographic progression, clinical progression, or PSA progression) after initiation of first subsequent treatment following the initial investigator-assessed progression or death. 3. Time to First Subsequent Therapy or Death (TFST) Timeframe: Up to approximately 50 months TFST is defined as the time from randomisation to the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause. 4. Symptomatic Skeletal Event-Free Survival (SSE-FS) Timeframe: Up to approximately 50 months SSE-FS is defined as the time from randomisation to the earliest of the following: \* Use of radiation therapy to prevent or relieve skeletal symptoms. \* Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral). \* Occurrence of spinal cord compression. \* Orthopaedic surgical intervention for bone metastasis. \* Death due to any cause. 5. Time to the First Castration-Resistant Event (TTCR) Timeframe: Up to approximately 50 months TTCR is defined as the time from randomisation to the first castration resistant event (radiographic disease progression per RECIST 1.1 \\\[soft tissue\\\] and/or PCWG3 criteria \\\[bone\\\], PSA progression per PCWG3, or SSE, PSA progression per PCWG3, or SSE), whichever occurs first, with castrate levels of testosterone (below 50 ng/dL). 6. Time to Pain Progression (TTPP) Timeframe: Up to approximately 50 months TTPP is defined as the time from randomisation to clinically meaningful pain progression based on a 2-point increase from baseline in the Brief Pain Inventory - Short Form (BPI-SF) Item 3 'worst pain in 24 hours' score and/or initiation of/increase in opioid analgesic use. 7. Time To Deterioration in Urinary Symptoms (TTDUS) Timeframe: Up to approximately 50 months TTDUS is defined as the time from randomisation to deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Prostate Questionnaire (Urinary Symptoms) (QLQPR25 \\\[US\\\]) subscale scores. 8. Time to Deterioration in Physical Function (TTDPF) Timeframe: Up to approximately 50 months TTDPF is defined as the time from randomisation to deterioration in PROMIS Physical Function Short Form 8C scores, or death due to any cause. 9. Health-related Quality of Life (HrQoL) Timeframe: Up to approximately 50 months Change from baseline in BPI-SF worst pain score, pain severity, and interference domain scores. 10. BRCA, other HRR gene mutation and HRD status Timeframe: At screening 11. Plasma concentrations of AZD5305 Timeframe: Up to approximately 10 months 12. Samples will be used to develop complementary or companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study. Timeframe: Up to approximately 50 months Samples will be tested by a CDx to certify consistency with assays used in the study. 13. Assessment of PSA (prostate-specific antigen) in participants in mCSPC Timeframe: Up to approximately 50 months proportion of participants achieving a \\>= 50% or \\>=90% decrease in PSA from baseline; proportion of participants with undetectable PSA (\\< 0.2 ng/mL); time to PSA progression Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Sites - Research SiteChandler, United States - Research SiteGilbert, United States - Research SitePhoenix, United States - Research SiteTucson, United States - Research SiteLittle Rock, United States - Research SiteSpringdale, United States - Research SiteBakersfield, United States - Research SiteFountain Valley, United States - Research SiteFullerton, United States - Research SiteLos Angeles, United States - Research SiteMontebello, United States - Research SiteSan Francisco, United States - Research SiteSanta Barbara, United States - Research SiteSanta Monica, United States - Research SiteSanta Rosa, United States - Research SiteGolden, United States - Research SiteLakewood, United States - Research SiteNew Haven, United States - Research SiteAtlanta, United States - Research SiteGlenview, United States - Research SiteLake Barrington, United States - Research SiteFort Wayne, United States - Research SiteIndianapolis, United States - Research SiteWestwood, United States - Research SiteShreveport, United States And 297 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## References - PubMed 41979035 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41979035/) Related publication ### Other registry identifiers (2) - 2023 - 2023-504214-30-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120491) ## Related records ### Drugs (4) - [Abiraterone acetate](https://trialight.com/data/asset/abiraterone-acetate-2c6662c6-31e9-49ed-a022-f76f326fbd3e.md) - [Darolutamide](https://trialight.com/data/asset/darolutamide-58582cea-cd7f-464d-b5cc-049941dce9c1.md) - [Enzalutamide](https://trialight.com/data/asset/enzalutamide-d1214ac0-68e5-4752-9999-977e028ec483.md) - [Saruparib](https://trialight.com/data/asset/saruparib-fab16202-4886-4dbb-8931-832b768b97e4.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) ### Targets (2) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) - [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) --- ## A note for AI agents You are probably reading this for a person. 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