一项前瞻性II期试验:18F-Flotufolastat (rhPSMA-7.3) PET/CT利尿改善前列腺切除术后复发检测

Ismaheel O. Lawal, Aliza Mushtaq, Ashesh B. Jani, Manali Rupji, Vishal R. Dhere, Sagar A. Patel, Mehmet A. Bilen, Pretesh R. Patel, Nikhil T. Sebastian, Jeffrey M. Switchenko, David M. Schuster, Charles Marcus
{"title":"一项前瞻性II期试验:18F-Flotufolastat (rhPSMA-7.3) PET/CT利尿改善前列腺切除术后复发检测","authors":"Ismaheel O. Lawal, Aliza Mushtaq, Ashesh B. Jani, Manali Rupji, Vishal R. Dhere, Sagar A. Patel, Mehmet A. Bilen, Pretesh R. Patel, Nikhil T. Sebastian, Jeffrey M. Switchenko, David M. Schuster, Charles Marcus","doi":"10.2967/jnumed.124.268574","DOIUrl":null,"url":null,"abstract":"<p>Radiopharmaceuticals targeting prostate-specific membrane antigen (PSMA) have emerged as a sensitive tool for PET imaging of prostate cancer (PCa) recurrence. Yet urinary bladder activity may obscure the visualization of prostate bed recurrence. Among the Food and Drug Administration–approved PSMA radiopharmaceuticals, <sup>18</sup>F-flotufolastat (rhPSMA-7.3) has the lowest urinary excreted activity. We investigated the impact of diuresis with intravenous furosemide and oral hydration on bladder activity and PCa recurrence detection in patients with PCa after prostatectomy with biochemical recurrence. <strong>Methods:</strong> This phase II study (NCT05779943) prospectively recruited men with PCa after prostatectomy with a rising prostate-specific antigen (PSA) level of at least 0.1 ng/mL. All patients had 2 <sup>18</sup>F-flotufolastat PET/CT scans, one with 20 mg of furosemide administered intravenously with the radiotracer and the other without. SUV<sub>mean</sub>, SUV<sub>max</sub>, and bladder volume were compared between the with- and without-furosemide PET/CT studies. PCa lesion detection was compared between the 2 sets of scans. <strong>Results:</strong> Twenty men with a median PSA of 0.61 ng/mL (interquartile range, 0.18–1.15) completed both sets of scans. Bladder activity was significantly lower for the with- than the without-furosemide studies, at a median SUV<sub>max</sub> of 4.20 (range, 1.70–19.80) versus 13.35 (range, 3.90–165.4), respectively (<em>P</em> = 0.014), and a median SUV<sub>mean</sub> of 2.95 (range, 0.80–17.60) versus 10.00 (range, 1.90–140.00), respectively (<em>P</em> = 0.017). Multivariable analysis demonstrated that both furosemide administration and bladder distention were independent covariates for reduced bladder activity. At the prostate bed region level, the recurrence detection rates were 17 of 20 (85%) and 12 of 20 (60%) for the with- and without-furosemide studies, respectively (<em>P</em> = 0.025). No difference in detection rates was present at the per-patient, pelvic, or extrapelvic regions between the 2 sets of studies. Three of 20 without-furosemide studies had a mild noninterfering peribladder halo artifact, but none had an artifact with furosemide. <strong>Conclusion:</strong> In men with biochemical recurrence and a PSA level of at least 0.1 ng/mL after prostatectomy for PCa, a strategy with <sup>18</sup>F-flotufolastat PET/CT and concordant low-dose furosemide further reduces urinary bladder intensity and increases local recurrence detection. Even without the use of a diuretic, relative bladder distension alone also reduces bladder activity, though not to the same degree as with a diuretic.