Sherif Ramadan, Andrew Loblaw, Aneesh Dhar, Hatim Fakir, Lucas C Mendez, Andrew Warner, Matt Wronski, John Conyngham, Zahra Kassam, Vibhuti Kalia, Vivian S Tan, Priscila Crivellaro, Aaron D Ward, Jonathan Thiessen, Ting-Yim Lee, David Laidley, Glenn S Bauman
{"title":"PSMA MRI引导前列腺SABR argos -攀援者I/II期试验：主要终点分析。","authors":"Sherif Ramadan, Andrew Loblaw, Aneesh Dhar, Hatim Fakir, Lucas C Mendez, Andrew Warner, Matt Wronski, John Conyngham, Zahra Kassam, Vibhuti Kalia, Vivian S Tan, Priscila Crivellaro, Aaron D Ward, Jonathan Thiessen, Ting-Yim Lee, David Laidley, Glenn S Bauman","doi":"10.1016/j.ijrobp.2025.04.039","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>The XXXXX trial is a multi-institutional phase I/II study utilizing a combined PSMA PET/MRI approach to treat dominant intraprostatic lesions (DILs) and affected lymph nodes in unfavorable intermediate and high-risk prostate cancer using a five fraction SABR and simultaneous in-field boost (SIB) technique. Here we report on the primary endpoint of toxicity within 6 months of treatment.</p><p><strong>Methods and materials: </strong>SIB volumes were defined utilizing a PET/MRI acquired using 18F-PSMA 1007. Five fraction SABR was planned to deliver doses (maximum SIB) to prostate 35 Gy (50 Gy), SV 25 Gy (50 Gy) and lymph nodes 25 Gy (35 Gy) while respecting OAR's. Toxicity and QOL were assessed according to CTCAE 5.0 and EPIC-26 during radiation, at 6 weeks post-treatment and at 6 months post treatment.</p><p><strong>Results: </strong>In total 50 patients were treated, 23 patients had unfavorable intermediate risk disease, 23 were high risk, and 4 were very high-risk prostate cancer. Median prostate SIB of 41.6 Gy (IQR: 39.3-44.8 Gy) was delivered to a median of 1 intra-prostatic lesion. Eighteen patients received nodal treatment. There was a single acute grade 3 GI toxicity of diarrhea and a single late grade 4 GI toxicity of bleeding. With a median follow-up of 12 months, the EPIC-26 scale showed an increase in urinary irritation (p < 0.001) and no differences for urinary incontinence (p=0.12) and GI QOL (p=0.65) and a decrease in hormonal/sexual QOL (p < 0.001 and p < 0.001). Mean ± SD PSA, maximum SUV on PET and maximum MRI PiRADS scores at baseline to 6 months were 15.4 ± 10.3 to 0.18 ± 0.40 ng/mL, 25.5 ± 19.5 to 4.5 ± 7.7, and 4.7 ± 0.6 to 2.9 ± 1.5 respectively.</p><p><strong>Conclusions: </strong>XXXXX demonstrated acceptable toxicity using 5 fraction SABR with PET/MRI directed SIB to prostate and lymph nodes.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4000,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"PSMA MRI Guided Prostate SABR ARGOS-CLIMBER Phase I/II Trial: A Primary Endpoint Analysis.\",\"authors\":\"Sherif Ramadan, Andrew Loblaw, Aneesh Dhar, Hatim Fakir, Lucas C Mendez, Andrew Warner, Matt Wronski, John Conyngham, Zahra Kassam, Vibhuti Kalia, Vivian S Tan, Priscila Crivellaro, Aaron D Ward, Jonathan Thiessen, Ting-Yim Lee, David Laidley, Glenn S Bauman\",\"doi\":\"10.1016/j.ijrobp.2025.04.039\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>The XXXXX trial is a multi-institutional phase I/II study utilizing a combined PSMA PET/MRI approach to treat dominant intraprostatic lesions (DILs) and affected lymph nodes in unfavorable intermediate and high-risk prostate cancer using a five fraction SABR and simultaneous in-field boost (SIB) technique. Here we report on the primary endpoint of toxicity within 6 months of treatment.</p><p><strong>Methods and materials: </strong>SIB volumes were defined utilizing a PET/MRI acquired using 18F-PSMA 1007. Five fraction SABR was planned to deliver doses (maximum SIB) to prostate 35 Gy (50 Gy), SV 25 Gy (50 Gy) and lymph nodes 25 Gy (35 Gy) while respecting OAR's. Toxicity and QOL were assessed according to CTCAE 5.0 and EPIC-26 during radiation, at 6 weeks post-treatment and at 6 months post treatment.