骨扫描指数在前列腺癌骨转移预后及治疗效果中的作用：多中心前列腺癌骨扫描指数标准激素与化疗登记研究（PROSTAT - BSI）的研究设计与原理

Role of bone scan index in the prognosis and effects of therapy on prostate cancer with bone metastasis: Study design and rationale for the multicenter Prostatic Cancer Registry of Standard Hormonal and Chemotherapy Using Bone Scan Index (PROSTAT-BSI) study.

作者信息

Nakajima Kenichi, Kaneko Go, Takahashi Satoru, Matsuyama Hideyasu, Shiina Hiroaki, Ichikawa Tomohiko, Horikoshi Hiroyuki, Hashine Katsuyoshi, Sugiyama Yutaka, Miyao Takeshi, Kamiyama Manabu, Harada Kenichi, Ito Akito, Mizokami Atsushi

机构信息

Department of Nuclear Medicine, Kanazawa University Hospital, Kanazawa, Japan.

Department of Uro-Oncology, Saitama Medical University International Medical Center, Saitama, Japan.

出版信息

Int J Urol. 2018 May;25(5):492-499. doi: 10.1111/iju.13556. Epub 2018 Apr 6.

DOI:10.1111/iju.13556

PMID:29633398

Abstract

OBJECTIVE

To present the study design and rationale of Prostatic Cancer Registry of Standard Hormonal and Chemotherapy Using Bone Scan Index, a prospective study aiming to determine the role of the bone scan index, the amount of bone metastasis, in the treatment and prognosis of prostate cancer patients.

METHODS

A total of 237 patients were recruited at 30 hospitals in Japan. All had prostate cancer with bone metastasis and were scheduled to undergo either hormonal therapy (group H) or chemotherapy (group C). Bone scans were carried out with Tc-methylenediphosphonate. Follow-up studies are planned to continue for 3 years, and changes in biochemical and tumor markers in response to hormonal therapy and chemotherapy will be recorded in addition to skeletal-related events, recurrence, disease progression and death.

RESULTS

The basic characteristics of the patients (n = 200) at the time of registration during December 2016 were as follows: mean age 71 ± 8 years; median bone scan index calculated on-site 1.9% (range 0.02-13.3%); median number of hot spots 18 (range 1-128); median prostate-specific antigen 155 ng/mL (range 0.04-22 412 ng/mL); and the most frequent Gleason score 9 (47%). The prostate-specific antigen value was higher in group H than group C (288 vs 33 ng/mL, P < 0.0001), whereas bone scan indexes were comparable (1.7 vs 2.3%, not significant) between the two groups. Liver metastasis was more frequent in group C than group H (6.1% vs 0.8%, P = 0.035).

CONCLUSIONS

The baseline characteristics of the Prostatic Cancer Registry of Standard Hormonal and Chemotherapy Using Bone Scan Index database have been established. This collaborative study can now proceed with clarifying the role of the bone scan index for patient management including treatment strategies and prognosis.

摘要

目的

介绍使用骨扫描指数的前列腺癌标准激素和化疗登记研究的设计和基本原理，这是一项前瞻性研究，旨在确定骨扫描指数（骨转移量）在前列腺癌患者治疗和预后中的作用。

方法

在日本的30家医院共招募了237名患者。所有患者均患有前列腺癌并伴有骨转移，且计划接受激素治疗（H组）或化疗（C组）。采用锝-亚甲基二膦酸盐进行骨扫描。计划随访3年，除记录骨骼相关事件、复发、疾病进展和死亡情况外，还将记录激素治疗和化疗后生化及肿瘤标志物的变化。

结果

2016年12月登记时患者（n = 200）的基本特征如下：平均年龄71±8岁；现场计算的骨扫描指数中位数为1.9%（范围0.02 - 13.3%）；热点数量中位数为18个（范围1 - 128）；前列腺特异性抗原中位数为155 ng/mL（范围0.04 - 22412 ng/mL）；最常见的Gleason评分为9分（47%）。H组的前列腺特异性抗原值高于C组（288 vs 33 ng/mL，P < 0.0001），而两组的骨扫描指数相当（1.7 vs 2.3%，无显著性差异）。C组的肝转移比H组更常见（6.1% vs 0.8%，P = 0.035）。