RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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).

Quick Facts

Study Start:2025-08-06
Study Completion:2036-05-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06952803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
  2. * Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.
  3. * Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
  4. * Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.
  5. * 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).
  6. * 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).
  7. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.
  8. * Minimum life expectancy of 12 months.
  9. * Adequate organ and bone marrow function as described in study protocol.
  10. * 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.
  11. * All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.
  12. * 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.
  13. * 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.
  1. * Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
  2. * Participants with any known predisposition to bleeding \[e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy\].
  3. * Any history of persisting (\> 2 weeks) severe cytopenia due to any cause.
  4. * 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.
  5. * History of another primary malignancy, with exceptions.
  6. * Persistent toxicities \[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2\] caused by previous anticancer therapy.
  7. * Cardiac criteria, including history of arrhythmia and cardiovascular disease.
  8. * Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
  9. * Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
  10. * Active tuberculosis infection.
  11. * Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.
  12. * Prior treatment within 14 days with blood product support or growth factor support.
  13. * 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.
  14. * Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).
  15. * Participants with a known hypersensitivity to saruparib or any excipients of these products.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85054
United States
Research Site
Tucson, Arizona, 85741
United States
Research Site
La Jolla, California, 92037
United States
Research Site
La Jolla, California, 92093
United States
Research Site
San Diego, California, 92123
United States
Research Site
San Luis Obispo, California, 93401
United States
Research Site
Lakewood, Colorado, 80215
United States
Research Site
Hialeah, Florida, 33016
United States
Research Site
Tampa, Florida, 33612
United States
Research Site
Newnan, Georgia, 30265
United States
Research Site
Jeffersonville, Indiana, 47130
United States
Research Site
Bethesda, Maryland, 20817
United States
Research Site
Towson, Maryland, 21204
United States
Research Site
Hackensack, New Jersey, 07601
United States
Research Site
Voorhees Township, New Jersey, 08043
United States
Research Site
Springfield, Oregon, 97477
United States
Research Site
Hershey, Pennsylvania, 17033
United States
Research Site
Pittsburgh, Pennsylvania, 15212
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Myrtle Beach, South Carolina, 29572
United States
Research Site
Nashville, Tennessee, 37209
United States
Research Site
Austin, Texas, 78745
United States
Research Site
Houston, Texas, 77074
United States
Research Site
San Antonio, Texas, 78229
United States
Research Site
Spring, Texas, 77380
United States
Research Site
Salt Lake City, Utah, 84112
United States
Research Site
Norfolk, Virginia, 23502
United States
Research Site
Roanoke, Virginia, 24014
United States
Research Site
Virginia Beach, Virginia, 23462
United States
Research Site
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-06
Study Completion Date2036-05-22

Study Record Updates

Study Start Date2025-08-06
Study Completion Date2036-05-22

Terms related to this study

Keywords Provided by Researchers

  • Localised/locally advanced prostate cancer
  • High-risk biochemical recurrence (BCR)
  • Poly (ADP-ribose) polymerase
  • Radiation therapy or radiotherapy
  • Breast cancer gene (BRCA) mutation

Additional Relevant MeSH Terms

  • Prostate Cancer