Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.
Department of Nuclear Medicine, University Hospital of Ulm, Ulm, Germany.
Radiat Oncol. 2018 Jun 18;13(1):113. doi: 10.1186/s13014-018-1057-3.
The goal of this study is to evaluate the status and future perspectives of clinical trials on positron emission tomography in prostate cancer for diagnostic or therapeutic as well as for surveillance purposes.
The www.ClinicalTrials.gov database was searched on the 20th of January 2017 for all trials containing terms describing "prostate cancer" (prostate, prostatic, malignant, malignancy, cancer, tumor) and "positron emission tomography". In total 167 trials were identified. Trials that included diseases other than PCa were excluded (n = 27; 16%). Furthermore, we excluded trials (n = 4, 2%) withdrawn prior to first patient enrollment. The remaining trials (n = 137, 82%) were selected for further manual classification analysis.
One hundred thirty-seven trials were detected and analyzed. Majority of trials were in "active" recruitment status (n = 46, 34%) followed by trials that had been "completed" - (n = 34, 25%) and trials with "closed recruitment but active follow-up" (n = 23, 17%). Phase 1 and 2 comprised 46% of the complete trial portfolio. Locally confined disease was of major interest (n = 46, 34%), followed by metastatic disease - not otherwise specified (n = 43, 13%). Evaluation of PET was the primary goal of the trial in 114 (83%) cases. Most of the trials evaluated only one agent (n = 122, 89%). Choline and PSMA represented two major groups (total 50%) and they were equally distributed across trial portfolio with 25% (n = 34) each. PSMA trials showed the highest average annual growth rate of 56%. The trials were conducted in 17 countries.
The scientific community is showing a strong and ever-growing interest in the field and we expect that in the coming years, more phase III trials will be initiated ultimately delivering the required Level 1 evidence.
本研究旨在评估前列腺癌正电子发射断层扫描（PET）的临床试验现状和未来前景，包括诊断、治疗和监测目的。
于 2017 年 1 月 20 日在 www.ClinicalTrials.gov 数据库中检索所有包含描述“前列腺癌”（前列腺、前列腺的、恶性、恶性肿瘤、癌症、肿瘤）和“正电子发射断层扫描”的术语的试验。共确定了 167 项试验。排除了包含除 PCa 以外疾病的试验（n=27；16%）。此外，我们还排除了在首次入组前撤回的试验（n=4，2%）。其余的试验（n=137，82%）被选为进一步的手动分类分析。
共检测到并分析了 137 项试验。大多数试验处于“活跃”招募状态（n=46，34%），其次是已“完成”的试验（n=34，25%）和“已关闭招募但仍在积极随访”的试验（n=23，17%）。1 期和 2 期试验占完整试验组合的 46%。局限性疾病是主要关注点（n=46，34%），其次是未特指的转移性疾病（n=43，13%）。评估 PET 是 114 项试验（83%）的主要目标。大多数试验仅评估一种药物（n=122，89%）。胆碱和 PSMA 代表两个主要的组别（总共 50%），在试验组合中分布均匀，各占 25%（n=34）。PSMA 试验的年平均增长率最高，为 56%。这些试验在 17 个国家进行。
科学界对这一领域表现出强烈且不断增长的兴趣，我们预计在未来几年内，将启动更多的 III 期试验，最终提供所需的 1 级证据。
