背景:前列腺特异性膜抗原(PSMA)正电子发射断层扫描/计算机断层扫描(PET/CT)正在成为前列腺癌生化复发(BCR)男性的护理标准。该人群中PSMAPET/CT扫描阴性的含义尚不清楚。这项研究旨在评估前列腺癌根治术(RP)后复发时[18F]DCFPyLPET/CT扫描阴性的BCR患者的预后。
方法:这是一项前瞻性非随机临床试验的事后亚组分析。一百一十一名患者(平均年龄,75年)在RP后使用BCR,在[18F]DCFPyLPET/CT上测试为阴性,随后接受了有或没有雄激素剥夺治疗(ADT)的挽救性放疗(sRT)或没有积极治疗的随访,包括在内。根据临床实践选择的随访影像学确定PSMAPET/CT阴性后的进展自由(FFP)。进行了单因素和多因素Cox回归分析,以检查患者特征的相关性,肿瘤特异性变量,并在最后一次随访时进行临床进展的治疗。FFP在1-,2-,使用KaplanMeier分析报告3年。
结果:PET/CT的PSA中位数为0.56ng/mL(范围,0.4-11.3)。65(64%)患者在没有接受进一步治疗的情况下进行了随访,在PSMAPET的3个月内,36例(36%)接受了sRT(仅18%到前列腺床,18%到前列腺床和盆腔淋巴结)。17例sRT患者(36例中的17例,47%)接受了伴随的雄激素剥夺治疗(ADT)。中位随访时间为39个月。在21例患者(21%)中检测到随后的临床进展,盆腔淋巴结占52%,52%在前列腺窝,19%在远处淋巴结,14%在肺部,和10%的骨头。12个月时FFP为95%(95%CI:91%-99%),24个月时为87%(95%CI:81%-94%),36个月时为79%(95%CI:71%-88%)。多变量Cox回归分析显示,最初的国际泌尿外科病理学会(ISUP)5级与最后一次随访时的临床进展显着相关(风险比,5.1,P值,0.04).此外,在最后一次随访时,接受sRT与较低的临床进展显着相关(风险比,0.2,P值,0.03),而其他临床和肿瘤特异性参数则没有。在仅监测和sRT之后,29%(65例中的19例)和6%(36例中的2例)的患者,分别,显示临床进展。在sRT组中,接受前列腺窝sRT的患者与接受前列腺窝和盆腔淋巴结sRT的患者之间的FFP没有显着差异,尽管这些组中的数字很小。
结论:这项研究表明,对于PSMAPET/CT扫描结果阴性的前列腺癌根治术后生化复发患者,挽救性放疗与临床进展减少或延迟相关。该分析还强调了初始ISUP分级的预后意义,ISUP5级与较差的结果相关。
背景:2016年9月14日注册;NCT02899312。
BACKGROUND: Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) is becoming standard of care for men with biochemical recurrence (BCR) of prostate cancer. The implications of a negative PSMA PET/CT scan in this population remain unclear. This study aims to assess the outcome of patients with BCR post radical prostatectomy (RP) who have negative [18F]DCFPyL PET/CT scan at relapse.
METHODS: This is a post-hoc subgroup analysis of a prospective non randomized clinical trial. One hundred and one patients (median age, 75 years) with BCR after RP, who tested negative on [18F]DCFPyL PET/CT and subsequently either underwent salvage radiotherapy (sRT) with or without androgen deprivation therapy (ADT) or were followed without active treatment, were included. Freedom from progression (FFP) after negative PSMA PET/CT was determined based on follow-up imaging selected as per clinical practice. Uni- and multivariate Cox regression analyses were performed to examine the association of patients\' characteristics, tumor-specific variables, and treatment with clinical progression at the last follow-up. FFP at 1-, 2-, and 3-year were reported using Kaplan Meier analysis.
RESULTS: The median PSA level at PET/CT was 0.56 ng/mL (range, 0.4-11.3). Sixty five (64%) patients were followed without receiving further treatment, and 36 (36%) received sRT (18% to the prostate bed only and 18% to the prostate bed and pelvic lymph nodes) within 3 months of the PSMA PET. Seventeen of the sRT patients (17 of 36, 47%) received concomitant androgen deprivation therapy (ADT). Median follow-up was 39 months. Subsequent clinical progression was detected in 21 patients (21%), with 52% in pelvic lymph nodes, 52% in the prostatic fossa, 19% in distant lymph nodes, 14% in lungs, and 10% in bones. The FFP was 95% (95% CI: 91%-99%) at 12 months, 87% (95% CI: 81%-94%) at 24 months, and 79% (95% CI: 71%-88%) at 36 months. Multivariate Cox regression analysis revealed that an initial International Society of Urological Pathology (ISUP) grade 5 was significantly associated with clinical progression at the last follow-up (hazard ratio, 5.1, P value, 0.04). Furthermore, the receipt of sRT correlated significantly with lower clinical progression at the last follow-up (hazard ratio, 0.2, P value, 0.03), whereas other clinical and tumor-specific parameters did not. Following surveillance-only and sRT, 29% (19 of 65) and 6% (2 of 36) of patients, respectively, showed clinical progression. In the sRT group, no significant difference was observed in FFP between patients who underwent sRT to the prostatic fossa versus those who received sRT to the prostatic fossa and pelvic lymph nodes, although the numbers in these groups were small.
CONCLUSIONS: This study suggests that salvage radiotherapy is associated with a decreased or delayed clinical progression in patients with biochemical recurrence following radical prostatectomy who have negative PSMA PET/CT scan results. The analysis also underscores the prognostic significance of the initial ISUP grade, with ISUP grade 5 being associated with worse outcomes.
BACKGROUND: Registered September 14, 2016; NCT02899312 .