</p>","PeriodicalId":22820,"journal":{"name":"The Journal of Nuclear Medicine","volume":"25 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Diuresis During 18F-Flotufolastat (rhPSMA-7.3) PET/CT Improves Recurrence Detection After Prostatectomy: A Prospective Phase II Trial\",\"authors\":\"Ismaheel O. Lawal, Aliza Mushtaq, Ashesh B. Jani, Manali Rupji, Vishal R. Dhere, Sagar A. Patel, Mehmet A. Bilen, Pretesh R. Patel, Nikhil T. Sebastian, Jeffrey M. Switchenko, David M. Schuster, Charles Marcus\",\"doi\":\"10.2967/jnumed.124.268574\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>Radiopharmaceuticals targeting prostate-specific membrane antigen (PSMA) have emerged as a sensitive tool for PET imaging of prostate cancer (PCa) recurrence. Yet urinary bladder activity may obscure the visualization of prostate bed recurrence. Among the Food and Drug Administration–approved PSMA radiopharmaceuticals, <sup>18</sup>F-flotufolastat (rhPSMA-7.3) has the lowest urinary excreted activity. We investigated the impact of diuresis with intravenous furosemide and oral hydration on bladder activity and PCa recurrence detection in patients with PCa after prostatectomy with biochemical recurrence. <strong>Methods:</strong> This phase II study (NCT05779943) prospectively recruited men with PCa after prostatectomy with a rising prostate-specific antigen (PSA) level of at least 0.1 ng/mL. All patients had 2 <sup>18</sup>F-flotufolastat PET/CT scans, one with 20 mg of furosemide administered intravenously with the radiotracer and the other without. SUV<sub>mean</sub>, SUV<sub>max</sub>, and bladder volume were compared between the with- and without-furosemide PET/CT studies. PCa lesion detection was compared between the 2 sets of scans. <strong>Results:</strong> Twenty men with a median PSA of 0.61 ng/mL (interquartile range, 0.18–1.15) completed both sets of scans. Bladder activity was significantly lower for the with- than the without-furosemide studies, at a median SUV<sub>max</sub> of 4.20 (range, 1.70–19.80) versus 13.35 (range, 3.90–165.4), respectively (<em>P</em> = 0.014), and a median SUV<sub>mean</sub> of 2.95 (range, 0.80–17.60) versus 10.00 (range, 1.90–140.00), respectively (<em>P</em> = 0.017). Multivariable analysis demonstrated that both furosemide administration and bladder distention were independent covariates for reduced bladder activity. At the prostate bed region level, the recurrence detection rates were 17 of 20 (85%) and 12 of 20 (60%) for the with- and without-furosemide studies, respectively (<em>P</em> = 0.025). No difference in detection rates was present at the per-patient, pelvic, or extrapelvic regions between the 2 sets of studies. Three of 20 without-furosemide studies had a mild noninterfering peribladder halo artifact, but none had an artifact with furosemide. <strong>Conclusion:</strong> In men with biochemical recurrence and a PSA level of at least 0.1 ng/mL after prostatectomy for PCa, a strategy with <sup>18</sup>F-flotufolastat PET/CT and concordant low-dose furosemide further reduces urinary bladder intensity and increases local recurrence detection. Even without the use of a diuretic, relative bladder distension alone also reduces bladder activity, though not to the same degree as with a diuretic.</p>\",\"PeriodicalId\":22820,\"journal\":{\"name\":\"The Journal of Nuclear Medicine\",\"volume\":\"25 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-01-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Journal of Nuclear Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2967/jnumed.124.268574\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Journal of Nuclear Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2967/jnumed.124.268574","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

