Trial Review

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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
30/05/2025

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
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).
Secondary ID [1] 0 0
2024-513586-39
Secondary ID [2] 0 0
D9727C00001
Universal Trial Number (UTN)
Trial acronym
EvoPAR-PR02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Metastasis-free survival (MFS)
Timepoint [1] 0 0
Up to approximately 93 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 11 years
Secondary outcome [2] 0 0
MFS (CT/MRI and bone scan)
Timepoint [2] 0 0
Up to approximately 93 months
Secondary outcome [3] 0 0
MFS (PSMA-PET)
Timepoint [3] 0 0
Up to approximately 93 months
Secondary outcome [4] 0 0
MFS (standard clinical imaging)
Timepoint [4] 0 0
Up to approximately 93 months
Secondary outcome [5] 0 0
Time from randomisation to Progression Free Survival 2 (PFS2)
Timepoint [5] 0 0
Up to approximately 93 months
Secondary outcome [6] 0 0
Time to PSA progression
Timepoint [6] 0 0
Up to approximately 93 months
Secondary outcome [7] 0 0
Prostate cancer-specific survival (PCSS)
Timepoint [7] 0 0
Up to approximately 11 years
Secondary outcome [8] 0 0
Time to deterioration in urinary symptoms (TTDUS)
Timepoint [8] 0 0
Up to approximately 93 months
Secondary outcome [9] 0 0
Time to deterioration in physical function (TTDPF)
Timepoint [9] 0 0
Up to approximately 93 months
Secondary outcome [10] 0 0
Plasma concentrations of saruparib
Timepoint [10] 0 0
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Secondary outcome [11] 0 0
Area under the curve (AUC)
Timepoint [11] 0 0
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Secondary outcome [12] 0 0
Maximum observed concentration (Cmax)
Timepoint [12] 0 0
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Secondary outcome [13] 0 0
Time to Cmax (Tmax)
Timepoint [13] 0 0
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Secondary outcome [14] 0 0
Number of participants with adverse events (AEs)
Timepoint [14] 0 0
Up to approximately 11 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2036
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Kingswood
Recruitment hospital [2] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Innsbruck
Country [13] 0 0
Austria
State/province [13] 0 0
Vienna
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles
Country [15] 0 0
Belgium
State/province [15] 0 0
Kortrijk
Country [16] 0 0
Belgium
State/province [16] 0 0
Roeselare
Country [17] 0 0
Belgium
State/province [17] 0 0
Wilrijk
Country [18] 0 0
Brazil
State/province [18] 0 0
Curitiba
Country [19] 0 0
Brazil
State/province [19] 0 0
Londrina
Country [20] 0 0
Brazil
State/province [20] 0 0
Pelotas
Country [21] 0 0
Brazil
State/province [21] 0 0
Porto Alegre
Country [22] 0 0
Brazil
State/province [22] 0 0
Salvador
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Paulo
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Toronto
Country [26] 0 0
Chile
State/province [26] 0 0
Temuco
Country [27] 0 0
China
State/province [27] 0 0
Hangzhou
Country [28] 0 0
China
State/province [28] 0 0
Ningbo
Country [29] 0 0
China
State/province [29] 0 0
Sichuan
Country [30] 0 0
China
State/province [30] 0 0
Xiamen
Country [31] 0 0
Finland
State/province [31] 0 0
Tampere
Country [32] 0 0
France
State/province [32] 0 0
Angers
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux Cedex
Country [34] 0 0
France
State/province [34] 0 0
Clermont Ferrand
Country [35] 0 0
France
State/province [35] 0 0
Le Mans
Country [36] 0 0
France
State/province [36] 0 0
Marseille
