Testing Saruparib with Enzalutamide against a placebo for metastatic hormone-sensitive prostate cancer (mhspc)
Official title: Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)
A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05
- Phase 3
- 2 groups
- Sites in Calgary, Edmonton and 10 more cities
- Recruiting
Interventions (5)
- Medication
Saruparib
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
- Other intervention
Placebo
Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
- Medication
Enzalutamide
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
- Medication
Darolutamide
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
- Medication
Abiraterone
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
Canadian Sites (14)
1 of 14 recruiting
- Recruiting
Research Site
Montreal, Quebec
- Not yet recruiting
Research Site
Calgary, Alberta
- Not yet recruiting
Research Site
Edmonton, Alberta
- Not yet recruiting
Research Site
Abbotsford British Columbia, British Columbia
- Not yet recruiting
Research Site
Brampton, Ontario
- Not yet recruiting
Research Site
Kitchener, Ontario
- Not yet recruiting
Research Site
North York, Ontario
- Not yet recruiting
Research Site
Ottawa, Ontario
- Not yet recruiting
Research Site
Toronto, Ontario
- Not yet recruiting
Research Site
Windsor, Ontario
- Not yet recruiting
Research Site
Greenfield Park, Quebec
- Not yet recruiting
Research Site
Montreal, Quebec
- Not yet recruiting
Research Site
Saint-Jérôme, Quebec
- Not yet recruiting
Research Site
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participant must be ≥ 18 at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive.
- +Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC.
- +Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months.
- +Participants must have the following:
- +Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy.
- +Had no evidence of disease progression
- +Had all toxicities related to docetaxel- or Lu-PSMA-containing treatment (except for alopecia and peripheral neuropathy) resolved to CTCAE Grade 1 or lower.
- +PSA ≥ 0.2 ng/mL within 14 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +Serum testosterone \< 1.7 nmol/L or 50 ng/dL.
- +Provision of a FFPE tumor tissue sample and a blood sample (for ctDNA).
- +Confirmed HRRm, HRD and PTEN status.
- +Adequate organ and bone marrow function.
- +Minimum life expectancy of 6 months.
- +Male, assigned at birth, inclusive of all gender identities.
- +Capable of giving signed informed consent.
- +Contraceptive use by participants or participant partners should be consistent with local regulations.
- +Palliative radiotherapy for symptoms management will be permitted and is to be completed at least 4 weeks prior to randomization for wide field radiation therapy and at least 2 weeks prior to randomization for limited field radiation therapy.
Exclusion
- −Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label.
- −Spinal cord compression or brain metastases unless asymptomatic and stable.
- −Any history of persisting (\> 2 weeks) severe cytopenia due to any cause (eg, ANC\< 0.5 × 10\^9/L or platelets \< 50 × 10\^9/L)
- −Any known predisposition to bleeding (eg, active peptic ulceration, recent \[within6 months\] hemorrhagic stroke, proliferative diabetic retinopathy.
- −History of MDS/AML or with features suggestive of MDS/AML
- −History of another primary malignancy, with some exceptions.
- −Any chronic gastrointestinal diseases or conditions including inability to swallow the formulated product that would preclude adequate absorption of any study drug.
- −History of seizure or predispose to seizure, including any history of loss of consciousness or transient ischemic attack within 12 months of enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- −Serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- −Switched ARPI agent in previous treatment for mHSPC due to disease progression. Note: if the ARPI agent was switched due to any reason other than disease progression and switch was prior to ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more → signature, participants will be eligible.
- −Major surgical procedure or significant traumatic injury within 4 weeks of the first dose or an anticipated need for major surgery during the study.
- −Any prior treatment with a PARPi or platinum chemotherapy.
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 2 groups in this study.
Group A receives Saruparib, Enzalutamide, Darolutamide and Abiraterone.
Registry label: A: Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo, Enzalutamide, Darolutamide and Abiraterone.
Registry label: B: Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone
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 1,330 people.
The study is currently expected to finish around May 2033.
The main measurement is taken over: Up to approximately 56 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Radiographic progression-free survival (rPFS) — measured over Up to approximately 56 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07711002 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
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
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 PlaceboOther
Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About EnzalutamideDrug
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
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 DarolutamideDrug
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
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 AbirateroneDrug
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
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 56 months.
The study as a whole is currently expected to finish around 2033-05-27.
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 1,330 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Abbotsford British Columbia, British Columbia, Canada; Brampton, Ontario, Canada; Kitchener, Ontario, Canada; North York, Ontario, Canada, and 12 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 primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.
Other Sites (5)
Research Site
Detroit, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Marshall, Minnesota, United States
Research Site
Shirley, New York, United States
Research Site
Spokane, Washington, United States
If this study interests you
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This 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.