Gongora Magdalena, Stranne Johan, Johansson Eva, Bottai Matteo, Thellenberg Karlsson Camilla, Brasso Klaus, Hansen Steinbjørn, Jakobsen Henrik, Jäderling Fredrik, Lindberg Henriette, Lilleby Wolfgang, Meidahl Petersen Peter, Mirtti Tuomas, Olsson Mats, Rannikko Antti, Røder Martin Andreas, Henrik Vincent Per, Akre Olof
Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden.
Eur Urol Open Sci. 2022 May 26;41:63-73. doi: 10.1016/j.euros.2022.04.013. eCollection 2022 Jul.
There is no high-grade evidence for surgery as primary treatment for locally advanced prostate cancer. The SPCG-15 study is the first randomized trial comparing surgical treatment with radiotherapy.
To describe the baseline characteristics of the first 600 randomized men in the SPCG-15 study. The study will compare mortality and functional outcomes.
This study is a Scandinavian prospective, open, multicenter phase III randomized clinical trial aiming to randomize 1200 men.
Radical prostatectomy with or without consecutive radiotherapy (experimental) and radiotherapy with neoadjuvant androgen deprivation therapy (standard of care).
Cause-specific survival, metastasis-free survival, overall survival, and patient-reported bowel function, sexual health, and lower urinary tract symptoms were measured.
The distribution of characteristics was similar in the two study arms. The median age was 67 yr (range 45-75 yr). Among the operated men, 36% had pT3a stage of disease and 39% had pT3b stage. grades 2, 3, 4, and 5 were prevalent in 21%, 35%, 7%, and 27%, respectively. Half of the men (51%) in the surgery arm had no positive lymph nodes. The main limitation is the pragmatic design comparing the best available practice at each study site leading to heterogeneity of treatment regimens within the study arms.
We have proved that randomization between surgery and radiotherapy for locally advanced prostate cancer is feasible. The characteristics of the study population demonstrate a high prevalence of advanced disease, well-balanced comparison groups, and a demography mirroring the Scandinavian population of men with prostate cancer at large.
This study, which has recruited >600 men, compares radiotherapy with surgery for prostate cancer, and an analysis at the time of randomization indicates that the study will be informative and generalizable to most men with locally advanced but not metastasized prostate cancer.
对于局部晚期前列腺癌，尚无高级别证据支持手术作为主要治疗方法。SPCG - 15研究是首个比较手术治疗与放疗的随机试验。
描述SPCG - 15研究中前600名随机分组男性的基线特征。该研究将比较死亡率和功能结局。
设计、地点和参与者：本研究是一项斯堪的纳维亚前瞻性、开放性、多中心III期随机临床试验，旨在将1200名男性随机分组。
行或不行连续放疗的根治性前列腺切除术（试验组）以及新辅助雄激素剥夺治疗的放疗（对照标准）。
测量特定病因生存率、无转移生存率、总生存率以及患者报告的肠道功能、性健康和下尿路症状。
两个研究组的特征分布相似。中位年龄为67岁（范围45 - 75岁）。接受手术的男性中，36%为pT3a期疾病，39%为pT3b期。2级、3级、4级和5级分别占21%、35%、7%和27%。手术组一半的男性（51%）没有阳性淋巴结。主要局限性是采用实用设计比较各研究地点的最佳现有治疗方法，导致研究组内治疗方案存在异质性。
我们已证明局部晚期前列腺癌手术与放疗之间的随机分组是可行的。研究人群的特征表明晚期疾病患病率高、比较组均衡，且人口统计学特征反映了斯堪的纳维亚广大前列腺癌男性人群。
本研究招募了600多名男性，比较前列腺癌放疗与手术，随机分组时的分析表明该研究将为大多数局部晚期但未转移的前列腺癌男性提供信息且具有普遍性。
