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。