Juanita Crook, Jui-Chi Cheng, Gregory Arbour, Cynthia Araujo, Deidre Batchelar, David Kim, David Petrik, Tracey Rose, Francois Bachand
{"title":"高剂量率和低剂量率前列腺近距离放疗联合外束放疗治疗不良前列腺癌的随机比较：中位随访74个月后的疗效结果。","authors":"Juanita Crook, Jui-Chi Cheng, Gregory Arbour, Cynthia Araujo, Deidre Batchelar, David Kim, David Petrik, Tracey Rose, Francois Bachand","doi":"10.1016/j.ijrobp.2025.03.053","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>This single-center randomized trial compared health-related Quality of Life for men with unfavorable localized prostate cancer treated with combined pelvic external beam radiation therapy (EBRT) and prostate brachytherapy, randomly assigned to high-dose rate (HDR) or low-dose rate (LDR). We now report efficacy outcomes with a minimum 5-year follow-up.</p><p><strong>Materials and methods: </strong>Consenting patients receiving pelvic EBRT combined with prostate brachytherapy were randomized to either LDR (110 Gy) or HDR (15 Gy). Androgen deprivation was used in 76% of patients. EBRT delivered 46 Gy/23 using intensity modulated radiation therapy or volumetric-modulated arc therapy (68%) or 3-dimensional conformal radiotherapy (32%). Follow-up up was 1, 3, and 6 months, then every 6 months to 3 years, and then annually. Prostate-specific antigen (PSA) ≤0.2 ng/mL at 4 years defined cure. Biochemical failure-free survival (bFFS) and overall survival were calculated by Kaplan-Meier methods. All failures were investigated by imaging (computed tomography, bone scan, and/or Prostate Specific Membrane Antigen- Positron Emission Tomography (PET) ± biopsy if PET was not available.</p><p><strong>Results: </strong>From January 2014 to December 2019, 195 men (42% intermediate risk/58% high risk) were randomly assigned: 108 to HDR and 87 to LDR. The median age was 71 years. Median PSA was 11.6 ng/mL (mean, 27.0 ng/mL). Median follow-up was 74 months (43-116 m). The median PSA nadirs were 0.07 and 0.08 in HDR and LDR (P = .16), and time to nadir was 13.8 and 14.1 months, respectively (P = .87). Four-year PSA ≤0.2 was maintained in 81% and 83% of HDR and LDR (P = .91). Eight-year bPFS (nadir + 2) was 86% and 85%, respectively. Eighteen of 22 biochemical failures have been identified; 3 are isolated local failures, whereas 14 are distant failures (isolated 11; 3 combined).</p><p><strong>Conclusions: </strong>In this small, randomized comparison, efficacy analysis shows no difference between LDR and HDR boost in bPFS at 5 and 8 years and confirms the excellent efficacy of dose escalation using prostate brachytherapy as documented in Ascende-RT for unfavorable localized prostate cancer.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4000,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Randomized Comparison of High-Dose-Rate and Low-Dose-Rate Prostate Brachytherapy Combined With External Beam Radiation Therapy for Unfavorable Prostate Cancer: Efficacy Results After Median Follow-up of 74 Months.\",\"authors\":\"Juanita Crook, Jui-Chi Cheng, Gregory Arbour, Cynthia Araujo, Deidre Batchelar, David Kim, David Petrik, Tracey Rose, Francois Bachand\",\"doi\":\"10.1016/j.ijrobp.2025.03.053\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>This single-center randomized trial compared health-related Quality of Life for men with unfavorable localized prostate cancer treated with combined pelvic external beam radiation therapy (EBRT) and prostate brachytherapy, randomly assigned to high-dose rate (HDR) or low-dose rate (LDR). We now report efficacy outcomes with a minimum 5-year follow-up.</p><p><strong>Materials and methods: </strong>Consenting patients receiving pelvic EBRT combined with prostate brachytherapy were randomized to either LDR (110 Gy) or HDR (15 Gy). Androgen deprivation was used in 76% of patients. EBRT delivered 46 Gy/23 using intensity modulated radiation therapy or volumetric-modulated arc therapy (68%) or 3-dimensional conformal radiotherapy (32%). Follow-up up was 1, 3, and 6 months, then every 6 months to 3 years, and then annually. Prostate-specific antigen (PSA) ≤0.2 ng/mL at 4 years defined cure. Biochemical failure-free survival (bFFS) and overall survival were calculated by Kaplan-Meier methods. All failures were investigated by imaging (computed tomography, bone scan, and/or Prostate Specific Membrane Antigen- Positron Emission Tomography (PET) ± biopsy if PET was not available.