Clinical Trials List
Protocol NumberD9727C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06952803
Not yet recruiting
2025-09-15 - 2036-04-30
Phase III
Recruiting3
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).
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
PAREXEL INTERNATIONAL CO., LTD.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YU-CHUAN LU Division of Urology
- JIAN-HUA HONG Division of Urology
- Yeong-Shiau Pu Division of Urology
- 王中傑 Division of Urology
- 呂紹綸 Division of Urology
- 張尚仁 Division of Urology
- 藍耿學 Division of Urology
- 王嘉儁 Division of Urology
- PO-MING CHOW Division of Urology
- - - Division of Urology
- 闕士傑 Division of Urology
- Chia-Hsien Chen Division of Urology
- YEN-HENG LIN Division of Urology
- CHING-CHU LU Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
See-Tong Pang
Co-Principal Investigator
- Hong-Cheng Gan Division of Hematology & Oncology
- I-hung Shao Division of Hematology & Oncology
- Rita cheng Division of Hematology & Oncology
- Po-Jung Su Division of Hematology & Oncology
- 吳俊德 Division of Hematology & Oncology
- 范綱行 Division of Hematology & Oncology
- 陳東藝 Division of Hematology & Oncology
- Kai-Jie Yu
- Yung-Chang Lin Division of Hematology & Oncology
- 張鈞弼 Division of Hematology & Oncology
- Jing-Ren Tseng Division of Hematology & Oncology
- PO-HUNG LIN Division of Hematology & Oncology
- 張境夫 Division of Hematology & Oncology
- 詹頂立 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
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.
Objectives
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).
Test Drug
saruparib
Active Ingredient
saruparib
Dosage Form
tablet
Dosage
20mg
Endpoints
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.
Inclution 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.
-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
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.
-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.
The Estimated Number of Participants
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Taiwan
36 participants
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Global
700 participants