Country [37] 0 0
France
State/province [37] 0 0
Montpellier
Country [38] 0 0
France
State/province [38] 0 0
Nice
Country [39] 0 0
France
State/province [39] 0 0
Nîmes
Country [40] 0 0
France
State/province [40] 0 0
Pierre-Benite
Country [41] 0 0
France
State/province [41] 0 0
Suresnes Cedex
Country [42] 0 0
France
State/province [42] 0 0
Vandoeuvre-lès-nancy
Country [43] 0 0
France
State/province [43] 0 0
Villejuif
Country [44] 0 0
Germany
State/province [44] 0 0
Braunschweig
Country [45] 0 0
Germany
State/province [45] 0 0
Dresden
Country [46] 0 0
Germany
State/province [46] 0 0
Duisburg
Country [47] 0 0
Germany
State/province [47] 0 0
Essen
Country [48] 0 0
Germany
State/province [48] 0 0
Giessen
Country [49] 0 0
Germany
State/province [49] 0 0
Goettingen
Country [50] 0 0
Germany
State/province [50] 0 0
Hamburg
Country [51] 0 0
Germany
State/province [51] 0 0
Herne
Country [52] 0 0
Germany
State/province [52] 0 0
Marburg
Country [53] 0 0
Germany
State/province [53] 0 0
Nürnberg
Country [54] 0 0
Germany
State/province [54] 0 0
Nürtingen
Country [55] 0 0
Germany
State/province [55] 0 0
Regensburg
Country [56] 0 0
Germany
State/province [56] 0 0
Ulm
Country [57] 0 0
Germany
State/province [57] 0 0
Würzburg
Country [58] 0 0
Hungary
State/province [58] 0 0
Budapest
Country [59] 0 0
Hungary
State/province [59] 0 0
Debrecen
Country [60] 0 0
India
State/province [60] 0 0
Ansari Nagar
Country [61] 0 0
India
State/province [61] 0 0
Delhi
Country [62] 0 0
India
State/province [62] 0 0
Nagpur
Country [63] 0 0
Italy
State/province [63] 0 0
Genoa
Country [64] 0 0
Italy
State/province [64] 0 0
Milano
Country [65] 0 0
Italy
State/province [65] 0 0
Napoli
Country [66] 0 0
Italy
State/province [66] 0 0
Roma
Country [67] 0 0
Italy
State/province [67] 0 0
Rozzano
Country [68] 0 0
Italy
State/province [68] 0 0
Verona
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Busan
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Daegu
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Goyang-si
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Seoul
Country [73] 0 0
Malaysia
State/province [73] 0 0
Batu Caves
Country [74] 0 0
Malaysia
State/province [74] 0 0
Kuala Lumpur
Country [75] 0 0
Malaysia
State/province [75] 0 0
Pulau Pinang
Country [76] 0 0
Peru
State/province [76] 0 0
Lima
Country [77] 0 0
Poland
State/province [77] 0 0
Gdynia
Country [78] 0 0
Poland
State/province [78] 0 0
Gliwice
Country [79] 0 0
Poland
State/province [79] 0 0
Koszalin
Country [80] 0 0
Poland
State/province [80] 0 0
Krakow
Country [81] 0 0
Poland
State/province [81] 0 0
Piotrków Trybunalski
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
Girona
Country [84] 0 0
Spain
State/province [84] 0 0
Madrid
Country [85] 0 0
Spain
State/province [85] 0 0
Málaga
Country [86] 0 0
Spain
State/province [86] 0 0
Sabadell
Country [87] 0 0
Spain
State/province [87] 0 0
Santander
Country [88] 0 0
Spain
State/province [88] 0 0
Valencia
Country [89] 0 0
Sweden
State/province [89] 0 0
Stockholm
Country [90] 0 0
Taiwan
State/province [90] 0 0
Kaohsiung
Country [91] 0 0
Taiwan
State/province [91] 0 0
Tainan
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taoyuan
Country [93] 0 0
Thailand
State/province [93] 0 0
Khon Kaen
Country [94] 0 0
Thailand
State/province [94] 0 0
Muang
Country [95] 0 0
Thailand
State/province [95] 0 0
Songkhla
Country [96] 0 0
Turkey
State/province [96] 0 0
Ankara
Country [97] 0 0
Turkey
State/province [97] 0 0
Istanbul
Country [98] 0 0
Turkey
State/province [98] 0 0
Karsiyaka

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
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