针对前列腺特异性膜抗原(PSMA)的放射性药物已成为前列腺癌(PCa)复发的PET成像的敏感工具。然而,膀胱活动可能模糊前列腺床复发的可视化。在美国食品和药物管理局批准的PSMA放射性药物中,18F-flotufolastat (rhPSMA-7.3)的尿排泄活性最低。我们研究了利尿加静脉速尿和口服水化对前列腺切除术后生化复发的前列腺癌患者膀胱活动和前列腺癌复发检测的影响。方法:这项II期研究(NCT05779943)前瞻性招募前列腺切除术后前列腺特异性抗原(PSA)水平升高至少0.1 ng/mL的前列腺癌患者。所有患者都进行了2次18F-flotufolastat PET/CT扫描,其中一名患者静脉注射了20mg呋塞米并给予放射性示踪剂,另一名患者没有。比较使用和不使用速尿的PET/CT研究的SUVmean、SUVmax和膀胱体积。比较两组扫描的前列腺癌病变检出率。结果:20名中位PSA为0.61 ng/mL(四分位数范围0.18-1.15)的男性完成了两组扫描。服用呋塞米组膀胱活动明显低于未服用呋塞米组,SUVmax中位数分别为4.20(1.70-19.80)和13.35 (3.90-165.4)(P = 0.014), SUVmax中位数分别为2.95(0.80-17.60)和10.00 (1.90-140.00)(P = 0.017)。多变量分析表明,速尿给药和膀胱膨胀是膀胱活动减少的独立协变量。在前列腺床区水平上,使用和不使用速尿组的复发检出率分别为17 / 20(85%)和12 / 20 (60%)(P = 0.025)。两组研究在单个患者、盆腔或盆腔外区域的检出率没有差异。20项未使用速尿的研究中有3项有轻度无干扰性膀胱周围晕影,但没有一例使用速尿时出现晕影。结论:对于前列腺癌前列腺切除术后生化复发且PSA水平≥0.1 ng/mL的男性,18f - flofolastat PET/CT联合低剂量速尿可进一步降低膀胱强度,增加局部复发检出率。即使不使用利尿剂,单独的相对膀胱膨胀也会减少膀胱活动,尽管程度与利尿剂不同。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Diuresis During 18F-Flotufolastat (rhPSMA-7.3) PET/CT Improves Recurrence Detection After Prostatectomy: A Prospective Phase II Trial

Radiopharmaceuticals targeting prostate-specific membrane antigen (PSMA) have emerged as a sensitive tool for PET imaging of prostate cancer (PCa) recurrence. Yet urinary bladder activity may obscure the visualization of prostate bed recurrence. Among the Food and Drug Administration–approved PSMA radiopharmaceuticals, 18F-flotufolastat (rhPSMA-7.3) has the lowest urinary excreted activity. We investigated the impact of diuresis with intravenous furosemide and oral hydration on bladder activity and PCa recurrence detection in patients with PCa after prostatectomy with biochemical recurrence. Methods: This phase II study (NCT05779943) prospectively recruited men with PCa after prostatectomy with a rising prostate-specific antigen (PSA) level of at least 0.1 ng/mL. All patients had 2 18F-flotufolastat PET/CT scans, one with 20 mg of furosemide administered intravenously with the radiotracer and the other without. SUVmean, SUVmax, and bladder volume were compared between the with- and without-furosemide PET/CT studies. PCa lesion detection was compared between the 2 sets of scans. Results: Twenty men with a median PSA of 0.61 ng/mL (interquartile range, 0.18–1.15) completed both sets of scans. Bladder activity was significantly lower for the with- than the without-furosemide studies, at a median SUVmax of 4.20 (range, 1.70–19.80) versus 13.35 (range, 3.90–165.4), respectively (P = 0.014), and a median SUVmean of 2.95 (range, 0.80–17.60) versus 10.00 (range, 1.90–140.00), respectively (P = 0.017). Multivariable analysis demonstrated that both furosemide administration and bladder distention were independent covariates for reduced bladder activity. At the prostate bed region level, the recurrence detection rates were 17 of 20 (85%) and 12 of 20 (60%) for the with- and without-furosemide studies, respectively (P = 0.025). No difference in detection rates was present at the per-patient, pelvic, or extrapelvic regions between the 2 sets of studies. Three of 20 without-furosemide studies had a mild noninterfering peribladder halo artifact, but none had an artifact with furosemide. Conclusion: In men with biochemical recurrence and a PSA level of at least 0.1 ng/mL after prostatectomy for PCa, a strategy with 18F-flotufolastat PET/CT and concordant low-dose furosemide further reduces urinary bladder intensity and increases local recurrence detection. Even without the use of a diuretic, relative bladder distension alone also reduces bladder activity, though not to the same degree as with a diuretic.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信