Division of Urology, Department of Surgery, Fondazione Policlinico Tor Vergata, University of Tor Vergata, Rome, Italy.
Urol Oncol. 2012 Sep;30(5):577-83. doi: 10.1016/j.urolonc.2010.08.019. Epub 2011 Feb 2.
To test high-intensity focused ultrasound (HIFU) as salvage first-line treatment for palpable, TRUS-evidenced, biopsy-proven locally recurrent prostate cancer (CaP) after radical prostatectomy (RP).
Nineteen patients with palpable, TRUS-evidenced, biopsy-proven local recurrence of CaP after RP, unwilling to undergo salvage radiotherapy (SRT), underwent HIFU as a single-session procedure. Pre-, intra-, and postoperative data including early and late complications, and oncologic outcomes (PSA nadir, biochemical recurrence (BCR)-free survival, and need of secondary adjuvant treatment) were prospectively evaluated. Success was defined as PSA nadir ≤0.1 ng/ml obtained within 3 months from HIFU. In case of PSA nadir >0.1 ng/ml or PSA increase ≥1 ng/ml above the PSA nadir, a biopsy of the treated lesion was performed, and if negative, maximum androgen blockade (MAB) was adopted. In case of positive biopsy, RT was performed. Failure was defined as use of secondary adjuvant treatment (MAB or RT).
Median follow-up was 48 months. All cases were performed as overnight procedure. No case of urethrorectal fistula or anastomotic stricture was observed. Two cases of acute urinary retention were resolved with prolonged urethral catheterization. Four cases of stress urinary incontinence were observed; 2 (mild incontinence) were resolved after pelvic floor exercises within 6 months, while 2 cases of severe incontinence required surgical minimally invasive treatment;17/19 patients (89,5%) were classified as success. Two patients failed to show a PSA nadir <0.1 ng/ml. During follow-up, 8/17 patients (47%) were classified as failure, with consequent total rate of failures 10/19 (52.6%). A statistically significant difference was observed in pre-HIFU median PSA (2 vs. 5.45 ng/ml, respectively, P = 0.013) and Gleason score of the RP specimen (P = 0.01) between the success and failure group.
Salvage first-line HIFU for palpable, TRUS-evidenced, biopsy-proven local recurrence of CaP is a feasible, minimally invasive day-case procedure, with an acceptable morbidity profile. It seems to have a good cancer control in the short- and mid-term. Patients with lower pre-HIFU PSA level and favorable pathologic Gleason score presented better oncologic outcomes. A prospective randomized trial with an adequate recruitment and follow-up is necessary to confirm our preliminary oncologic results.
探讨高强度聚焦超声（HIFU）作为挽救性一线治疗在根治性前列腺切除术后局部复发前列腺癌（CaP）的应用，该术式适用于触诊可及、经直肠超声（TRUS）证实、经活检证实的局部复发 CaP 患者，且这些患者不愿意接受挽救性放疗（SRT）。
19 例局部复发的 CaP 患者在根治性前列腺切除术后触诊、TRUS 证实和经活检证实，他们不愿意接受挽救性放疗（SRT），仅接受 HIFU 作为单一疗程的治疗。前瞻性评估包括术前、术中、术后数据，包括早期和晚期并发症以及肿瘤学结果（PSA 最低值、生化复发（BCR）无复发生存率和需要辅助治疗）。成功定义为 HIFU 治疗后 3 个月内 PSA 最低值≤0.1ng/ml。如果 PSA 最低值>0.1ng/ml 或 PSA 增加≥1ng/ml 以上，则对治疗部位进行活检，如果活检阴性，则采用最大雄激素阻断（MAB）。如果活检阳性，则进行放疗。如果需要辅助治疗（MAB 或 RT）则定义为失败。
中位随访时间为 48 个月。所有病例均在夜间完成，无尿道直肠瘘或吻合口狭窄。2 例急性尿潴留经延长导尿得到解决。4 例出现压力性尿失禁，2 例（轻度尿失禁）在 6 个月内通过盆底锻炼得到解决，2 例严重尿失禁需要微创手术治疗。19 例患者中有 17 例（89.5%）被归类为成功。2 例患者 PSA 最低值未<0.1ng/ml。随访期间，17 例患者中有 8 例（47%）被归类为失败，总失败率为 10/19（52.6%）。成功组和失败组之间的 HIFU 治疗前中位 PSA（分别为 2ng/ml 和 5.45ng/ml，P=0.013）和前列腺切除标本 Gleason 评分（P=0.01）有显著差异。
对于触诊可及、TRUS 证实、经活检证实的局部复发 CaP，HIFU 作为挽救性一线治疗是一种可行的、微创的日间手术，具有可接受的发病率。它似乎在短期和中期具有良好的肿瘤控制效果。HIFU 治疗前 PSA 水平较低和病理 Gleason 评分较好的患者具有更好的肿瘤学结果。需要一项前瞻性随机试验，以确保足够的招募和随访来证实我们的初步肿瘤学结果。
