Clinical trial • Phase III • Oncology

SARUPARIB for Prostate cancer | BRCA1/BRCA2-mutated high-risk localized/locally advanced prostate cancer

Phase III trial of SARUPARIB for Prostate cancer | BRCA1/BRCA2-mutated high-risk localized/locally advanced prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Prostate cancer | BRCA1/BRCA2-mutated high-risk localized/locally advanced prostate cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
28-07-2025
First CTIS Authorization Date
12-11-2025

Trial design

Randomised, placebo to match (ptm) azd5305 film-coated tablets (placebo comparator). background treatment in both arms: standard radiotherapy (rt) + androgen deprivation therapy (adt) with a gnrh analogue. abiraterone acetate (zytiga 250 mg / 500 mg tablets) is listed among trial medicinal products (doses listed as 250 mg and 500 mg tablets) but dosing schedule in this trial is not specified in the ctis record.-controlled Phase III trial in Austria, Belgium, Hungary and others.

Randomised
Yes
Comparator
Placebo to match (PTM) AZD5305 film-coated tablets (placebo comparator). Background treatment in both arms: standard radiotherapy (RT) + androgen deprivation therapy (ADT) with a GnRH analogue. Abiraterone acetate (ZYTIGA 250 mg / 500 mg tablets) is listed among trial medicinal products (doses listed as 250 mg and 500 mg tablets) but dosing schedule in this trial is not specified in the CTIS record.
Biomarker Stratified
True, BRCA1/BRCA2 mutation status (central tumour tissue-confirmed BRCAm required for enrolment)
Target Sample Size
447

Eligibility

Recruits 447 No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial enrols adult male participants only. Informed consent is required from each adult participant; country-specific ICFs (main, screening, genetic, pregnant-partner and other addenda) are provided per country and language. No assent procedures for minors are described..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial enrols adult male participants only. Informed consent is required from each adult participant; country-specific ICFs (main, screening, genetic, pregnant-partner and other addenda) are provided per country and language. No assent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- Male participants with a histologically documented diagnosis of prostate adenocarcinoma."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy."}
  • {"criterion_text":"- Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample."}
  • {"criterion_text":"- Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization."}
  • {"criterion_text":"- Minimum life expectancy of 12 months."}
  • {"criterion_text":"- Adequate organ and bone marrow function as described in study protocol."}

Exclusion criteria

  • {"criterion_text":"- Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML."}
  • {"criterion_text":"- Active tuberculosis infection."}
  • {"criterion_text":"- Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor."}
  • {"criterion_text":"- Prior treatment within 14 days with blood product support or growth factor support."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP)."}
  • {"criterion_text":"- Participants with a known hypersensitivity to saruparib or any excipients of these products."}
  • {"criterion_text":"- Participants with any known predisposition to bleeding [e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy]."}
  • {"criterion_text":"- Any history of persisting (> 2 weeks) severe cytopenia due to any cause."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- History of another primary malignancy, with exceptions."}
  • {"criterion_text":"- Persistent toxicities [Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2] caused by previous anticancer therapy."}
  • {"criterion_text":"- Cardiac criteria, including history of arrhythmia and cardiovascular disease."}
  • {"criterion_text":"- Evidence of active and uncontrolled hepatitis B and/or hepatitis C."}
  • {"criterion_text":"- Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"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."}

Secondary endpoints

  • {"endpoint_text":"- OS is defined as the time from randomisation until the date of death due to any cause.","definition_or_measurement_approach":"OS: time from randomisation until death due to any cause."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"MFS by conventional imaging (CT/MRI and bone scan) or death."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"MFS confirmed by PSMA-PET imaging or death."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"MFS confirmed by standard imaging (CT/MRI + bone scan or PSMA-PET), histology, or death."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"PFS2: time from randomisation to earliest second progression following first subsequent systemic treatment after initial investigator-assessed progression, or death; second progression assessed by investigator per local practice."}
  • {"endpoint_text":"- Time to biochemical recurrence is defined as the time from randomisation to biochemical recurrence per Phoenix criteria.","definition_or_measurement_approach":"Biochemical recurrence per Phoenix criteria: time from randomisation to recurrence."}
  • {"endpoint_text":"- PCSS is defined as the time from randomisation until the date of death due to the underlying prostate cancer.","definition_or_measurement_approach":"PCSS: time from randomisation until death due to prostate cancer."}
  • {"endpoint_text":"- TTDUS is defined as the time from randomisation to deterioration in EORTC-QLQ-PR25 (US) subscale scores.","definition_or_measurement_approach":"TTDUS: time from randomisation to deterioration in EORTC-QLQ-PR25 urinary symptoms subscale scores."}
  • {"endpoint_text":"- TTDPF is defined as the time from randomisation to deterioration in EORTC-QLQ-C30 Physical Function subscale scores","definition_or_measurement_approach":"TTDPF: time from randomisation to deterioration in EORTC-QLQ-C30 physical function subscale."}
  • {"endpoint_text":"- 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).","definition_or_measurement_approach":"Pharmacokinetic assessment of saruparib plasma concentrations with or without abiraterone and exploration of PK–PD relationships with selected efficacy/safety endpoints."}

