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Protocol NumberD9727C00001
Not yet recruiting

2025-09-15 - 2036-04-30

Phase III

Recruiting8

A randomized, double-blind, placebo-controlled phase III trial is evaluating adjuvant saruparib (AZD5305) (EvoPAR-Prostate02) in patients with locally high-risk prostate cancer of the breast cancer gene mutation (BRCAm) who are currently receiving radiation therapy and androgen deprivation therapy.

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Parexel International Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/21

Investigators and Locations

Principal Investigator 羅浩倫 Division of Urology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHUNG-HSIN CHEN Division of Urology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Shyan Tsai Division of Urology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 洪晟鈞 Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 歐宴泉 Division of Urology
童綜合醫療社團法人童綜合醫院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator SHAUH-DER YEH Division of Urology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiu Huang Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator See-Tong Pang
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastasis-free survival (MFS) [Time range: approximately 93 months] - MFS is defined as the time elapsed from the date of randomization until the day of first diagnosis of distant metastasis as assessed by BICR (confirmed by standard clinical imaging [CT/MRI and bone scan, or PSMA-PET]) or death from any cause.

Objectives

Primary Objective: In participants (Group A) with high-risk and very high-risk (locally/locally advanced) prostate cancer with BRCA1/2 mutations who received initial or rescue RT, demonstrating the superiority of adding adjuvant saruparib to standard ADT therapy compared to adding placebo, based on MFS as assessed by standard clinical imaging using BICR. In participants (Group B) with locally very high-risk prostate cancer with BRCA1/2 mutations who received initial RT, demonstrating the superiority of adding adjuvant saruparib to standard ADT therapy plus abiraterone compared to adding placebo, based on MFS as assessed by standard clinical imaging using BICR. Key Secondary Objective: In Group A participants, demonstrating the superiority of adding adjuvant saruparib to standard ADT therapy compared to adding placebo, based on OS assessment. Through OS assessment, in group B participants, the superiority of adding adjuvant saraparib to standard ADT therapy with abiraterone over adding placebo was demonstrated.

Test Drug

AZD5305

Active Ingredient

saruparib

Dosage Form

Tablets

Dosage

20mg

Endpoints

Metastasis-free survival (MFS) [Time range: approximately 93 months]

-MFS is defined as the time elapsed from the date of randomization until the day of first assessment by BICR of distant metastasis (confirmed by standard clinical imaging [CT/MRI and bone scan, or PSMA-PET]) or death from any cause.

Inclution Criteria

- Participants must have a histologically confirmed diagnosis of prostate adenocarcinoma.

- Participants newly diagnosed with high-risk or very high-risk (locally/locally advanced) prostate cancer, or those who have undergone radical prostatectomy and have a high risk of biochemical recurrence (BCR).

- Provide formalin-fixed paraffin-embedded (FFPE) tumor tissue samples.

- Confirmation of BRCA1 or BRCA2 mutation status via central tumor tissue is required for inclusion.

- All participants must undergo computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan after completing their scheduled radiotherapy (RT). This screening scan must confirm the absence of disease evidence, or that the disease evidence is limited to the pelvis (M0).

- All participants must undergo prostate-specific membrane antigen-positron emission tomography (PSMA-PET) after completing their scheduled RT. This screening scan must confirm the absence of disease evidence, or that the disease evidence is limited to the pelvis (M0).

- Participants must have an Eastern Coast Cancer Clinical Research Group (ECOG) performance status of 0 or 1 and be free of deterioration in the two weeks prior to randomization.

- Minimum life expectancy of 12 months.

- Adequate organ and bone marrow function.

- All participants must have received initial or rescue radiation therapy. Radiation therapy to the prostate (→ pelvis) in initial or rescue settings must be curative. Metastasis-directed therapy is permitted in radiation therapy programs as local radiation therapy to extrapelvic metastases.

- All participants must have received a pre-planned course of androgen deprivation therapy and gonadotropin-releasing hormone (GnRH) analogue therapy.

- Participants must not impregnate others or donate sperm from the date of signing the participant consent form, during the trial intervention, and for six months after the last dose of the trial intervention.

- Participants must use condoms (and spermicide if permitted) with all sexual partners from the date of signing the participant consent form, during the trial intervention, and for six months after the last dose of the investigational drug.

Exclusion Criteria

- Participants with a history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features pointing to MDS/AML.

- Participants with any known bleeding tendency.

- History of persistent (>2 weeks) severe cytopenia for any reason.

- Refractory nausea and vomiting, chronic gastrointestinal disorders, inability to swallow prescription medications, or extensive bowel resection resulting in inadequate absorption of saruparib and/or abiraterone.

- History of another primary malignancy, with exceptions.

- Cardiac criteria, including a 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.

- Previous treatment with any chemotherapy (i.e., docetaxel) or immunotherapy; previous treatment with any poly(ADP-ribose) polymerase inhibitor.

- Received blood product support or growth factor support within 14 days.

- Received a potent inducer or inhibitor of CYP3A4 (saruparib and abiraterone) or herbal supplement within 21 days or at least 5 half-lives (whichever is longer) during randomization.

- Received medications known to prolong QT and with a known risk of multiform ventricular tachycardia (TdP).

- Known hypersensitivity to saruparib or any of its excipients.

The Estimated Number of Participants

  • Taiwan

    36 participants

  • Global

    700 participants

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