Comparison of PET/CT-based eligibility according to VISION and TheraP trial criteria in end-stage prostate cancer patients undergoing radioligand therapy.

IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Annals of Nuclear Medicine Pub Date : 2024-02-01 Epub Date: 2023-10-27 DOI:10.1007/s12149-023-01874-5
Kerstin Michalski, Aleksander Kosmala, Rudolf A Werner, Sebastian E Serfling, Anna K Seitz, Constantin Lapa, Andreas K Buck, Philipp E Hartrampf
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Abstract

Background: Two randomized clinical trials demonstrated the efficacy of prostate-specific membrane antigen (PSMA) radioligand therapy (PSMA RLT) in metastatic castration-resistant prostate cancer (mCRPC). While the VISION trial used criteria within PSMA PET/CT for inclusion, the TheraP trial used dual tracer imaging including FDG PET/CT. Therefore, we investigated whether the application of the VISION criteria leads to a benefit in overall survival (OS) or progression-free survival (PFS) for men with mCRPC after PSMA RLT.

Methods: Thirty-five men with mCRPC who had received PSMA RLT as a last-line option and who had undergone pretherapeutic imaging with FDG and [68Ga]Ga-PSMA I&T or [18F]PSMA-1007 were studied. Therapeutic eligibility was retrospectively evaluated using the VISION and TheraP study criteria.

Results: 26 of 35 (74%) treated patients fulfilled the VISION criteria (= VISION+) and only 17 of 35 (49%) fulfilled the TheraP criteria (= TheraP+). Significantly reduced OS and PFS after PSMA RLT was observed in patients rated VISION- compared to VISION+ (OS: VISION-: 3 vs. VISION+: 12 months, hazard ratio (HR) 3.1, 95% confidence interval (CI) 1.0-9.1, p < 0.01; PFS: VISION-: 1 vs. VISION+: 5 months, HR 2.7, 95% CI 1.0-7.8, p < 0.01). For patients rated TheraP-, no significant difference in OS but in PFS was observed compared to TheraP+ patients (OS: TheraP-: 5.5 vs. TheraP+: 11 months, HR 1.6, 95% CI 0.8-3.3, p = 0.2; PFS: TheraP-: 1 vs. TheraP+: 6 months, HR 2.2, 95% CI 1.0-4.5, p < 0.01).

Conclusion: Retrospective application of the inclusion criteria of the VISION study leads to a benefit in OS and PFS after PSMA RL, whereas TheraP criteria appear to be too strict in patients with end-stage prostate cancer. Thus, performing PSMA PET/CT including a contrast-enhanced CT as proposed in the VISION trial might be sufficient for treatment eligibility of end-stage prostate cancer patients.

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根据VISION和TheraP试验标准,接受放射性配体治疗的终末期前列腺癌症患者基于PET/CT的资格比较。
背景:两项随机临床试验证明了前列腺特异性膜抗原(PSMA)放射性配体治疗(PSMA RLT)对转移性去势耐受性癌症(mCRPC)的疗效。VISION试验使用PSMA PET/CT中的标准进行纳入,而TheraP试验使用包括FDG PET/CT在内的双示踪剂成像。因此,我们研究了VISION标准的应用是否有利于PSMA RLT后mCRPC患者的总生存期(OS)或无进展生存期(PFS)。方法:对35名mCRPC患者进行研究,他们接受了PSMA RLT作为最后一行选择,并接受了FDG和[68Ga]Ga-PSMA I&T或[18F]PSMA-1007的治疗前成像。使用VISION和TheraP研究标准对治疗资格进行回顾性评估。结果:35名接受治疗的患者中有26名(74%)符合VISION标准(= VISION+),35人中只有17人(49%)符合TheraP标准(= TheraP+)。与VISION+相比,VISION-评分患者PSMA RLT后OS和PFS显著降低(OS:VISION-:3 vs.VISION+:12个月,危险比(HR)3.1,95%置信区间(CI)1.0-9.1,p 结论:回顾性应用VISION研究的纳入标准可使PSMA RL后OS和PFS受益,而TheraP标准在终末期前列腺癌症患者中似乎过于严格。因此,进行包括VISION试验中建议的对比增强CT在内的PSMA PET/CT可能足以满足终末期前列腺癌症患者的治疗资格。
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来源期刊
Annals of Nuclear Medicine
Annals of Nuclear Medicine 医学-核医学
CiteScore
4.90
自引率
7.70%
发文量
111
审稿时长
4-8 weeks
期刊介绍: Annals of Nuclear Medicine is an official journal of the Japanese Society of Nuclear Medicine. It develops the appropriate application of radioactive substances and stable nuclides in the field of medicine. The journal promotes the exchange of ideas and information and research in nuclear medicine and includes the medical application of radionuclides and related subjects. It presents original articles, short communications, reviews and letters to the editor.
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