Background

Salvage radiotherapy (SRT) is utilized for biochemical progression of prostate cancer after radical prostatectomy (RP).

Objective

To report the outcomes of the SAKK 09/10 trial comparing conventional and dose-intensified SRT.

Design, setting, and participants

SAKK 09/10 was a randomized, multicenter, phase 3 trial that recruited men with biochemical progression after RP.

Intervention

Patients were randomly assigned to conventional-dose (64 Gy) or dose-intensified SRT (70 Gy) to the prostate bed without hormonal therapy.

Outcome measurements and statistical analysis

The primary endpoint was freedom from biochemical progression (FFBP). Secondary endpoints included clinical progression-free survival (PFS), time to hormonal treatment, overall survival (OS), acute and late toxicity (Common Terminology Criteria for Adverse Events v4.0), and quality of life (QoL).

Results and limitations

Between February 2011 and April 2014, 350 patients were randomly assigned to 64 Gy (n = 175) or 70 Gy (n = 175). Median prostate-specific antigen at randomization was 0.3 ng/ml. After median follow-up of 6.2 yr, the median FFBP was 8.2 yr in the 64 Gy arm and 7.6 in the 70 Gy arm (log-rank p = 0.4), with a hazard ratio of 1.14 (95% confidence interval 0.82–1.60). The 6-year FFBP rates were 62% and 61%, respectively. No significant differences in clinical PFS, time to hormonal treatment, or OS were observed. Late grade 2 and 3 genitourinary toxicity was observed in 35 (21%) and 13 (7.9%) patients in the 64 Gy arm, and 46 (26%) and seven (4%) in the 70 Gy arm, respectively (p = 0.8). Late grade 2 and 3 gastrointestinal toxicity was observed in 12 (7.3%) and seven patients (4.2%) in the 64 Gy arm, and 35 (20%) and four (2.3%) in the 70 Gy arm, respectively (p = 0.009). There were no significant differences in QoL.

Conclusions

Conventional-dose SRT to the prostate bed is sufficient in patients with early biochemical progression of prostate cancer after RP.

Patient summary

The optimal radiation therapy dose for patients who have increased tumor markers after surgery for prostate cancer is unclear. We found that administering a higher dose only increased the gastrointestinal side effects without providing any benefits to the patient.

This clinical trial is registered on ClinicalTrials.gov as NCT01272050.

中文翻译：

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前列腺切除术后生化复发性前列腺癌的剂量强化与常规剂量挽救性放疗：SAKK 09/10 随机 3 期试验

背景

挽救性放疗 (SRT) 用于根治性前列腺切除术 (RP) 后前列腺癌的生化进展。

客观的

报告比较常规和剂量强化 SRT 的 SAKK 09/10 试验的结果。

设计、设置和参与者

SAKK 09/10 是一项随机、多中心、3 期试验，招募了 RP 后生化进展的男性。

干涉

患者被随机分配到没有激素治疗的前列腺床常规剂量（64 Gy）或剂量强化 SRT（70 Gy）组。

结果测量和统计分析

主要终点是无生化进展（FFBP）。次要终点包括临床无进展生存期（PFS）、激素治疗时间、总生存期（OS）、急性和晚期毒性（不良事件通用术语标准v4.0）和生活质量（QoL）。

结果和局限性

2011 年 2 月至 2014 年 4 月期间，350 名患者被随机分配到 64 Gy ( n  = 175) 或 70 Gy ( n  = 175)。随机化时的中位前列腺特异性抗原为 0.3 ng/ml。中位随访 6.2 年后，64 Gy 组的中位 FFBP 为 8.2 年，70 Gy 组为 7.6 年（对数秩p  = 0.4），风险比为 1.14（95% 置信区间 0.82-1.60 ）。6 年 FFBP 率分别为 62% 和 61%。在临床 PFS、激素治疗时间或 OS 方面未观察到显着差异。64 Gy 组的 35 名（21%）和 13 名（7.9%）患者以及 70 Gy 组的 46 名（26%）和 7 名（4%）患者分别观察到 2 级和 3 级晚期泌尿生殖系统毒性（p = 0.8)。64 Gy 组有 12 名（7.3%）和 7 名（4.2%）患者观察到 2 级和 3 级晚期胃肠道毒性，70 Gy 组有 35 名（20%）和 4 名（2.3%）患者（p  = 0.009)。生活质量没有显着差异。

结论

对于 RP 后前列腺癌早期生化进展的患者，常规剂量的前列腺床 SRT 就足够了。

患者总结

对于前列腺癌手术后肿瘤标志物增加的患者，最佳放射治疗剂量尚不清楚。我们发现给予更高剂量只会增加胃肠道副作用，而不会给患者带来任何好处。

该临床试验在 ClinicalTrials.gov 上注册为 NCT01272050。