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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06952803
Registration number
NCT06952803
Ethics application status
Date submitted
30/04/2025
Date registered
1/05/2025
Date last updated
11/07/2025
Titles & IDs
Public title
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
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Scientific title
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).
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Secondary ID [1]
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2024-513586-39
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Secondary ID [2]
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D9727C00001
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Universal Trial Number (UTN)
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Trial acronym
EvoPAR-PR02
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Saruparib
Treatment: Drugs - Placebo
Treatment: Drugs - Abiraterone + Prednisolone/Prednisone
Treatment: Drugs - Androgen Deprivation Therapy (ADT)
Experimental: Cohort A: Saruparib (AZD5305) + Physician's Choice ADT - Participants will receive saruparib along with ADT.
Placebo comparator: Cohort A: Placebo + Physician's Choice ADT - Participants will receive matching placebo to saruparib along with ADT.
Experimental: Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) - Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT.
Placebo comparator: Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) - Participants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT.
Treatment: Drugs: Saruparib
Saruparib will be administered orally.
Treatment: Drugs: Placebo
Matching placebo to saruparib will be administered orally.
Treatment: Drugs: Abiraterone + Prednisolone/Prednisone
Abiraterone will be administered orally in combination with prednisone/prednisolone.
Treatment: Drugs: Androgen Deprivation Therapy (ADT)
Standard of care ADT will be administered.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Metastasis-free survival (MFS)
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Assessment method [1]
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MFS is defined as the time from randomisation until the date of first appearance of distant metastases, confirmed by standard clinical imaging \[computed tomography (CT)/ magnetic resonance imaging (MRI) and bone scan, or prostate-specific membrane antigen-positron emission tomography (PSMA-PET)\], as assessed by blinded independent central review (BICR) or death due to any cause.
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Timepoint [1]
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Up to approximately 93 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomisation until the date of death due to any cause.
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Timepoint [1]
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Up to approximately 11 years
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Secondary outcome [2]
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MFS (CT/MRI and bone scan)
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Assessment method [2]
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MFS is defined as the time from randomisation until the date of distant metastases, confirmed by conventional imaging (CT/MRI and bone scan), or death due to any cause.
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Timepoint [2]
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Up to approximately 93 months
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Secondary outcome [3]
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MFS (PSMA-PET)
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Assessment method [3]
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MFS is defined as the time from randomisation until the date of distant metastases, confirmed by PSMA-PET imaging or death due to any cause.
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Timepoint [3]
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0
Up to approximately 93 months
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Secondary outcome [4]
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MFS (standard clinical imaging)
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Assessment method [4]
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MFS is defined as the time from randomisation until the date of distant metastases, confirmed by standard clinical imaging (CT/MRI and bone scan or PSMA-PET), histology, or death due to any cause.
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Timepoint [4]
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Up to approximately 93 months
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Secondary outcome [5]
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Time from randomisation to Progression Free Survival 2 (PFS2)
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Assessment method [5]
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Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression \[defined as radiographic progression, clinical progression, or prostate-specific antigen (PSA) progression\] after initiation of first subsequent systemic treatment following the initial investigator-assessed progression or death. The date of second progression will be investigator assessed according to local standard clinical practice.
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Timepoint [5]
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Up to approximately 93 months
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Secondary outcome [6]
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Time to PSA progression
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Assessment method [6]
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Time to PSA progression is defined as the time from randomisation to PSA progression per Phoenix criteria.
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Timepoint [6]
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Up to approximately 93 months
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Secondary outcome [7]
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Prostate cancer-specific survival (PCSS)
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Assessment method [7]
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PCSS is defined as the time from randomisation until the date of death due to the underlying prostate cancer.
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Timepoint [7]
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Up to approximately 11 years
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Secondary outcome [8]
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Time to deterioration in urinary symptoms (TTDUS)
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Assessment method [8]
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TTDUS is defined as the time from randomisation to deterioration in EORTC-QLQ-PR25 (US) subscale scores.
