Nuclear Medicine Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):87-94. doi: 10.1007/s00259-020-04914-8. Epub 2020 Jun 26.
To evaluate the clinical value of Ga-PSMA PET/CT negativity in patients with biochemical recurrent prostate cancer (BCR).
One hundred three BCR patients (median age, 70 years; median PSA, 0.47 ng/mL) with negative Ga-PSMA PET/CT, followed up for at least 1 year, were retrospectively identified in a database of 1003 consecutive patients undergoing Ga-PSMA PET/CT for BCR. Clinical recurrence (CR) was determined or excluded on follow-up imaging selected as per clinical practice. Clinical recurrence-free survival (CRFS) was computed from the date of negative Ga-PSMA PET/CT to the date of evident disease; frequencies of CRFS were described as per ISUP patient subset (subset 1: ISUP grades 1 and 2; subset 2: ISUP grade 3; subset 3: ISUP grades 4 and 5) and other conventional variables.
In 57 patients out of 103 (55.3%), CR was detected in the prostatic fossa (45.6%), nodes (38.6%), and bone (15.8%). The median CRFS was 15.4 months (range, 12.1-20.5), with a CRFS at 12 months in 61.4% of cases (range, 50.9-70.4) whereas the 24-month CRFS was 34.8% (range, 24-45.8). ISUP subset 1 benefited from significantly longer CRFS compared to subset 2 and subset 3 (median CRFS, 20.5 months, 12.6 months, and 12.1 months, respectively). ISUP subset 3 had significantly poorer 24-month CRFS (9.3%) compared to subset 1 (47.8%) and subset 2 (33.5%). At the univariate and multivariate analyses, the ISUP subset was the only significant risk factor for clinical relapse; ISUP subset 3 and subset 2 patients held a higher risk of CR compared to subset 1 patients (HR of 2.75 [1.35-5.57] for subset 3 versus subset 1; HR of 2.08 [1.11-3.88] for subset 2 versus subset 1).
Ga-PSMA PET/CT negativity in early BCR patients (PSA < 0.5 ng/mL) with low-grade primary prostate cancer (ISUP1 and 2) may support the exploration of a clinical surveillance approach in future prospective studies.
评估 Ga-PSMA PET/CT 阴性在生化复发前列腺癌（BCR）患者中的临床价值。
在我们数据库中，共 1003 例连续接受 Ga-PSMA PET/CT 检查的 BCR 患者中，回顾性地确定了 103 例 BCR 患者（中位年龄 70 岁；中位 PSA 0.47ng/mL）的 Ga-PSMA PET/CT 检查为阴性，并至少随访 1 年。临床复发（CR）是根据临床实践选择的随访影像学检查来确定或排除的。从 Ga-PSMA PET/CT 阴性日期到出现疾病的日期计算临床无复发生存（CRFS）；根据 ISUP 患者亚组（亚组 1：ISUP 分级 1 和 2；亚组 2：ISUP 分级 3；亚组 3：ISUP 分级 4 和 5）和其他常规变量描述 CRFS 的频率。
在 103 例患者中的 57 例（55.3%）中，在前列腺窝（45.6%）、淋巴结（38.6%）和骨骼（15.8%）中检测到 CR。中位 CRFS 为 15.4 个月（范围 12.1-20.5），12 个月时 CRFS 为 61.4%（范围 50.9-70.4%），而 24 个月时 CRFS 为 34.8%（范围 24-45.8%）。与亚组 2 和亚组 3相比，ISUP 亚组 1 的 CRFS 显著更长（中位 CRFS，分别为 20.5 个月、12.6 个月和 12.1 个月）。ISUP 亚组 3 的 24 个月 CRFS 明显较差（9.3%），低于亚组 1（47.8%）和亚组 2（33.5%）。在单因素和多因素分析中，ISUP 亚组是临床复发的唯一显著危险因素；与亚组 1 相比，ISUP 亚组 3 和亚组 2 患者的 CR 风险更高（亚组 3 与亚组 1 相比，HR 为 2.75[1.35-5.57]；亚组 2 与亚组 1 相比，HR 为 2.08[1.11-3.88]）。
在早期 BCR 患者（PSA<0.5ng/mL）中，Ga-PSMA PET/CT 阴性且原发性前列腺癌分级较低（ISUP1 和 2）可能支持在未来的前瞻性研究中探索临床监测方法。
