Testing Saruparib against a placebo for prostate cancer
Official 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
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).
- Phase 3
- 4 groups
- Sites in Toronto, Calgary and 8 more cities
- Recruiting
Interventions (4)
- Medication
Saruparib
Saruparib will be administered orally.
- Medication
Placebo
Matching placebo to saruparib will be administered orally.
- Medication
Abiraterone + Prednisolone/Prednisone
Abiraterone will be administered orally in combination with prednisone/prednisolone.
- Medication
Androgen Deprivation Therapy (ADT)
Standard of care ADT will be administered.
Canadian Sites (11)
11 listed, none recruiting
- Withdrawn
Research Site
Calgary, Alberta
- Withdrawn
Research Site
Abbotsford British Columbia, British Columbia
- Withdrawn
Research Site
Vancouver, British Columbia
- Withdrawn
Research Site
Barrie, Ontario
- Withdrawn
Research Site
Brampton, Ontario
- Withdrawn
Research Site
London, Ontario
- Withdrawn
Research Site
Toronto, Ontario
- Withdrawn
Research Site
Chicoutimi, Quebec
- Withdrawn
Research Site
Montreal, Quebec
- Withdrawn
Research Site
Saskatoon, Saskatchewan
- Withdrawn
Research Site
Toronto
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- +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.
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +Minimum life expectancy of 12 months.
- +Adequate organ and bone marrow function as described in study protocolProtocolThe detailed plan a study must follow.Read more →.
- +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 formInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (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.
- +All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within 10 months of initial diagnosis (de novo or BCR). 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 localised RT treatment for a metastatic lesion(s) outside the pelvis.
Exclusion
- −Participants with a known hypersensitivity to saruparib or any excipients of these products.
- −Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
- −Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
- −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 \[Common Terminology Criteria for Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (CTCAE) Grade ≥ 2\] caused by previous anticancer therapy.
- −Cardiac criteria, including history of arrhythmia and cardiovascular disease.
- −Active tuberculosis infection.
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).
- −Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A receives Saruparib, together with one or more of: Androgen Deprivation Therapy (ADT).
Registry label: A: Cohort A: Saruparib (AZD5305) + Physician's Choice ADT
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo, together with one or more of: Androgen Deprivation Therapy (ADT).
Registry label: B: Cohort A: Placebo + Physician's Choice ADT
Group C receives Saruparib, together with one or more of: Abiraterone + Prednisolone/Prednisone and Androgen Deprivation Therapy (ADT).
Registry label: C: Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
Group D, the placebo group, receives Placebo, together with one or more of: Abiraterone + Prednisolone/Prednisone and Androgen Deprivation Therapy (ADT).
Registry label: D: Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists male participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 700 people.
The study is currently expected to finish around April 2036.
The main measurement is taken over: Up to approximately 93 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Metastasis-free survival (MFS) — measured over Up to approximately 93 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06952803 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SaruparibDrug
Saruparib will be administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Matching placebo to saruparib will be administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Abiraterone + Prednisolone/PrednisoneDrug
Abiraterone will be administered orally in combination with prednisone/prednisolone.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Androgen Deprivation Therapy (ADT)Drug
Standard of care ADT will be administered.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists male participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 93 months.
The study as a whole is currently expected to finish around 2036-04-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 700 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 16 locations, including: Toronto, Canada; Calgary, Alberta, Canada; Abbotsford British Columbia, British Columbia, Canada; Vancouver, British Columbia, Canada; Barrie, Ontario, Canada; Brampton, Ontario, Canada, and 10 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Other Sites (5)
Research Site
Rochester, Minnesota, United States
Research Site
Albany, New York, United States
Research Site
New York, New York, United States
Research Site
Syracuse, New York, United States
Research Site
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.