Gouveia Andre, Mesci Aruz, Isfahanian Naghmeh, Dayes Ian, Quan Kimmen, Goldberg Mira, Schnarr Kara Lynne, Lukka Himu, Cuthbert David, Hallock Abhiram, Douvi Georgia, Wright Jim, Swaminath Anand, Chow Tom, Diamond Kevin, Hajdok George, Maharaj Lindsay, Ewusie Joycelyne, Tsakiridis Theodoros
Radiation Oncology, Juravinski Cancer Centre, Hamilton Health Science, Hamilton, Ontario, Canada.
Department of Oncology, McMaster University, Hamilton, Ontario, Canada.
Prostate. 2025 Jul;85(10):977-985. doi: 10.1002/pros.24905. Epub 2025 Apr 27.
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.
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.
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.
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.
ClinicalTrials.gov identifier: NCT03380806.
对于预后不良的中高危前列腺癌，标准治疗方法包括雄激素剥夺疗法（ADT）联合盆腔常规分割（CF）外照射放疗（EBRT），以及对前列腺进行CF-EBRT或近距离放疗强化。本试验比较了盆腔CF-EBRT后CF-EBRT强化与立体定向体部放疗（SBRT）强化的效果。
患者被随机分为两组，一组在盆腔CF-EBRT（23 - 25次分割，45 - 46 Gy）后接受CF-EBRT强化（15 - 17次分割，32 - 34 Gy），另一组接受SBRT强化（每周一次，共三次分割，19.5 - 21 Gy）。主要目标是使用扩展前列腺指数综合评分（EPIC）评估放疗后3个月时的早期胃肠道（GI）和泌尿生殖系统（GU）生活质量（QoL）。次要目标包括长期QoL、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。
100例随机分组的患者中，53例接受CF-EBRT，47例接受SBRT。平均随访18.5个月后，治疗后3个月时，CF-EBRT组和SBRT组在尿（11.5对8.6，p = 0.23）、肠道（5.2对6.4，p = 0.57）及总体QoL（8.3对7.5，p = 0.61）的EPIC评分变化方面未观察到显著差异。IPSS评分相似（p = 0.11），美国国立癌症研究所常见不良反应事件评价标准第5版（CTCAE v.5.0）毒性发生率相当，比值比为0.90（p > 0.99）。两组生化失败率均低于5%。
这是第一项报告预后不良的中高危前列腺癌患者接受SBRT强化放疗后QoL结果的随机试验。盆腔CF-EBRT后进行SBRT强化耐受性良好，在QoL和毒性方面与CF-EBRT强化效果相当。需要进一步随访以评估对QoL、毒性和疾病控制的长期影响。
ClinicalTrials.gov标识符：NCT03380806。