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Timepoint [8]
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Up to approximately 93 months
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Secondary outcome [9]
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Time to deterioration in physical function (TTDPF)
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Assessment method [9]
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TTDPF is defined as the time from randomisation to deterioration in EORTC-QLQ-C30 Physical Function subscale scores.
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Timepoint [9]
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Up to approximately 93 months
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Secondary outcome [10]
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Plasma concentrations of saruparib
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Assessment method [10]
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To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).
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Timepoint [10]
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Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
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Secondary outcome [11]
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Area under the curve (AUC)
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Assessment method [11]
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To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).
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Timepoint [11]
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Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
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Secondary outcome [12]
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Maximum observed concentration (Cmax)
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Assessment method [12]
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To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).
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Timepoint [12]
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Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
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Secondary outcome [13]
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Time to Cmax (Tmax)
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Assessment method [13]
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To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).
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Timepoint [13]
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Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
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Secondary outcome [14]
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Number of participants with adverse events (AEs)
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Assessment method [14]
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To assess the safety and tolerability of saruparib administered in combination with ADT alone (Cohort A) and in combination with ADT + abiraterone (Cohort B).
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Timepoint [14]
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Up to approximately 11 years
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Eligibility
Key inclusion criteria
* Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
* Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.
* Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
* Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.
* Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
* Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.
* Minimum life expectancy of 12 months.
* Adequate organ and bone marrow function as described in study protocol.
* All participants will have received either primary or salvage RT. Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent. Use of metastases-directed therapy, as part of the RT radiation plan, is permitted as localized RT treatment for a metastatic lesion(s) outside the pelvis.
* All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.
* Participants must not father children or donate sperm from signing informed consent form (ICF), during the study intervention and for 6 months after the last dose of study intervention.
* Participants must use a condom (with spermicide - where permitted) from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
* Participants with any known predisposition to bleeding [e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy].
* Any history of persisting (> 2 weeks) severe cytopenia due to any cause.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and/or abiraterone.
* History of another primary malignancy, with exceptions.
* Persistent toxicities [Common Terminology Criteria for Adverse Events (CTCAE) Grade = 2] caused by previous anticancer therapy.
* Cardiac criteria, including history of arrhythmia and cardiovascular disease.
* Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
* Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
* Active tuberculosis infection.
* Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.
* Prior treatment within 14 days with blood product support or growth factor support.
* Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib and abiraterone) or herbal supplements within 21 days or at least 5 half-lives (whichever is longer), of randomization.
* Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).
* Participants with a known hypersensitivity to saruparib or any excipients of these products.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
15/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2036
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Actual
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Sample size
Target
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Kingswood
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Recruitment hospital [2]
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Research Site - St Leonards
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Georgia
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Indiana
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New Jersey
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Pennsylvania
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South Carolina
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Washington
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Austria
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Graz
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Austria
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Innsbruck
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Vienna
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Roeselare
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Malaysia
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Batu Caves
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Malaysia
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Kuala Lumpur
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Malaysia
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Pulau Pinang
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Malaysia
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Selangor
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Netherlands
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Roosendaal
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Peru
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Lima
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Poland
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Poland
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Poland
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Koszalin
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Poland
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Krakow
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Poland
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Piotrków Trybunalski
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Madrid
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Sabadell
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Spain
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Santander
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Spain
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Valencia
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Sweden
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Stockholm
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taoyuan
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Thailand
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Khon Kaen
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Thailand
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Muang
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Thailand
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Songkhla
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Karsiyaka
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Turkey
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Sahinbey
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United Kingdom
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Bristol
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United Kingdom
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Edinburgh
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Parexel
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Ethics approval
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Summary
Brief summary
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).
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Trial website
https://clinicaltrials.gov/study/NCT06952803
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Contacts
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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Phone
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1-877-240-9479
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06952803
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