Abstract：
OBJECTIVE: Next-line systemic treatment (NEST) is the standard of care for patients presenting with progressive metastatic castration-resistant prostate cancer (mCRPC). Progression-directed therapy (PDT), defined as a lesion-directed approach in patients with a limited number of progressive and/or new lesions, could postpone the need for NEST in these patients with so-called oligoprogressive mCRPC. Our aim was to investigate the feasibility of postponing NEST initiation in oligoprogressive mCRPC by using PDT.
METHODS: MEDCARE was a prospective, single-arm, nonrandomized phase 2 trial. Eligible patients had oligoprogressive mCRPC and were treated with PDT while their ongoing systemic therapy was continued. The primary endpoint was NEST-free survival (NEST-FS). Secondary endpoints were prostate-specific antigen response, clinical progression-free survival (cPFS), prostate cancer-specific survival (PCSS), overall survival (OS), and PDT-induced toxicity.
UNASSIGNED: Twenty patients underwent PDT for 38 oligoprogressive lesions. At median follow-up of 28 mo, median NEST-FS was 17 mo and the 2-yr NEST-FS rate was 35%. Median PCSS and median OS were not reached. The PCSS and OS rates at 2 yr were 80% and 70%, respectively. The 2-yr local control rate was 95%. No patient experienced early or late grade ≥3 toxicity. NEST-FS was longer for patients who received PDT to all lesions visible on 18F-PSMA positron emission tomography/computed tomography (30 vs 13 mo; p = 0.002).
CONCLUSIONS: This single-center, single-arm, phase 2 trial demonstrated that PDT in oligoprogressive mCRPC resulted in median NEST-FS of 17 mo without any early or late grade ≥3 toxicity.
RESULTS: For patients with metastatic prostate cancer no longer responding to hormone therapy, we investigated radiotherapy targeted at progressive cancer lesions while continuing their ongoing systemic treatment. The results show that this targeted therapy had very low toxicity and delayed the need to start a new line of systemic treatment by 17 months.
METHODS: MEDCARE was a prospective, single-arm, nonrandomized phase 2 trial. Eligible patients had oligoprogressive mCRPC and were treated with PDT while their ongoing systemic therapy was continued. The primary endpoint was NEST-free survival (NEST-FS). Secondary endpoints were prostate-specific antigen response, clinical progression-free survival (cPFS), prostate cancer-specific survival (PCSS), overall survival (OS), and PDT-induced toxicity.
UNASSIGNED: Twenty patients underwent PDT for 38 oligoprogressive lesions. At median follow-up of 28 mo, median NEST-FS was 17 mo and the 2-yr NEST-FS rate was 35%. Median PCSS and median OS were not reached. The PCSS and OS rates at 2 yr were 80% and 70%, respectively. The 2-yr local control rate was 95%. No patient experienced early or late grade ≥3 toxicity. NEST-FS was longer for patients who received PDT to all lesions visible on 18F-PSMA positron emission tomography/computed tomography (30 vs 13 mo; p = 0.002).
CONCLUSIONS: This single-center, single-arm, phase 2 trial demonstrated that PDT in oligoprogressive mCRPC resulted in median NEST-FS of 17 mo without any early or late grade ≥3 toxicity.
RESULTS: For patients with metastatic prostate cancer no longer responding to hormone therapy, we investigated radiotherapy targeted at progressive cancer lesions while continuing their ongoing systemic treatment. The results show that this targeted therapy had very low toxicity and delayed the need to start a new line of systemic treatment by 17 months.
摘要：
目的：对于进展性转移性去势抵抗性前列腺癌（mCRPC）患者，下线全身治疗（NEST）是标准治疗。进展导向治疗（PDT），定义为进展性和/或新病变数量有限的患者的病变导向方法，可能会推迟这些所谓的寡进行性mCRPC患者对NEST的需求。我们的目的是研究通过使用PDT在寡进mCRPC中推迟NEST启动的可行性。
方法：MEDCARE是一种前瞻性的，单臂,非随机2期试验。符合条件的患者患有寡进行性mCRPC，并在继续进行全身治疗的同时接受PDT治疗。主要终点是无NEST生存期（NEST-FS）。次要终点是前列腺特异性抗原反应，临床无进展生存期（cPFS），前列腺癌特异性生存率（PCSS），总生存期（OS），和PDT诱导的毒性。
■20例患者因38例慢进性病变接受PDT治疗。在中位随访28个月时，NEST-FS中位数为17个月，2年NEST-FS率为35%。未达到中位PCSS和中位OS。2年的PCSS和OS率分别为80%和70%，分别。2年局部控制率为95%。没有患者出现早期或晚期≥3级毒性。对于在18F-PSMA正电子发射断层扫描/计算机断层扫描上可见的所有病变接受PDT的患者，NEST-FS更长（30对13个月；p=0.002）。
结论：这种单中心，单臂,2期试验表明,低聚进行性mCRPC的PDT导致中位NEST-FS为17个月,无任何早期或晚期≥3级毒性.
结果：对于转移性前列腺癌患者不再对激素治疗有反应，我们调查了针对进展性癌病灶的放疗,同时继续其正在进行的全身治疗.结果表明，这种靶向治疗具有非常低的毒性，并将开始新的全身治疗线的需要推迟了17个月。
方法：MEDCARE是一种前瞻性的，单臂,非随机2期试验。符合条件的患者患有寡进行性mCRPC，并在继续进行全身治疗的同时接受PDT治疗。主要终点是无NEST生存期（NEST-FS）。次要终点是前列腺特异性抗原反应，临床无进展生存期（cPFS），前列腺癌特异性生存率（PCSS），总生存期（OS），和PDT诱导的毒性。
■20例患者因38例慢进性病变接受PDT治疗。在中位随访28个月时，NEST-FS中位数为17个月，2年NEST-FS率为35%。未达到中位PCSS和中位OS。2年的PCSS和OS率分别为80%和70%，分别。2年局部控制率为95%。没有患者出现早期或晚期≥3级毒性。对于在18F-PSMA正电子发射断层扫描/计算机断层扫描上可见的所有病变接受PDT的患者，NEST-FS更长（30对13个月；p=0.002）。
结论：这种单中心，单臂,2期试验表明,低聚进行性mCRPC的PDT导致中位NEST-FS为17个月,无任何早期或晚期≥3级毒性.
结果：对于转移性前列腺癌患者不再对激素治疗有反应，我们调查了针对进展性癌病灶的放疗,同时继续其正在进行的全身治疗.结果表明，这种靶向治疗具有非常低的毒性，并将开始新的全身治疗线的需要推迟了17个月。
