攝護腺動脈栓塞治療於攝護腺疾之註冊臨床研究初步分析

盧致誠^1,2  林憲雄^１ 林嘉禾^１ 邱毅平^１ 王脩仁^１ 范文宙^１ 鄭哲舟^１

^１奇美醫療財團法人柳營奇美醫院 外科部 泌尿外科

^２國立中正大學　資訊管理研究所

Preliminary Analysis of Registered Clinical Trials for Prostatic Artery Embolization in Prostate Disease

Chih-Cheng Lu^1,2, Chian-Shiung Lin¹,Chia-Ho Lin¹, Yi-Ping Chiu¹, Hsiu-Jen Wang¹ , Wen-Chou Fan¹, Tse-Chou Cheng¹

^１Division of Urology, Department of Surgery, Chi Mei Medical Center, Liouying, Tainan

²Department of Information Management, National Chung Cheng University, Chiayi

Purpose:

Although evolving techniques of prostate disease treatment were appealing, no all effectiveness was convincing. Prostatic artery embolization (PAE) for prostate disease is our focus on the clinical standpoint. This is a study to explore the latest clinical trials for PAE.

Materials and Methods:

A secondary data analysis was used in the study. Data was collected and assessed from the website of clinicaltrials.gov. The search keywords were prostate artery embolization.

Results:

There were forty-five registered clinical trials on line up to April, 2022. A total 41 out of 45 registered trials was for benign prostate hyperplasia and the other for prostate cancer. Phase I, II, and III trials were found in the individual registered trial. The earliest study was a comparison study between PAE and transurethral resection of prostate (TURP) for benign prostatic hyperplasia (BPH) in April, 2013. In the 45 trials, there were 5 withdrawn due to no case enrollment, and 13 completed.  In the 13 completed trails, 11 were for BPH and the others for prostate cancer. There were totally about 600 participants including comparison or control groups in the 11 trials. The largest enrollment (318) was done in the United Kingdom and the improvement was not sustainable due to high re-intervention rate. The United States was the most frequent regions for registered PAE study. In addition to United Kingdom, France, Canada, Spain, Denmark, Italy, Norway, and Switzerland, Taiwan was also a site for PAE trials which was led by urological specialty. Most of principal investigators of the trials were radiologist or urologist, and no cardiologist was noted.

Conclusions:

PAE for prostate benign or malignant prostate disease in selected patients is evolving. However, high level of evidence or strong recommendations are not well established. A long term study is warranted.