Primary Analysis of (NCT03380806) a Phase II Randomized Trial of Stereotactic Body Radiotherapy Boost Versus Conventional Fractionation External Beam Radiotherapy Boost in Unfavorable-Intermediate and High-Risk Prostate Cancer.

IF 2.6 3区医学 Q3 ENDOCRINOLOGY & METABOLISM

Prostate Pub Date : 2025-07-01 Epub Date: 2025-04-27 DOI:10.1002/pros.24905

Andre Gouveia, Aruz Mesci, Naghmeh Isfahanian, Ian Dayes, Kimmen Quan, Mira Goldberg, Kara Lynne Schnarr, Himu Lukka, David Cuthbert, Abhiram Hallock, Georgia Douvi, Jim Wright, Anand Swaminath, Tom Chow, Kevin Diamond, George Hajdok, Lindsay Maharaj, Joycelyne Ewusie, Theodoros Tsakiridis

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引用次数: 0

Abstract

Background: Standard treatment for unfavorable-intermediate and high-risk prostate cancer involves androgen deprivation therapy (ADT) in combination with pelvic conventional fractionation (CF) external beam radiotherapy (EBRT) and a CF-EBRT or brachytherapy boost to the prostate. This trial compared CF-EBRT boost with stereotactic body radiotherapy (SBRT) boost after pelvic CF-EBRT.

Methods: Patients were randomized to receive a boost using either CF-EBRT (32-34 Gy in 15-17 fractions) or SBRT (19.5-21 Gy in three weekly fractions) following pelvic CF-EBRT (45-46 Gy in 23-25 fractions). The primary objective was to assess early (3-month post-radiotherapy) gastrointestinal (GI) and genitourinary (GU) quality of life (QoL), using the expanded prostate index composite (EPIC) score. Secondary objectives included long-term QoL, International Prostate Symptom Score (IPSS) changes, toxicity assessments, and long-term disease control outcomes. Linear regression and Fisher's exact test were used for analysis.

Results: Of the 100 patients randomized, 53 received CF-EBRT, and 47 received SBRT. After a mean follow-up of 18.5 months, no significant differences were observed in EPIC score changes between CF-EBRT and SBRT at 3 months posttreatment for urinary (11.5 vs. 8.6, p = 0.23), bowel (5.2 vs. 6.4, p = 0.57), and overall QoL (8.3 vs. 7.5, p = 0.61). IPSS scores were similar (p = 0.11), and CTCAE v.5.0 toxicity rates were comparable, with an odds ratio of 0.90 (p > 0.99). Biochemical failure rates were under 5% for both groups.

Conclusions: This is the first randomized trial to report QoL outcomes after SBRT boost radiotherapy in patients with unfavorable-intermediate and high-risk prostate cancer. SBRT boost after pelvic CF-EBRT is well-tolerated and demonstrates comparable outcomes in QoL and toxicity to the CF-EBRT boost. Further follow-up is needed to assess the long-term effects on QoL, toxicity, and disease control.

Trial registration: ClinicalTrials.gov identifier: NCT03380806.

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（NCT03380806）一项立体定向体放疗增强与传统分步外束放疗增强治疗不良中高危前列腺癌的II期随机试验的初步分析

背景：不良中高危前列腺癌的标准治疗包括雄激素剥夺治疗（ADT）联合盆腔常规分割（CF）外束放疗（EBRT）和CF-EBRT或近距离前列腺强化治疗。该试验比较了盆腔CF-EBRT增强与立体定向体放疗（SBRT）增强。方法：患者在盆腔CF-EBRT （45-46 Gy, 23-25 Gy）后随机接受CF-EBRT （32-34 Gy， 15-17次）或SBRT （19.5-21 Gy， 3周次）的增强治疗。主要目的是评估早期（放疗后3个月）胃肠道（GI）和泌尿生殖系统（GU）生活质量（QoL），使用扩展前列腺指数综合（EPIC）评分。次要目标包括长期生活质量、国际前列腺症状评分（IPSS）变化、毒性评估和长期疾病控制结果。采用线性回归和Fisher精确检验进行分析。结果：在随机分组的100例患者中，53例接受CF-EBRT， 47例接受SBRT。平均随访18.5个月后，治疗后3个月，CF-EBRT和SBRT在泌尿（11.5 vs. 8.6, p = 0.23）、肠道（5.2 vs. 6.4, p = 0.57）和总体生活质量（8.3 vs. 7.5, p = 0.61）方面的EPIC评分变化无显著差异。IPSS评分相似（p = 0.11）， CTCAE v.5.0毒性率具有可比性，比值比为0.90 （p = 0.99）。两组生化失败率均在5%以下。结论：这是第一项报告不良中高危前列腺癌患者接受SBRT强化放疗后生活质量结果的随机试验。盆腔CF-EBRT后增强SBRT耐受性良好，在生活质量和毒性方面与CF-EBRT增强结果相当。需要进一步随访以评估对生活质量、毒性和疾病控制的长期影响。试验注册：ClinicalTrials.gov标识符：NCT03380806。

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来源期刊

Prostate 医学-泌尿学与肾脏学

CiteScore

5.10

自引率

3.60%

发文量

180

审稿时长

1.5 months

期刊介绍： The Prostate is a peer-reviewed journal dedicated to original studies of this organ and the male accessory glands. It serves as an international medium for these studies, presenting comprehensive coverage of clinical, anatomic, embryologic, physiologic, endocrinologic, and biochemical studies.