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。