NCT07711002尚未招募3 期
A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 1,330
- 试验地点
- 2
- 主要终点
- Radiographic progression-free survival (rPFS)
研究概览
简要总结
The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 at the time of signing the informed consent.
- •Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive.
- •Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC.
- •Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months.
- •Participants must have the following:
- •Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy.
- •Had no evidence of disease progression
- •Had all toxicities related to docetaxel- or Lu-PSMA-containing treatment (except for alopecia and peripheral neuropathy) resolved to CTCAE Grade 1 or lower.
- •PSA ≥ 0.2 ng/mL within 14 days prior to randomization.
- •Serum testosterone < 1.7 nmol/L or 50 ng/dL.
- •Palliative radiotherapy for symptoms management will be permitted and is to be completed at least 4 weeks prior to randomization for wide field radiation therapy and at least 2 weeks prior to randomization for limited field radiation therapy.
- •Provision of a FFPE tumor tissue sample and a blood sample (for ctDNA).
- •Confirmed HRRm, HRD and PTEN status.
- •Adequate organ and bone marrow function.
- •Minimum life expectancy of 6 months.
- •Male, assigned at birth, inclusive of all gender identities.
- •Contraceptive use by participants or participant partners should be consistent with local regulations.
- •Capable of giving signed informed consent.
排除标准
- •Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label.
- •Any history of persisting (> 2 weeks) severe cytopenia due to any cause (eg, ANC< 0.5 × 10^9/L or platelets < 50 × 10^9/L)
- •Any known predisposition to bleeding (eg, active peptic ulceration, recent [within6 months] hemorrhagic stroke, proliferative diabetic retinopathy.
- •Spinal cord compression or brain metastases unless asymptomatic and stable.
- •History of MDS/AML or with features suggestive of MDS/AML
- •History of another primary malignancy, with some exceptions.
- •Any chronic gastrointestinal diseases or conditions including inability to swallow the formulated product that would preclude adequate absorption of any study drug.
- •History of seizure or predispose to seizure, including any history of loss of consciousness or transient ischemic attack within 12 months of enrolment.
- •Serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- •Major surgical procedure or significant traumatic injury within 4 weeks of the first dose or an anticipated need for major surgery during the study.
- •Switched ARPI agent in previous treatment for mHSPC due to disease progression. Note: if the ARPI agent was switched due to any reason other than disease progression and switch was prior to ICF signature, participants will be eligible.
- •Any prior treatment with a PARPi or platinum chemotherapy.
结局指标
主要结局
Radiographic progression-free survival (rPFS)
时间窗: Up to approximately 56 months
Radiographic PFS (rPFS) is the primary endpoint of this study, defined as the time from randomization to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.
次要结局
- Overall Survival (OS)(Up to approximately 80 months)
- Radiographic progression-free survival (rPFS)(Up to approximately 56 months)
- Time to Second Progression or Death (PFS2)(Up to approximately 56 months)
- Time to First Subsequent Therapy or Death (TFST)(Up to approximately 56 months)
- Symptomatic Skeletal Event-free Survival (SSE-FS)(Up to approximately 56 months)
- Time to Castration Resistance (TTCR)(Up to approximately 56 months)
- Time to PSA progression(Up to approximately 56 months)
- Time to deterioration in physical function (TTDPF)(Up to approximately 56 months)
- Time to pain progression (TTPP)(Up to approximately 56 months)
- Brief Pain Inventory - Short Form (BPI-SF)(Up to approximately 56 months)
- Time to deterioration in urinary symptoms (TTDUS)(Up to approximately 56 months)
- Plasma concentrations of AZD5305(Day 1 of Cycle 1, Cycle 2 and Cycle 3 (each cycle is of 28 days))
研究者
研究点 (2)
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