医学
前列腺癌
谷氨酸羧肽酶Ⅱ
放射科
多参数磁共振成像
淋巴结
活检
放射治疗
解剖(医学)
泌尿科
放射治疗计划
肿瘤科
前列腺
超声波
临床研究阶段
直肠检查
阶段(地层学)
内科学
随机对照试验
多塔
癌症
临床试验
外科
组织病理学
前列腺特异性抗原
磁共振成像
作者
Philipp Krausewitz,Markus Essler,Florian Gaertner,Ulrike Attenberger,Julian A. Luetkens,Glen Kristiansen,Marit Bernhardt,Carsten‐Henning Ohlmann,M. Anspach,Matthias Schmid,Robert Németh,Jennifer Schmitz,Stefan Hauser,Jörg Ellinger,Manuel Ritter
标识
DOI:10.2967/jnumed.125.271344
摘要
68Ga-PSMA-11 PET/CT (PSMA PET/CT) is used for staging advanced prostate cancer (PCa); however, its role in initial cancer detection and guiding localized treatment remains uncertain. The primary objective of this study was to assess the impact of upfront PSMA PET/CT on treatment decision-making based on imaging and biopsy-derived information. Methods: In this prospective, phase 2 interventional trial, 230 biopsy- and imaging-naïve men with suspected PCa underwent PSMA PET/CT and multiparametric MRI (mpMRI) before targeted ultrasound fusion and systematic biopsy. Randomized assessor teams independently reviewed histopathology and imaging data from either the mpMRI or the combined mpMRI plus PSMA PET/CT pathway and formulated treatment plans accordingly. Patient recruitment was conducted between 2021 and 2023. Results: Among 137 patients with PCa (9% low-, 35% intermediate-, and 15% high-risk disease), PSMA PET/CT altered management plans in 34% of patients, primarily modifying local treatment strategies, including lymph node dissection (16%), a nerve-sparing procedure (18%), and radiation field adjustments (28%). Systemic therapy escalation was rare (1%). In addition, 2% of patients initiated active treatment, 5% received adjunctive hormone therapy, and 7% underwent metastasis-directed therapy. Upfront PSMA PET/CT prompted treatment intensification at comparable rates in both intermediate-risk (31%) and high-risk (30%) PCa with high interrater agreement (Cohen κ, 0.71; 95% CI, 0.61–0.80). Prostate-specific antigen density of at least 0.15 ng/mL3 (odds ratio, 2.48; 95% CI, 1.22–5.06) and abnormal digital rectal examination (odds ratio, 2.12; 95% CI, 1.03–4.33) predicted PSMA PET/CT–driven changes. Conclusion: Early PSMA PET/CT staging altered treatment strategies for up to one third of patients with intermediate- and high-risk PCa by enhancing metastasis detection and local tumor characterization. Its effect on oncologic and functional outcomes warrants further investigation.
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