Recruitment

Planned Sample Size
447
Recruitment Window Months
125
Consent Approach
Informed consent obtained from each adult participant via country-specific subject information and informed consent forms (multiple country ICF documents provided: main ICF, screening, genetic research, pregnant-partner forms, addenda; available in country languages as per document list). Pregnant partner information/ICF documents are provided for partners where applicable. No mention of assent (trial enrols adult males only).

Geography

Total Number Of Sites
125
Total Number Of Participants
447

Austria

Earliest CTIS Part Ii Submission Date
22-10-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
26
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Medical University Of Vienna
Department Name
0403 Universitätsklinik für Urologie
Contact Person Name
Gero Kramer
Contact Person Email
gero.kramer@meduniwien.ac.at
Site Name
Ordensklinikum Linz GmbH
Department Name
0404 Abteilung für Urologie und Andrologie
Contact Person Name
Ferdinand Luger
Site Name
Medical University Of Graz
Department Name
0405 Klinische Abteilung fuer Onkologie
Contact Person Name
Angelika Terbuch
Contact Person Email
angelika.terbuch@medunigraz.at
Site Name
Krankenhaus Der Barmherzigen Brueder Wien
Department Name
0402 Abteilung für Innere Medizin II
Contact Person Name
Johannes Meran
Contact Person Email
johannes.meran@bbwien.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
0401 Universitätsklinik für Urologie
Contact Person Name
Isabel Heidegger-Pircher

Belgium

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
23
Number Of Sites
6
Number Of Participants
11

Sites

Site Name
Institut Jules Bordet
Department Name
0505 Oncologie Médicale
Contact Person Name
Nieves Martinez Chanza
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
0501 Urologie
Contact Person Name
Karl Lesage
Contact Person Email
karl.lesage@azgroeninge.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
0503 Urology
Contact Person Name
Lieven Goeman
Contact Person Email
lieven.goeman@azdelta.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
0502 Oncology/Radiotherapy
Contact Person Name
Piet Ost
Contact Person Email
piet.ost@zas.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
0504 Medical oncology/Institut Roi Albert II
Contact Person Name
Emmanuel Seront
Site Name
UZ Brussel
Department Name
0507 Medical oncology
Contact Person Name
Sandrine Aspeslagh

Hungary

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
14-11-2025
Processing Time Days
22
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
University Of Debrecen
Department Name
3301; Urológiai Klinika
Contact Person Name
Tibor Flaskó
Contact Person Email
flash@med.unideb.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
3305; Megyei Onkológia és Sugárterápiás Centrum
Contact Person Name
László Torday
Contact Person Email
laszlo.torday@gmail.com
Site Name
Semmelweis University
Department Name
3307; Urológiai Klinika
Contact Person Name
Péter Nyirády
Contact Person Email
nyirady.peter@semmelweis.hu
Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
3306; Onkológiai Osztály
Contact Person Name
Károly Máhr
Contact Person Email
mahrkaroly@hotmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
3302 Gyógyszerterápiás Központ Urogenitális Tumorok és Klinikai Farmakológiai Osztály, Kemoterápia C
Contact Person Name
Lajos Géczi
Contact Person Email
gelajos@oncol.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
3304; Onkoradiológiai Osztály
Contact Person Name
András Szigeti
Contact Person Email
drszigetia.petz@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
06-11-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
11
Number Of Sites
15
Number Of Participants
21

