Department of Radiology, Aarhus University Hospital, Aarhus, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
BJU Int. 2021 Dec;128(6):702-712. doi: 10.1111/bju.15443. Epub 2021 Jun 17.
To investigate whether a risk score for prostate cancer (PCa) lifetime risk can be used to optimise triaging of patients with a negative prostate biopsy, but under sustained suspicion of PCa.
In this prospective clinical study, we included, and risk scored patients who had a PCa-negative transrectal ultrasonography (TRUS)-guided prostate biopsy, but elevated prostate-specific antigen (PSA), a suspicious prostate digital rectal examination and/or a positive family history (FH) of PCa. The risk score estimated individual lifetime risk of PCa, based on a polygenic risk score (33 single nucleotide polymorphisms), age, and FH of PCa. Patients were followed, under urological supervision, for up to 4 years with annual controls, always including PSA measurements. Multiparametric magnetic resonance imaging (mpMRI) and/or prostate biopsy was performed at selected annual controls depending on risk score and at the urologist's/patient's discretion, which means that the follow-up differed based on the risk score.
We included 429 patients. After risk scoring, 376/429 (88%) patients were allocated to a normal-risk group (<30% PCa lifetime risk) and 53/429 (12%) to a high-risk group (≥30% PCa lifetime risk). The high-risk group had significantly different follow-up, with more biopsy and mpMRI sessions compared to the normal-risk group. PCa was detected in 89/429 (21%) patients, with 67/376 (18%) patients diagnosed in the normal-risk group and 22/53 (42%) in the high-risk group. There was no statistically significant difference in the cumulative incidence of PCa between the normal-risk group and the high-risk group after 4 years of follow-up. Currently, 67/429 (16%) patients are still being followed in this ongoing study.
In a 4-year perspective, our PCa lifetime risk score did not demonstrate significant prognostic value for triaging patients, with a negative TRUS-guided biopsy and sustained suspicion of PCa.
探讨前列腺癌（PCa）终生风险评分是否可用于优化前列腺活检阴性但持续怀疑 PCa 的患者的分诊。
在这项前瞻性临床研究中，我们纳入了前列腺特异性抗原（PSA）升高、前列腺数字直肠检查可疑和/或 PCa 家族史阳性的经直肠超声（TRUS）引导下前列腺活检阴性的患者，并对其进行风险评分。该风险评分基于多基因风险评分（33 个单核苷酸多态性）、年龄和 PCa 家族史，估计个体 PCa 的终生风险。患者在泌尿科监督下随访 4 年，每年进行一次控制，始终包括 PSA 测量。根据风险评分和泌尿科医生/患者的决定，每年在选择的控制中进行多参数磁共振成像（mpMRI）和/或前列腺活检，这意味着随访基于风险评分而有所不同。
我们纳入了 429 名患者。经过风险评分后，376/429（88%）名患者被分配到低危组（<30%PCa 终生风险），53/429（12%）名患者被分配到高危组（≥30%PCa 终生风险）。高危组的随访明显不同，活检和 mpMRI 次数明显多于低危组。429 名患者中，89/429（21%）名患者检测到 PCa，其中 376/376（18%）名患者在低危组中诊断，53/53（100%）名患者在高危组中诊断。在 4 年的随访后，低危组和高危组的 PCa 累积发生率没有统计学差异。目前，这项正在进行的研究中仍有 67/429（16%）名患者在随访中。
在 4 年的时间里，我们的 PCa 终生风险评分对于经 TRUS 引导的活检阴性且持续怀疑 PCa 的患者的分诊并没有显示出显著的预后价值。
