癌研連線CancerLink
招募中 NCT07711002

Saruparib 联合医生选择的 ARPI 用于曾接受 docetaxel 或 177Lu-PSMA 治疗、无疾病进展且 PSA ≥ 0.2 ng/mL 的 mHSPC 患者（EvoPAR-PR05）

前列腺癌白血病Phase IIIIII 期IV 期HRDPSMA

本研究的主要目的是在曾接受 docetaxel 化疗或针对前列腺特异性膜抗原（PSMA）的 lutetium-177 放射配体治疗、无疾病进展证据且 PSA ≥ 0.2 ng/mL 的转移性激素敏感前列腺癌（mHSPC）男性患者中，评估 saruparib 联合医生选择的 ARPI 与安慰剂联合 ARPI 相比的疗效。

适应症：Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

入组条件

纳入标准

  • 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.
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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.
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入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年11月5日。