Hölscher Tobias, Baumann Michael, Kotzerke Jörg, Zöphel Klaus, Paulsen Frank, Müller Arndt-Christian, Zips Daniel, Koi Lydia, Thomas Christian, Löck Steffen, Krause Mechthild, Wirth Manfred, Lohaus Fabian
Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany; National Center for Tumor Diseases (NCT), Partner Site Dresden, Dresden, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
German Cancer Research Center (DKFZ), Heidelberg, Germany; OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden - Rossendorf, Dresden, Germany.
Eur Urol Oncol. 2022 Feb;5(1):44-51. doi: 10.1016/j.euo.2021.10.002. Epub 2021 Nov 14.
Local ablative radiotherapy (aRT) of oligometastatic prostate cancer (PCa) is very promising and has become a focus of current clinical research.
We hypothesize that aRT is safe and effective in gallium-68 prostate-specific membrane antigen targeted positron emission tomography (PSMA-PET)-staged oligometastatic PCa patients.
DESIGN, SETTING, AND PARTICIPANTS: A nonrandomized, prospective, investigator-initiated phase 2 trial recruited patients with oligometastatic PCa (five or fewer lymph node or osseous metastases) after local curative therapy, without significant comorbidity and androgen deprivation therapy (ADT), at two German centers from 2014 to 2018.
All PSMA-PET-positive metastases were treated with aRT. No systemic therapy was initiated.
The primary endpoint was treatment-related toxicity (grade ≥2) 24 mo after aRT. A one-sided single-sample test of proportions was planned to test whether the endpoint occurs in <15% of the patients. Key secondary endpoints were time to progression of prostate-specific antigen (PSA) and time to ADT, which were associated with potential prognostic factors by Cox regression.
Of 72 patients, 63 received aRT (13% dropout rate). The median follow-up was 37.2 mo. No treatment-related grade ≥2 toxicity was observed 2 yr after treatment. The median time to PSA progression and time to ADT were 13.2 and 20.6 mo, respectively. Of the patients, 21.4% were free of PSA progression after 3 yr.
It was observed that aRT is safe, and midterm PSA progression and ADT-free time were achieved in one of five patients. Randomized clinical trials are indicated to further evaluate the option of delaying ADT in selected patients.
In this clinical trial, 63 patients with up to five metastases of prostate cancer without androgen deprivation therapy were included. We showed that local ablative radiotherapy is safe and that one in five patients had no recurrent prostate-specific antigen value after 3 yr. Local ablative radiotherapy might be an option to avoid systemic therapy in selected patients.
寡转移前列腺癌（PCa）的局部消融放疗（aRT）前景广阔，已成为当前临床研究的焦点。
我们假设aRT在镓68前列腺特异性膜抗原靶向正电子发射断层扫描（PSMA-PET）分期的寡转移PCa患者中是安全有效的。
设计、设置和参与者：一项非随机、前瞻性、研究者发起的2期试验，于2014年至2018年在德国两个中心招募局部根治性治疗后患有寡转移PCa（淋巴结或骨转移灶不超过5个）、无显著合并症且未接受雄激素剥夺治疗（ADT）的患者。
所有PSMA-PET阳性转移灶均接受aRT治疗。未启动全身治疗。
主要终点是放疗后24个月的治疗相关毒性（≥2级）。计划进行单侧单样本比例检验，以检验终点是否在<15%的患者中出现。关键次要终点是前列腺特异性抗原（PSA）进展时间和开始ADT的时间，通过Cox回归分析它们与潜在预后因素的相关性。
72例患者中，63例接受了aRT治疗（脱落率13%）。中位随访时间为37.2个月。治疗后2年未观察到治疗相关的≥2级毒性。PSA进展的中位时间和开始ADT的时间分别为13.2个月和20.6个月。3年后，21.4%的患者无PSA进展。
观察到aRT是安全的，五分之一的患者实现了中期PSA进展和无ADT时间。需要进行随机临床试验以进一步评估在选定患者中延迟ADT的选择。
在这项临床试验中，纳入了63例不超过5个转移灶且未接受雄激素剥夺治疗的前列腺癌患者。我们表明局部消融放疗是安全的，五分之一的患者在3年后前列腺特异性抗原值未复发。局部消融放疗可能是选定患者避免全身治疗的一种选择。
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