Health Trials

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

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorAstraZeneca

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saruparib

    Drug

    Saruparib will be administered orally.

  • Placebo

    Drug

    Matching placebo to saruparib will be administered orally.

  • Abiraterone + Prednisolone/Prednisone

    Drug

    Abiraterone will be administered orally in combination with prednisone/prednisolone.

  • Androgen Deprivation Therapy (ADT)

    Drug

    Standard of care ADT will be administered.

Treatment groups

700 Participants
are divided into 4 treatment groups
Group A: Cohort A: Saruparib (AZD5305) + Physician's Choice ADTExperimental treatment 2 interventions
Group B: Cohort A: Placebo + Physician's Choice ADTPlacebo comparator 2 interventions
Group C: Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)Experimental treatment 3 interventions
Group D: Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)Placebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to approximately 93 months

Secondary outcomes

1

Overall Survival (OS)

OS is defined as the time from randomisation until the date of death due to any cause.

Time frame
Up to approximately 11 years
2

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.

Time frame
Up to approximately 93 months
3

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.

Time frame
Up to approximately 93 months
4

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.

Time frame
Up to approximately 93 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Parexel

Collaborator

Source ClinicalTrials.gov
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