Background:This interventional pilot study aimed to evaluate the short-term (3 years) efficacy of focal laser ablation (FLA) in treating the index lesion of low–intermediate-risk prostate cancer, along with assessing the safety of the procedure (ClinicalTrials.gov ID NCT04045756).Methods:Forty patients aged between 46 and 86 with histologically proven organ-confined prostate cancer and low-to-intermediate progression risk were included. FLA was performed under percutaneous fusion magnetic resonance/ultrasound guidance in a Day Hospital setting under local anesthesia. Patients underwent regular clinical and functional assessments through the international index of erectile function (IIEF-5) and the International Prostatism Symptom Score (IPSS), PSA measurements, post-procedure MRI scans, and biopsies at 36 months or if positive findings were detected earlier. Statistical analyses were conducted to assess trends in PSA levels and cavity dimensions over time.Results:Forty patients were initially included, with fifteen lost to follow-up. At 36 months, a mean PSA reduction of 60% was observed, and 80% of MRI scans showed no signs of in-field clinically significant residual/recurrent cancer. Biopsies at 36 months revealed no malignant findings in 20 patients. No deterioration in sexual function or urinary symptoms was recorded.Conclusions:FLA appears to be safe, feasible, and effective in the index lesion treatment of low–intermediate-risk prostate cancer, with a high rate of tumor eradication and preservation of quality of life.
背景：本项介入性先导研究旨在评估局灶性激光消融术治疗中低风险前列腺癌指征病灶的短期（3年）疗效，并评估该手术的安全性（临床试验注册号NCT04045756）。 方法：研究纳入40例年龄46至86岁、经组织学证实为器官局限性前列腺癌且进展风险为中低度的患者。所有患者均在日间病房局部麻醉下，经皮磁共振/超声融合引导完成局灶性激光消融术。术后通过国际勃起功能指数问卷、国际前列腺症状评分量表、前列腺特异性抗原检测、术后磁共振成像扫描进行规律临床及功能评估，并在36个月或更早出现阳性发现时进行穿刺活检。通过统计分析评估前列腺特异性抗原水平及消融腔隙尺寸随时间的变化趋势。 结果：研究初期纳入的40例患者中，15例失访。36个月随访数据显示，患者前列腺特异性抗原平均降低60%，80%的磁共振成像扫描未见术野内存在临床显著性残留/复发癌灶。20例患者36个月时的穿刺活检结果未发现恶性证据。研究期间未记录到性功能或泌尿系统症状的恶化。 结论：局灶性激光消融术治疗中低风险前列腺癌指征病灶具有安全性、可行性和有效性，在实现较高肿瘤清除率的同时能有效维持患者生活质量。
Transperineal Laser Ablation (TPLA) Treatment of Focal Low–Intermediate Risk Prostate Cancer
肿瘤(癌症)患者之家