Crook Juanita, Cheng Jui-Chi, Arbour Gregory, Araujo Cynthia, Batchelar Deidre, Kim David, Petrik David, Rose Tracey, Bachand Francois
Radiation Oncology, BCCancer Kelowna, Kelowna, British Columbia, Canada; University of British Columbia, Vancouver, British Columbia, Canada.
Radiation Oncology, BCCancer Kelowna, Kelowna, British Columbia, Canada.
Int J Radiat Oncol Biol Phys. 2025 Sep 1;123(1):195-203. doi: 10.1016/j.ijrobp.2025.03.053. Epub 2025 Apr 3.
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.
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.
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).
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.
本单中心随机试验比较了接受盆腔外照射放疗（EBRT）联合前列腺近距离放疗的局限性前列腺癌患者的健康相关生活质量，这些患者被随机分配至高剂量率（HDR）或低剂量率（LDR）治疗组。我们现在报告至少5年随访后的疗效结果。
同意接受盆腔EBRT联合前列腺近距离放疗的患者被随机分为LDR（110 Gy）组或HDR（15 Gy）组。76%的患者使用了雄激素剥夺治疗。EBRT采用调强放射治疗或容积调强弧形治疗（68%）或三维适形放疗（32%）给予46 Gy/23次。随访时间为1、3和6个月，然后每6个月至3年，之后每年随访一次。4年时前列腺特异性抗原（PSA）≤0.2 ng/mL定义为治愈。采用Kaplan-Meier方法计算无生化失败生存期（bFFS）和总生存期。所有失败情况均通过影像学检查（计算机断层扫描、骨扫描和/或前列腺特异性膜抗原正电子发射断层扫描（PET），如果没有PET则进行活检）进行调查。
2014年1月至2019年12月，195名男性（42%为中危/58%为高危）被随机分组：108名进入HDR组，87名进入LDR组。中位年龄为71岁。中位PSA为11.6 ng/mL（平均为27.0 ng/mL）。中位随访时间为74个月（43 - 116个月）。HDR组和LDR组的中位PSA最低点分别为0.07和0.08（P = 0.16），达到最低点的时间分别为13.8个月和14.1个月（P = 0.87）。4年时PSA≤0.2在HDR组和LDR组中分别维持在81%和83%（P = 0.91）。8年的bPFS（最低点 + 2）分别为86%和85%。22例生化失败中已确定18例；3例为孤立的局部失败，而14例为远处失败（孤立的11例；3例合并）。
在这项小型随机比较中，疗效分析显示LDR和HDR增敏在5年和8年的bPFS方面无差异，并证实了如Ascende-RT中所记录的，对于局限性前列腺癌，使用前列腺近距离放疗进行剂量递增具有出色的疗效。
