进行中(不再招募) NCT03456843

细胞减灭性根治性前列腺切除术对新诊断转移性前列腺癌男性的治疗效果

前列腺癌Phase IIIII 期IV 期

这是一项2.5期国际性、多机构、随机临床试验,旨在前瞻性评估细胞减灭性根治性前列腺切除术(CRP)联合最佳支持治疗(BST)对转移性前列腺癌(mPCa)男性的潜在治疗效果。此混合设计允许将已纳入第二期研究的患者纳入第三期试验,从而减少整体所需患者数量(5-7)。在初始第二期研究中,我们计划纳入190名患者。

适应症:Stage IV Prostate Adenocarcinoma AJCC v7

入组条件

纳入标准

  • Histologically proven adenocarcinoma of the prostate
  • Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
  • Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis.
  • If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET \[positron emission tomography\], bone scan and MRI, modality at the discretion of the treating physician)
  • No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.)
  • Give informed consent
  • Prostate deemed resectable by surgeon
  • Plans to start or has already started ADT no longer than 6 months prior to consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Hemoglobin (HgB) \>= 9 g/dL compatible for surgery
  • Platelets \> 80,000/mcL compatible for surgery
  • Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery
  • Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery

排除标准

  • Refuses to give informed consent
  • Deemed to have unresectable disease by surgeon
  • Received ADT for more than 6 months prior to consent
  • Life expectancy of less than 6 months prior to consent
  • Active spinal cord compression
  • Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent
  • Previous local therapy for prostate cancer
  • Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent

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10月8日。