</p><p><strong>Results: </strong>In total 50 patients were treated, 23 patients had unfavorable intermediate risk disease, 23 were high risk, and 4 were very high-risk prostate cancer. Median prostate SIB of 41.6 Gy (IQR: 39.3-44.8 Gy) was delivered to a median of 1 intra-prostatic lesion. Eighteen patients received nodal treatment. There was a single acute grade 3 GI toxicity of diarrhea and a single late grade 4 GI toxicity of bleeding. With a median follow-up of 12 months, the EPIC-26 scale showed an increase in urinary irritation (p < 0.001) and no differences for urinary incontinence (p=0.12) and GI QOL (p=0.65) and a decrease in hormonal/sexual QOL (p < 0.001 and p < 0.001). Mean ± SD PSA, maximum SUV on PET and maximum MRI PiRADS scores at baseline to 6 months were 15.4 ± 10.3 to 0.18 ± 0.40 ng/mL, 25.5 ± 19.5 to 4.5 ± 7.7, and 4.7 ± 0.6 to 2.9 ± 1.5 respectively.</p><p><strong>Conclusions: </strong>XXXXX demonstrated acceptable toxicity using 5 fraction SABR with PET/MRI directed SIB to prostate and lymph nodes.</p>\",\"PeriodicalId\":14215,\"journal\":{\"name\":\"International Journal of Radiation Oncology Biology Physics\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.4000,\"publicationDate\":\"2025-05-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Radiation Oncology Biology Physics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.ijrobp.2025.04.039\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Radiation Oncology Biology Physics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ijrobp.2025.04.039","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Purpose: The XXXXX trial is a multi-institutional phase I/II study utilizing a combined PSMA PET/MRI approach to treat dominant intraprostatic lesions (DILs) and affected lymph nodes in unfavorable intermediate and high-risk prostate cancer using a five fraction SABR and simultaneous in-field boost (SIB) technique. Here we report on the primary endpoint of toxicity within 6 months of treatment.
Methods and materials: SIB volumes were defined utilizing a PET/MRI acquired using 18F-PSMA 1007. Five fraction SABR was planned to deliver doses (maximum SIB) to prostate 35 Gy (50 Gy), SV 25 Gy (50 Gy) and lymph nodes 25 Gy (35 Gy) while respecting OAR's. Toxicity and QOL were assessed according to CTCAE 5.0 and EPIC-26 during radiation, at 6 weeks post-treatment and at 6 months post treatment.
Results: In total 50 patients were treated, 23 patients had unfavorable intermediate risk disease, 23 were high risk, and 4 were very high-risk prostate cancer. Median prostate SIB of 41.6 Gy (IQR: 39.3-44.8 Gy) was delivered to a median of 1 intra-prostatic lesion. Eighteen patients received nodal treatment. There was a single acute grade 3 GI toxicity of diarrhea and a single late grade 4 GI toxicity of bleeding. With a median follow-up of 12 months, the EPIC-26 scale showed an increase in urinary irritation (p < 0.001) and no differences for urinary incontinence (p=0.12) and GI QOL (p=0.65) and a decrease in hormonal/sexual QOL (p < 0.001 and p < 0.001). Mean ± SD PSA, maximum SUV on PET and maximum MRI PiRADS scores at baseline to 6 months were 15.4 ± 10.3 to 0.18 ± 0.40 ng/mL, 25.5 ± 19.5 to 4.5 ± 7.7, and 4.7 ± 0.6 to 2.9 ± 1.5 respectively.
Conclusions: XXXXX demonstrated acceptable toxicity using 5 fraction SABR with PET/MRI directed SIB to prostate and lymph nodes.
期刊介绍：
International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field.
This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
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