進行中(不再收案) NCT03456843

細胞減滅性根治性前列腺切除術對新診斷轉移性前列腺癌男性的治療效果

前列腺癌Phase IIIII 期IV 期

這是一項2.5期國際性、多機構、隨機臨床試驗,旨在前瞻性評估細胞減滅性根治性前列腺切除術(CRP)聯合最佳支持治療(BST)對轉移性前列腺癌(mPCa)男性的潛在治療效果。此混合設計允許將已納入第二期研究的患者納入第三期試驗,從而減少整體所需患者數量(5-7)。在初始第二期研究中,我們計劃納入190名患者。

適應症:Stage IV Prostate Adenocarcinoma AJCC v7

收案條件

納入條件

  • 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

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。