一项高剂量率（HDR）和低剂量率（LDR）近距离放疗作为局部前列腺癌单药治疗的随机II期试验：加拿大癌症试验组PR19 （NCT02960087）的初始组分析。

IF 5.3 1区医学 Q1 ONCOLOGY

Radiotherapy and Oncology Pub Date : 2025-09-08 DOI:10.1016/j.radonc.2025.111124

G. Morton , E. Vigneault , M. Barkati , J. Helou , T.M. Niazi , J. Robinson , D.A. Loblaw , C.L. Tseng , H.T. Chung , G. Delouya , C. Menard , A.G. Martin , P. Chung , D. Batchelar , M.D. Brundage , K. Whelan , K. Ding , W. Parulekar

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引用次数: 0

摘要

目的/目的：低剂量率近距离放射治疗（LDR）和高剂量率近距离放射治疗（HDR）是治疗有利风险前列腺癌的两种选择。我们假设HDR提供了相当的疾病控制和更少的尿毒性。主要目的是确定48 个月时前列腺癌的控制情况，定义为PSA < 0.4 ng/ml。材料/方法：符合条件的患者为低危和中危疾病。随机分组为I-125至144 Gy的1组LDR，或19 Gy x1 + 前列腺内增高的2组HDR。随访包括PSA、毒性（CTCAE v 4.0）和生活质量（EPIC 26）。由于结果不佳的证据，第2组于2019年5月关闭，第三组（HDR 13.5 Gy x 2）开放。我们报告了研究修改前第1组（LDR）和第2组（HDR单组分）的结局。结果：103例患者随机分为：51例LDR组（第1组）和52例HDR组（第2组）。中位年龄65岁 岁；76 % Gleason 3 + 4,90 % PSA 结论：LDR近距离放疗在4 年时前列腺癌疾病控制率较高，但在前6 个月对泌尿系统症状的影响较差。单组分HDR与不可接受的癌症控制有关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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A randomized Phase II trial of High Dose-Rate (HDR) and Low Dose-Rate (LDR) brachytherapy as monotherapy in localized prostate cancer: analysis of initial arms of Canadian cancer trials group PR19 (NCT02960087)

Purpose/objectives

Low Dose-Rate Brachytherapy (LDR) and High Dose-Rate Brachytherapy (HDR) are options for favorable risk prostate cancer. We hypothesized that HDR provides comparable disease control with less urinary toxicity. Primary objective was to determine prostate cancer control at 48 months, defined as a PSA < 0.4 ng/ml.

Materials/methods

Eligible patients had low and intermediate risk diseases. Randomization was to Arm 1 LDR with I-125 to 144 Gy, or Arm 2 HDR with 19 Gy x1 + intraprostatic boost. Follow-up included PSA, toxicity (CTCAE v 4.0), and Quality of Life (EPIC 26). Arm 2 was closed in May 2019 due to evidence of inferior outcomes, and a third arm (HDR 13.5 Gy x 2) was opened. We report outcomes of Arms 1 (LDR) and 2 (HDR single fraction) prior to study amendment.

Results

103 patients were randomized: 51 to LDR (Arm 1) and 52 to HDR (Arm 2). Median age 65 years; 76 % had Gleason 3 + 4, 90 % PSA < 10, and 80 % stage T1c. Median follow-up 53 months. PSA control at 4 years was 78.4 % for LDR, and 21.2 % for HDR. Local progression rates: 2 % LDR, 13.5 % HDR. Grade 3 toxicity occurred in 6 patients for LDR and 2 patients Arm 2. Urinary irritative and bowel symptoms were worse in the first 6 months for LDR.

Conclusions

LDR brachytherapy has high prostate cancer disease control rate at 4 years, although with worse impact on urinary symptoms in the first 6 months. Single fraction HDR was associated with unacceptable cancer control.

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来源期刊

Radiotherapy and Oncology 医学-核医学

CiteScore

10.30

自引率

10.50%

发文量

2445

审稿时长

45 days

期刊介绍： Radiotherapy and Oncology publishes papers describing original research as well as review articles. It covers areas of interest relating to radiation oncology. This includes: clinical radiotherapy, combined modality treatment, translational studies, epidemiological outcomes, imaging, dosimetry, and radiation therapy planning, experimental work in radiobiology, chemobiology, hyperthermia and tumour biology, as well as data science in radiation oncology and physics aspects relevant to oncology.Papers on more general aspects of interest to the radiation oncologist including chemotherapy, surgery and immunology are also published.