CTRI/2025/10/096699 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On:
30/10/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
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 (EvoPAR-PR02)
Scientific Title of Study
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)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
2024-513586-39
Other
D9727C00001, Version 2.0, dated: 10-Apr-2025
Protocol Number
NCT06952803
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Annappa Kamath
Designation
Executive Director Project Leadership
Affiliation
Parexel International Clinical Research Private Limited
Address
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Bangalore KARNATAKA 560103 India
Phone
919902096914
Fax
918067723001
Email
Annappa.Kamath@parexel.com
Details of Contact Person Scientific Query
Name
Dr Annappa Kamath
Designation
Executive Director Project Leadership
Affiliation
Parexel International Clinical Research Private Limited
Address
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
KARNATAKA 560103 India
Phone
919902096914
Fax
918067723001
Email
Annappa.Kamath@parexel.com
Details of Contact Person Public Query
Name
Dr Annappa Kamath
Designation
Executive Director Project Leadership
Affiliation
Parexel International Clinical Research Private Limited
Address
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
KARNATAKA 560103 India
Phone
919902096914
Fax
918067723001
Email
Annappa.Kamath@parexel.com
Source of Monetary or Material Support
AstraZeneca AB, 151 85 Södertälje, Sweden
Primary Sponsor
Name
AstraZeneca AB
Address
151 85 Södertälje, Sweden
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Parexel International Clinical Research Private Limited
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Countries of Recruitment
Argentina Australia Austria Belgium Brazil China Finland France Germany Hungary India Israel Italy Japan Netherlands Poland Republic of Korea Spain Sweden Taiwan Thailand Turkey United Kingdom United States of America
Sites of Study
No of Sites = 8
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Atul Batra
All India Institute of Medical Science
Room no 102, Department of Medical Oncology, Division of Medical Sciences DR. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar East, AIIMS Campus New Delhi, Delhi – 110029 South West DELHI
9013078407
batraatul85@gmail.com
Dr K Krishnamani
American Oncology Institute, Citizens Specialty hospital
Department of clinical research 1-100/1/CCH, Nallagandla
Village, Seriligampally
Mandal, Hyderabad-
500019, Telangana, India.
Hyderabad TELANGANA
Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Diagnostic and treatment NT (DNT) BLOCK 1ST Floor, Clinical research secretariat department OPD 22 , Ground Floor, D&T Block,Mahamana
Pandit Madan Mohan
Malaviya Cancer Centre,
Sundar Bagiya, Near
Nariya Gate, Banaras
Hindu University Campus,
Varanasi, Uttar
Pradesh,221005, India Varanasi UTTAR PRADESH
0542-6917700
bkmmishra@gmail.com
Dr Praveen Kumar Shenoy V P
Malabar Cancer Centre
3rd floor, Department of Clinical Hematology and Medical Oncology Malabar Cancer Centre-(PGIOSR) Thalassery, Moozhikkara
PO, Kannur, Kerala, India,
670103 Kannur KERALA
4902399250
vppraveen233@gmail.com
Dr Vikas T Talreja
Regency Hospital Ltd
1st floor, Regency Hospital Ltd Tower 2 cancer & Gastro
care Sarvodaya Nagar,
Kanpur 208005, Uttar Pradesh, India. Kanpur Nagar UTTAR PRADESH
9769890961
vikasttalreja@gmail.com
Dr Satheesh C T
Spandana Oncology Centre
Department of Medical Oncology No. 919, New No 68,28th
Main Road,9th Block,
Jayanagar, Bangalore -
560069 Bangalore KARNATAKA
9242698750
drsatheeshct@gmail.com
Dr Nandini Menon
Tata Memorial Hospital
Room No: 202, 2nd floor,
Homi Bhabha Block
Building, Department of Medical oncology, Tata Memorial Hospital, Dr E. Borges
Marg, Parel (East), Mumbai
400012, Maharashtra, India
Mumbai MAHARASHTRA
9769178270
nandini.menon1412@gmail.com
Details of Ethics Committee
No of Ethics Committees= 8
Name of Committee
Approval Status
All India Institute of Medical Sciences Old OT Block, Room No 102, AIIMS Hospital Ansari Nagar, New Delhi 110029, India
IEC Malabar Cancer Centre Malabar Cancer Centre Moozhikkara P.O Kodiyeri Thalassery Kannur Kerala 670103 India
Approved
Institutional Ethics Commiittee I and II Main Building, 3rd floor, Tata Memorial hospital, Dr E Borges Marg, Parel, Mumbai 400012
Submittted/Under Review
Kims Kingsway Hospitals Ethics Committee, No 44, Parwana Bhawan, Kingsway, Nagpur 440001, Maharashtra, India
Approved
MPMMCC and HBCH Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar Bagiya, Near Nariya Gate,Banaras Hindu University Campus, Varanasi, Uttar Pradesh, 221005, India
Submittted/Under Review
Regency Hospital Ethics Committee, Regency Hospital A 2, Sarvodaya Nagar Kanpur, Kanpur Nagar Uttar Pradesh 208005 India
Submittted/Under Review
Spandana Oncology Centre No.919, New No. 68,2gth Main Road. 9th Block Jayanagar, Bangalore 560069
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Abiraterone
1000 mg of Abiraterone acetate film-coated tablets will be given orally Once daily for the duration of treatment.
