Division of Urology, McMaster University, Hamilton, ON, Canada.
Int Braz J Urol. 2018 Mar-Apr;44(2):248-257. doi: 10.1590/S1677-5538.IBJU.2017.0025.
Some men with localized radio-recurrent prostate cancer may benefit from salvage high-intensity focused ultrasound (HIFU). Herein, we describe oncologic outcomes and predictors of disease response after salvage whole gland HIFU from our prospective cohort.
Patients with localized radio-recurrent prostate cancer were prospectively enrolled from January 2005 to December 2014. Participants had to meet both biochemical and histological definitions of recurrence. Exclusion criteria included the receipt of prior salvage therapy, presence of metastatic disease, and administration of ADT in the 6-months prior to enrollment. Participants were treated with a single session of whole-gland HIFU ablation with the AblathermTM device (EDAP, France). The primary endpoint was recurrence-free survival (RFS), defined as a composite endpoint of PSA progression (Phoenix criteria), receipt of any further salvage therapy, receipt of ADT, clinical progression, or death. Kaplan-Meier survival analysis was used to determine the primary end-point and stratifications were used to determine the significance of 6 pre-specified predictors of improved RFS (TRUS biopsy grade, number of study entry TRUS biopsy cores positive, palpable disease at study enrollment, pre-HIFU PSA, an undetectable post-HIFU PSA nadir, and receipt of prior hormone therapy). Survival analysis was performed on participants with a minimum of 1-year follow-up.
Twenty-four participants were eligible for study inclusion with a median follow-up of 31.0 months. Median PSA at study entry was 4.02ng/ml. Median time to PSA nadir was 3 months after treatment and median post-HIFU PSA nadir was 0.04ng/ ml. Median 2-year and 5-year RFS was 66.3% and 51.6% respectively. Of our 6 pre-specified predictors, an undetectable PSA nadir was the only significant predictor of improved RFS (HR 0.07, 95% CI 0.02-0.29, log-rank P<0.001). One participant underwent an intervention for a urethral stricture. No participants developed osteitis pubis or rectourethral fistulae.
Salvage HIFU allows for disease control in selected patients with localized radio-recurrent prostate cancer. An undetectable PSA nadir serves as an early predictor of disease response.
对于局部放射性复发性前列腺癌患者，挽救性高强度聚焦超声（HIFU）可能有益。在此，我们描述了从我们的前瞻性队列中进行挽救性全腺体 HIFU 后的肿瘤学结果和疾病反应的预测因素。
2005 年 1 月至 2014 年 12 月，前瞻性招募了局部放射性复发性前列腺癌患者。参与者必须同时满足生化和组织学定义的复发。排除标准包括接受过挽救性治疗、存在转移性疾病以及在入组前 6 个月内接受 ADT。参与者接受单次全腺体 HIFU 消融治疗，使用 AblathermTM 设备（EDAP，法国）。主要终点是无复发生存率（RFS），定义为 PSA 进展（凤凰标准）、任何进一步挽救性治疗、ADT 治疗、临床进展或死亡的复合终点。使用 Kaplan-Meier 生存分析来确定主要终点，并进行分层以确定 6 个预先指定的改善 RFS 预测因素的意义（TRUS 活检分级、研究入组时 TRUS 活检阳性核心数量、研究入组时可触及疾病、治疗前 PSA、治疗后 PSA 不可检测的最低点和接受过激素治疗）。对至少有 1 年随访的参与者进行生存分析。
24 名参与者符合研究纳入标准，中位随访时间为 31.0 个月。研究入组时 PSA 中位数为 4.02ng/ml。PSA 最低点中位数时间为治疗后 3 个月，治疗后 PSA 最低点中位数为 0.04ng/ml。中位 2 年和 5 年 RFS 分别为 66.3%和 51.6%。在我们的 6 个预先指定的预测因素中，PSA 最低点不可检测是唯一显著改善 RFS 的预测因素（HR 0.07，95%CI 0.02-0.29，对数秩 P<0.001）。1 名参与者因尿道狭窄而行介入治疗。没有参与者发生耻骨骨炎或直肠尿道瘘。
挽救性 HIFU 可使局部放射性复发性前列腺癌患者的疾病得到控制。PSA 最低点不可检测可作为疾病反应的早期预测因素。
