MD Anderson Cancer Centre, University of Texas, Houston, TX, USA.
Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
BJU Int. 2020 Jun;125(6):792-800. doi: 10.1111/bju.15055. Epub 2020 Apr 7.
To review the ongoing randomised trials of cytoreductive prostatectomy (CRP) in de novo hormone-sensitive metastatic prostate cancer (HSPC) in order to identify their goals and assess their strengths and weaknesses.
PubMed, MEDLINE and clinical trials websites searches were performed to identify currently ongoing trials of CRP in de novo HSPC.
Nine randomised clinical trials in CRP were identified and included: Southwest Oncology Group (SWOG) 1802, Surgery in Metastatic Carcinoma of Prostate (SIMCAP), Adjuvant Treatments to the Local Tumour for Metastatic Prostate Cancer: Assessment of Novel Treatment Algorithms (IP2-ATLANTA), Testing Radical prostatectomy in men with prostate cancer and oligoMetastases to the bone (TRoMbone), Impact of Radical Prostatectomy as Primary Treatment in Patients with Prostate Cancer with Limited Bone Metastases (g-RAMPP), Cytoreductive Prostatectomy vs Cytoreductive Prostate Irradiation as a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial (LoMP II), Androgen-Deprivation Therapy or Androgen-Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery) (FUSCC-OMPCa), and the Testing Radical Prostatectomy in Chinese Men with Prostate Cancer and oligoMetastases to the Bone study. Each study was different; assessing various primary outcome measures including overall survival (OS), progression-free survival and feasibility to randomise between standard therapy and CRP or between radiation therapy and CRP in the metastatic setting. In the oligometastatic setting, the trials assess OS, feasibility to randomise and time to castration resistance. Similarly, a number of secondary endpoints ranging from cancer-specific outcomes to quality-of-life outcomes are being investigated. The inclusion criteria in these trials also varied in terms of volume of metastatic disease (oligometastatic to high-volume metastatic disease), diagnosis of metastases (imaging based vs biopsy confirmed), imaging modalities used (conventional to newer modalities), as well as outcomes and follow-up regimes.
While there are differences in each protocol, each trial aims to address different aspects of CRP in de novo HSPC. Therefore, the specific goals of each study and the limitations have to be taken into consideration when interpreting the results of these trials.
综述新诊断激素敏感性转移性前列腺癌（HSPC）去势前列腺切除术（CRP）的正在进行的随机试验，以确定其目标，并评估其优缺点。
通过 PubMed、MEDLINE 和临床试验网站搜索，确定了新诊断为 HSPC 的 CRP 正在进行的临床试验。
确定了 9 项 CRP 的随机临床试验，包括：西南肿瘤协作组（SWOG）1802 研究、前列腺癌转移的手术治疗（SIMCAP）、转移性前列腺癌局部肿瘤辅助治疗：新型治疗方案评估（IP2-ATLANTA）、检测局限性骨转移前列腺癌患者根治性前列腺切除术（TRoMbone）、局限性骨转移前列腺癌患者根治性前列腺切除术作为初始治疗的影响（g-RAMPP）、去势前列腺切除术与去势前列腺放疗作为转移性前列腺癌局部治疗选择：多中心可行性试验（LoMP II）、雄激素剥夺治疗或雄激素剥夺治疗加确定性治疗（放疗或手术）（FUSCC-OMPCa）、中国局限性骨转移前列腺癌患者根治性前列腺切除术研究。每项研究都不同，评估了各种主要结局指标，包括总生存期（OS）、无进展生存期和在标准治疗与 CRP 或放疗与 CRP 之间随机分配的可行性，在寡转移环境中，试验评估 OS、随机分配的可行性和去势抵抗时间。同样，也在研究从癌症特异性结局到生活质量结局等一系列次要终点。这些试验的纳入标准在转移疾病的体积（寡转移到高体积转移）、转移的诊断（基于影像学与活检证实）、使用的影像学方式（传统与新型）以及结局和随访方案方面也有所不同。
尽管每个方案都存在差异，但每项试验都旨在解决新诊断 HSPC 中 CRP 的不同方面。因此，在解释这些试验的结果时，必须考虑到每项研究的具体目标和局限性。