</p><p><strong>Results: </strong>From January 2014 to December 2019, 195 men (42% intermediate risk/58% high risk) were randomly assigned: 108 to HDR and 87 to LDR. The median age was 71 years. Median PSA was 11.6 ng/mL (mean, 27.0 ng/mL). Median follow-up was 74 months (43-116 m). The median PSA nadirs were 0.07 and 0.08 in HDR and LDR (P = .16), and time to nadir was 13.8 and 14.1 months, respectively (P = .87). Four-year PSA ≤0.2 was maintained in 81% and 83% of HDR and LDR (P = .91). Eight-year bPFS (nadir + 2) was 86% and 85%, respectively. Eighteen of 22 biochemical failures have been identified; 3 are isolated local failures, whereas 14 are distant failures (isolated 11; 3 combined).</p><p><strong>Conclusions: </strong>In this small, randomized comparison, efficacy analysis shows no difference between LDR and HDR boost in bPFS at 5 and 8 years and confirms the excellent efficacy of dose escalation using prostate brachytherapy as documented in Ascende-RT for unfavorable localized prostate cancer.</p>\",\"PeriodicalId\":14215,\"journal\":{\"name\":\"International Journal of Radiation Oncology Biology Physics\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.4000,\"publicationDate\":\"2025-04-03\",\"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.2025.03.053\",\"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.2025.03.053","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
A Randomized Comparison of High-Dose-Rate and Low-Dose-Rate Prostate Brachytherapy Combined With External Beam Radiation Therapy for Unfavorable Prostate Cancer: Efficacy Results After Median Follow-up of 74 Months.
Purpose: This single-center randomized trial compared health-related Quality of Life for men with unfavorable localized prostate cancer treated with combined pelvic external beam radiation therapy (EBRT) and prostate brachytherapy, randomly assigned to high-dose rate (HDR) or low-dose rate (LDR). We now report efficacy outcomes with a minimum 5-year follow-up.
Materials and methods: Consenting patients receiving pelvic EBRT combined with prostate brachytherapy were randomized to either LDR (110 Gy) or HDR (15 Gy). Androgen deprivation was used in 76% of patients. EBRT delivered 46 Gy/23 using intensity modulated radiation therapy or volumetric-modulated arc therapy (68%) or 3-dimensional conformal radiotherapy (32%). Follow-up up was 1, 3, and 6 months, then every 6 months to 3 years, and then annually. Prostate-specific antigen (PSA) ≤0.2 ng/mL at 4 years defined cure. Biochemical failure-free survival (bFFS) and overall survival were calculated by Kaplan-Meier methods. All failures were investigated by imaging (computed tomography, bone scan, and/or Prostate Specific Membrane Antigen- Positron Emission Tomography (PET) ± biopsy if PET was not available.
Results: From January 2014 to December 2019, 195 men (42% intermediate risk/58% high risk) were randomly assigned: 108 to HDR and 87 to LDR. The median age was 71 years. Median PSA was 11.6 ng/mL (mean, 27.0 ng/mL). Median follow-up was 74 months (43-116 m). The median PSA nadirs were 0.07 and 0.08 in HDR and LDR (P = .16), and time to nadir was 13.8 and 14.1 months, respectively (P = .87). Four-year PSA ≤0.2 was maintained in 81% and 83% of HDR and LDR (P = .91). Eight-year bPFS (nadir + 2) was 86% and 85%, respectively. Eighteen of 22 biochemical failures have been identified; 3 are isolated local failures, whereas 14 are distant failures (isolated 11; 3 combined).
Conclusions: In this small, randomized comparison, efficacy analysis shows no difference between LDR and HDR boost in bPFS at 5 and 8 years and confirms the excellent efficacy of dose escalation using prostate brachytherapy as documented in Ascende-RT for unfavorable localized prostate cancer.
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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