CTRI/2025/10/096699尚未招募3 期
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)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 8
- 主要终点
- Metastasis-free survival (MFS)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male participants with a histologically documented diagnosis of prostate adenocarcinoma
- •Newly diagnosed high risk and very high risk (localised or 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)
- •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.
- •Radiotherapy administered to the prostate (pelvis) either in the primary or salvage setting must be delivered with curative intent.
- •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.
排除标准
- •Participants with a history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) or with features suggestive of MDS or AML.
- •Participants with any known predisposition to bleeding [example active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy].
- •Any history of persisting (greater than 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 greater than or equal to 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.
结局指标
主要结局
Metastasis-free survival (MFS)
时间窗: Up to approximately 93 months
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.
时间窗: Up to approximately 93 months
次要结局
- Overall Survival (OS)(OS is defined as the time from randomisation until the date of death due to any cause.)
- 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.)
- 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.)
- 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 from randomisation to Progression Free Survival 2 (PFS2)(Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression [defined as radiographic progression, clinical progression, or prostate-specific antigen (PSA) progression] after initiation of first subsequent systemic treatment following the initial investigator-assessed progression or death. The date of second progression will be investigator assessed according to local standard clinical practice.)
- Time to biochemical recurrence(Time to biochemical recurrence is defined as the time from randomisation to biochemical recurrence per Phoenix criteria.)
- Prostate cancer-specific survival (PCSS)(PCSS is defined as the time from randomisation until the date of death due to the underlying prostate cancer.)
- Time to deterioration in urinary symptoms (TTDUS)(TTDUS is defined as the time from randomisation to deterioration in EORTC-QLQ-PR25 (US) subscale scores.)
- Time to deterioration in physical function (TTDPF)(TTDPF is defined as the time from randomisation to deterioration in EORTC-QLQ-C30 Physical Function subscale scores.)
- Plasma concentrations of saruparib(To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).)
- Area under the curve (AUC)(To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).)
- Maximum observed concentration (Cmax)(To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).)
- Time to Cmax (Tmax)(To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).)
- Number of participants with adverse events (AEs)(To assess the safety and tolerability of saruparib administered in combination with ADT alone (Cohort A) and in combination with ADT + abiraterone (Cohort B).)
研究者
Dr Annappa Kamath
Parexel International Clinical Research Private Limited
研究点 (8)
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