RecruitingPhase 3

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).

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether saruparib helps men live longer without prostate cancer spreading, compared with a placebo (a pill with no active drug). Both are added to standard radiation and hormone treatment. It is for men with high-risk prostate cancer and a BRCA1 or BRCA2 gene change.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be male and have prostate adenocarcinoma, a type of cancer confirmed by a tissue test.
  • Have newly diagnosed high-risk or very high-risk prostate cancer in or near the prostate, or high-risk signs of cancer returning on blood tests after surgery to remove the prostate.
  • Provide a tumor tissue sample. The study's central lab must confirm a BRCA1 or BRCA2 gene change.
  • After planned radiation, have a CT or MRI, a bone scan, and a PSMA-PET scan. These must show no cancer or cancer only in the pelvis.
  • Be fully active or able to do light work, with no decline in the past 2 weeks. Have healthy enough organs and bone marrow, and be expected to live at least 12 months.
  • Have received radiation meant to cure the cancer and a planned course of hormone treatment called a GnRH analogue. Be able to enter a study group within 10 months of diagnosis or signs of cancer returning.
  • Do not father a child or donate sperm from signing the consent form until 6 months after the last study dose.
  • Use a condom with all sexual partners during that same period, with spermicide where allowed.

Who can't join

  • Have or have had MDS or AML (bone marrow or blood cancers), signs of these conditions, severe low blood cell counts lasting over 2 weeks, or a known risk of bleeding.
  • Have hard-to-control nausea or vomiting, long-term gut disease, trouble swallowing the study medicine, or past bowel surgery that would prevent enough medicine from being absorbed.
  • Have had another cancer, with some exceptions, or still have moderate or worse side effects from past cancer treatment.
  • Have certain heart conditions, including heart rhythm problems or heart and blood vessel disease.
  • Have active, uncontrolled hepatitis B, hepatitis C, or HIV, or active tuberculosis.
  • Have had chemotherapy, immunotherapy, or a PARP inhibitor (a type of cancer drug), or received blood products or medicines to boost blood cell growth within the past 14 days.
  • Use certain medicines that affect how the body processes the study drugs, herbal supplements within the restricted time before joining a study group, or medicines that can cause a dangerous heart rhythm.
  • Have a known allergy to saruparib or its ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. * 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). * 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 randomization. * Minimum life expectancy of 12 months. * Adequate organ and bone marrow function as described in study protocol. * 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. * 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 form (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. Exclusion Criteria: * 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 \[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2\] caused by previous anticancer therapy. * Cardiac criteria, including history of arrhythmia and cardiovascular disease. * Evidence of active and uncontrolled hepatitis B and/or hepatitis C. * Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection. * Active tuberculosis infection. * Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor. * 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 randomization. * Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP). * Participants with a known hypersensitivity to saruparib or any excipients of these products.

Study sites (45)

AZ

CA

CO

FL

GA

IL

IN

MA

MD

MN

NJ

NY

OH

OR

PA

RI

SC

TN

TX

UT

VA

WA