Netherlands

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
10
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Canisius Wilhelmina Ziekenhuis
Department Name
5003; Nuclear Medicine
Contact Person Name
Rik Somford
Contact Person Email
r.somford@cwz.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
5005; Urology
Contact Person Name
Joep van Roermund
Contact Person Email
joep.van.roermund@mumc.nl
Site Name
Bravis Ziekenhuis
Department Name
5004; Oncology
Contact Person Name
Steve Boudewijns
Contact Person Email
s.boudewijns@bravis.nl
Site Name
Tergooiziekenhuizen
Department Name
5001; Internal Medicine/Hemato-Oncology
Contact Person Name
Hendrik Van Den Berg
Contact Person Email
pvandenberg@tergooi.nl

Italy

Earliest CTIS Part Ii Submission Date
06-11-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
11
Number Of Sites
19
Number Of Participants
25

Finland

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
20
Number Of Sites
6
Number Of Participants
11

Sites

Site Name
Tampere University Hospital
Department Name
2202 Department of Urology
Contact Person Name
Teemu Murtola
Contact Person Email
teemu.murtola@pirha.fi
Site Name
Kuopio University Hospital
Department Name
2201 Department of Oncology
Contact Person Name
Okko Sakari Kääriäinen
Site Name
Oulu University Hospital
Department Name
2206 Department of Urology
Contact Person Name
Hanna-Maria Ronkainen
Contact Person Email
hanna.ronkainen@pohde.fi
Site Name
Turku University Hospital
Department Name
2205 Urology
Contact Person Name
Otto Ettala
Contact Person Email
Otto.Ettala@varha.fi
Site Name
Docrates Oy
Department Name
2204 Department of Oncology
Contact Person Name
Jorma Sormunen
Contact Person Email
jorma.sormunen@docartes.fi
Site Name
HUS-yhtymae
Department Name
2203 Urology
Contact Person Name
Antti Rannikko
Contact Person Email
antti.rannikko@hus.fi

Germany

Earliest CTIS Part Ii Submission Date
21-10-2025
Latest Decision Or Authorization Date
14-11-2025
Processing Time Days
24
Number Of Sites
18
Number Of Participants
25

Sweden

Earliest CTIS Part Ii Submission Date
16-10-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
27
Number Of Sites
6
Number Of Participants
6

France

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
24
Number Of Sites
28
Number Of Participants
92

Poland

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
15-11-2025
Processing Time Days
26
Number Of Sites
8
Number Of Participants
23

Sites

Site Name
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
Department Name
5703: Oddzial Chemioterapii
Contact Person Name
Iwona Skoneczna
Contact Person Email
iskoneczna@grochowski.waw.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
5705: Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
5707: Oddzial w Gliwicach Oddział Chemioterapii Dziennej
Contact Person Name
Wieslaw Bal
Contact Person Email
bal.wieslaw@gmail.com
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Department Name
5701: Oncology
Contact Person Name
Ilona Bar-Letkiewicz
Site Name
Pratia S.A.
Department Name
5704: Pratia MCM Krakow
Contact Person Name
Anna Drosik-Kwasniewska
Contact Person Email
adrosik-kwasniewska@pratia.com
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
5706: Szpital Morski im. PCK Oddzial Onkologii i Radioterapii
Contact Person Name
Dorota Filarska
Contact Person Email
d.filarska@szpital-morski.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o. S.K.
Department Name
5702: Centrum Medyczne MEDYK
Contact Person Name
Kamil Kuc
Contact Person Email
kkuc@wszp.pl
Site Name
Provita Centrum Medyczne Sp. z o.o.
Department Name
5708: Provita Profamilia
Contact Person Name
Michal Maslowski
Contact Person Email
maslowskimichal@gmail.com

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Sponsor-related duties (sponsorDuties codes: 1,10,11,12,13,2,5,6,8) and operational support (contact: Clinicaltrial.Enquiries@parexel.com)

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,2,5,6,8 (as listed in CTIS)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Saruparib
Active Substance
SARUPARIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Investigational (CTIS product record: sponsor product AZD5305, prodAuthStatus indicated as investigational in CTIS)
Investigational Product Name
Placebo to match (PTM) AZD5305 film-coated tablets
Modality
Other
Authorisation Status
Not applicable (placebo)
Investigational Product Name
ZYTIGA 250 mg tablets / ZYTIGA 500 mg film-coated tablets
Active Substance
ABIRATERONE ACETATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisations listed in CTIS: EU/1/11/714/001 and EU/1/11/714/002 / PRD numbers in CTIS)
Starting Dose
Available in 250 mg and 500 mg tablet strengths (as listed)
Dose Levels
250 mg | 500 mg
Combination Treatment
Yes

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