MRI引导的经尿道超声消融（TULSA）在长期控制前列腺癌方面有效：5年时PSA中值降低90%

宋宝林医生

MRI引导的经尿道超声消融（TULSA）在长期控制前列腺癌方面有效：5年时，PSA中值降低了90%。

华盛顿 -- TACT关键试验的长期随访结果显示，MRI引导的经尿道超声消融（TULSA）在治疗局限性前列腺癌的男性中是有效且持久的。

在芝加哥大学的Scott Eggener博士在泌尿学肿瘤学会年会上报告说，5年时前列腺特异性抗原（PSA）水平的中值为0.63 ng/mL，比基线时的中值降低了90%。

5年时的生化复发无事件生存率和总生存率分别为86%和99%。

Eggener告诉MedPage Today：“对于许多男性来说，从肿瘤学和功能性角度看，这些结果是持久的。显然随着时间的推移，会有患者在癌症方面出现问题，但副作用的情况基本上是维持不变的，需要接受挽救治疗的患者比率相对较低。”

Eggener强调，该研究评估了TULSA作为整个腺体疗法的效果，"但现在正在对局部治疗的人进行评估、提供和应用。"

TULSA使用超声波在实时MRI指导下热凝固组织。来自闭环MRI温度计的反馈自动控制治疗参数，以匹配处方消融体积中的组织反应。

Eggener及其同事指出：“虽然这项关键研究代表了使用TULSA的早期经验，但通过现代协议可以减轻失败的风险。这些协议包括筛查可能导致治疗不足的前列腺内钙化物的最佳实践、设备定位策略的改进以及热剂量升级以应对程序内成像可见的治疗不足。”

在5年时，92%的患者恢复了无垫片的排尿控制，87%保持了足以进行性交的勃起功能。

Eggener说：“从一开始，关于排尿控制的数据就非常强劲。”至于勃起功能数据，他指出，虽然大多数男性保持了他们的基线勃起功能，但在将TULSA作为整个腺体疗法应用的这项试验中，有一部分男性会出现新的勃起功能障碍，需要药物或其他干预。

他指出：“但关键是要报告这一点，并在与患者交流时强调，TULSA目前主要作为局部治疗应用。因此，按照定义，当它作为局部治疗应用时，勃起功能障碍的发生率将远低于整个腺体疗法报告的比率。”

Eggener表示，受TACT启发的CAPTAIN III期随机对照试验正在招募中，该试验将根治性前列腺切除术与局部TULSA进行比较。

他补充说：“强调这是整个腺体治疗，关于腺体减小和PSA的早期迹象远远超出了我们对主要终点的预期。最终，我们将从与标准护理的直接比较中获得最佳数据。”

II期TACT研究在五个国家的13个地点进行，包括115名器官局限性前列腺癌患者，他们接受了一次保留前列腺尿道和尿道括约肌的整个腺体TULSA治疗。

该研究在1年时显示了有效的组织消融和PSA减少，以及低毒性和残留疾病的低发生率。

在基线时，患者的中位年龄为65岁，PSA中位数为6.3 ng/mL。大多数男性（72个中的115个）患有≥2级疾病。其中25名男性接受了挽救治疗：10名接受前列腺切除术，11名接受放疗，3名接受雄激素剥夺治疗，1名接受手术并接受放疗，均未出现意外并发症。

在安全性方面，没有发生≥4级不良事件（AEs）、直肠损伤或瘘管。9名男性在1年内出现并解决了3级AEs，在第二年出现并解决了两名男性的AEs，包括泌尿生殖道感染、狭窄、潴留、尿道结石、疼痛、尿液瘤和下尿路症状。
（翻译仅供参考）

原文链接：https://www.medpagetoday.com/meetingcoverage/suo/107680
原文：
TULSA Effective in Controlling Prostate Cancer Long-Term— At 5 years, median PSA was reduced by 90%。
WASHINGTON -- Results from a long-term follow-up of the pivotal TACT trial showed that MRI-guided transurethral ultrasound ablation (TULSA) was effective and durable in men with localized prostate cancer.

The median prostate-specific antigen (PSA) level at 5 years was 0.63 ng/mL -- a 90% reduction from the median PSA at baseline, reported Scott Eggener, MD, of the University of Chicago, during the Society of Urologic Oncologyopens in a new tab or window annual meeting.

Biochemical recurrence-free survival and overall survival rates at 5 years were 86% and 99%, respectively.

"For many men, the results oncologically and functionally are durable," Eggener told MedPage Today. "Obviously with more time, there are going to be patients who fall off from a cancer standpoint, but the side effect profile is more or less maintained, and there are some patients who required salvage therapy, but that rate was relatively low."

Eggener emphasized that the study evaluated TULSA as whole-gland therapy, "but is now being evaluated, offered, and applied for people with focal therapy."

TULSA uses ultrasound to thermally coagulate tissue under real-time MRI guidance. Feedback from closed-loop MRI thermometry automatically controls treatment parameters to match tissue response in the prescribed ablation volume.

"While the pivotal study represents early experience with TULSA, the risk of failure is mitigated by modern protocols," Eggener and colleagues noted. "Such protocols include best practices for screening for intraprostatic calcifications that can lead to undertreatment, refined strategies for device positioning, and thermal dose escalation to address undertreatment that is visible on intraprocedural imaging."

At 5 years, 92% of patients recovered pad-free continence, and 87% preserved erections sufficient for penetration.

"The continence data from the very beginning has been very strong," Eggener said. As for the erectile function data, he pointed out that while the majority of men maintained their baseline erections, there is a subset of men when TULSA is applied as whole-gland therapy -- as it was in this trial -- who will have new erectile dysfunction requiring medications or other interventions.

"But the key piece for reporting it and for talking to patients is that TULSA is largely being applied as focal therapy now," he pointed out. "So, by definition when it is applied as focal therapy, there is an extraordinarily high likelihood that the rates of erectile dysfunction will be lower than reported for whole-gland therapy."

Eggener said that the ongoing randomized phase III CAPTAIN trialopens in a new tab or window of radical prostatectomy versus focal TULSA, which was informed by TACT, is enrolling.

"Emphasizing that it was whole-gland therapy, the early signs as far as gland decrease and PSA went above and beyond the expectations for our primary endpoint," he added. "Ultimately, where we're going to get the best data is head-to-head against standard of care."

The phase II TACT studyopens in a new tab or window took place across 13 sites in five countries and included 115 men with organ-confined prostate cancer who underwent a single whole-gland TULSA treatment that spared the prostatic urethra and urinary sphincter.

Results from the study at 1 yearopens in a new tab or window showed effective tissue ablation and PSA reductions, with low rates of toxicity and residual disease.

At baseline, patients' median age was 65, and median PSA was 6.3 ng/mL. Most of the men (72 0f 115) had ≥Grade Group 2 disease. Of the included men, 25 had received salvage treatment: 10 underwent prostatectomy, 11 received radiotherapy, three received androgen deprivation therapy, and one underwent surgery and received radiation, all without unexpected complications.

As for safety, there were no grade ≥4 adverse events (AEs), rectal injury, or fistula. Grade 3 AEs occurred in nine men with resolution before 1 year, and in two men with onset and resolution in the second year, including genitourinary infection, stricture, retention, urethral calculi, pain, urinoma, and lower urinary tract symptoms.