Comparator Agent
Placebo to Saruparib
Placebo to match AZD5305 (Saruparib) film-coated tablets will be given orally Once daily for the duration of treatment.
Intervention
Saruparib
60 mg of AZD5305 (Saruparib)
film-coated tablets will be given orally Once daily for the duration of treatment.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Male
Details
1. Male participants with a histologically documented diagnosis of prostate adenocarcinoma
2. Newly diagnosed high risk and very high risk (localised or locally advanced) prostate cancer or a high risk biochemical recurrence (BCR) following radical prostatectomy
3. Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample
4. Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.
5. 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)
6. 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).
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.
8. Minimum life expectancy of 12 months.
9. Adequate organ and bone marrow function as described in study protocol.
10. 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.
11. All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.
12. 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.
13. 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.
ExclusionCriteria
Details
1. Participants with a history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) or with features suggestive of MDS or AML.
2. Participants with any known predisposition to bleeding [example active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy].
3. Any history of persisting (greater than 2 weeks) severe cytopenia due to any cause.
4. 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.
5. History of another primary malignancy, with exceptions.
6. Persistent toxicities [Common Terminology Criteria for Adverse Events (CTCAE) Grade greater than or equal to 2] caused by previous anticancer therapy.
7. Cardiac criteria, including history of arrhythmia and cardiovascular disease.
8. Evidence of active and uncontrolled hepatitis B and or hepatitis C.
9. Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
10. Active tuberculosis infection.
11. Any prior chemotherapy (i.e., docetaxel) or immunotherapy, any prior treatment with a poly (ADP ribose) polymerase (PARP) inhibitor.
12. Prior treatment within 14 days with blood product support or growth factor support.
13. 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.
14. Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).
15. Participants with a known hypersensitivity to saruparib or any excipients of these products.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Metastasis-free survival (MFS)
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.
Up to approximately 93 months
Secondary Outcome
Outcome
TimePoints
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Up to approximately 11 years
MFS (CT/MRI and bone scan)
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.
Up to approximately 93 months
MFS (PSMA-PET)
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.
Up to approximately 93 months
MFS (standard clinical imaging)
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.
Up to approximately 93 months
Time from randomisation to Progression Free Survival 2 (PFS2)
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.
Up to approximately 93 months
Time to biochemical recurrence
Time to biochemical recurrence is defined as the time from randomisation to biochemical recurrence per Phoenix criteria.
Up to approximately 93 months
Prostate cancer-specific survival (PCSS)
PCSS is defined as the time from randomisation until the date of death due to the underlying prostate cancer.
Up to approximately 11 years
Time to deterioration in urinary symptoms (TTDUS)
TTDUS is defined as the time from randomisation to deterioration in EORTC-QLQ-PR25 (US) subscale scores.
Up to approximately 93 months
Time to deterioration in physical function (TTDPF)
TTDPF is defined as the time from randomisation to deterioration in EORTC-QLQ-C30 Physical Function subscale scores.
Up to approximately 93 months
Plasma concentrations of saruparib
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).
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Area under the curve (AUC)
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).
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Maximum observed concentration (Cmax)
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).
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Time to Cmax (Tmax)
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).
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Number of participants with adverse events (AEs)
To assess the safety and tolerability of saruparib administered in combination with ADT alone (Cohort A) and in combination with ADT + abiraterone (Cohort B).
Up to approximately 11 years
Target Sample Size
Total Sample Size="700" Sample Size from India="32" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
29/12/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
06/08/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="11" Months="2" Days="2"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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).