Purpose

This study was undertaken to determine the safety and efficacy of fexapotide triflutate (FT) 2.5 mg and 15 mg for the treatment of Grade Group 1 prostate cancer.

Methods

Prospective randomized transrectal intraprostatic single injection FT 2.5 mg (n = 49), FT 15 mg (n = 48) and control active surveillance (AS) (n = 49) groups were compared in 146 patients at 28 U.S. sites, with elective AS crossover (n = 18) to FT after first follow-up biopsy at 45 days. Patients were followed for 5 years including biopsies (baseline, 45 days, and 18, 36, and 54 months thereafter), and urological evaluations with PSA every 6 months. Patients with Gleason grade increase or who elected surgical or radiotherapeutic intervention exited the study and were cumulatively included in the data analysis. Percentage of normal biopsies in baseline focus quadrant, tumor grades, and volumes; and outcomes including Gleason grade in entire prostate as well as treated prostate lobe, interventions associated with Gleason grade increase and total incidence of interventions were assessed.

Results

Significantly improved long-term clinical outcomes were found after 4-year follow-up, with percentages of patients progressing to interventions with and without Gleason grade increase significantly reduced by FT single treatment. Results in the FT 15-mg group were superior to the FT 2.5-mg dose group. There were no drug-related serious adverse events (SAEs).

Conclusions

FT showed statistically significant long-term efficacy in the treatment of Grade Group 1 patients regarding clinical and pathological progression. FT 15 mg showed superior results to FT 2.5 mg. There were no drug-related SAEs; FT injection was well tolerated.

中文翻译：

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甲氟哌草胺三氟甲酸酯注射液治疗1级前列腺癌的前瞻性评估：4年结果。

目的

进行这项研究是为了确定2.5毫克和15毫克非氟哌肽三氟甲酸酯（FT）用于治疗第1级前列腺癌的安全性和有效性。

方法

 在美国28个地点的146例患者中比较了前瞻性随机经直肠前列腺内单次注射FT 2.5 mg（n  = 49），FT 15 mg（n  = 48）和对照组主动监测（AS）（n = 49）组，并进行了选择性AS交叉（n = 18）于45天首次随访活检后转为FT。对患者进行了5年的随访，包括活检（基线，45天以及之后的18、36和54个月），并每6个月进行PSA泌尿系统评估。格里森分级增高或选择手术或放射治疗干预的患者退出研究，并逐渐纳入数据分析。正常活检在基线聚焦象限，肿瘤等级和体积中所占的百分比；评估了包括整个前列腺以及治疗过的前列腺叶的格里森分级在内的结局，与格里森分级增加相关的干预措施以及干预的总发生率。

结果

随访4年后，发现长期临床疗效显着改善，接受FT单药治疗可显着降低有或没有Gleason分级增加的进展为干预措施的患者百分比。FT 15 mg组的结果优于FT 2.5 mg剂量组。没有与药物相关的严重不良事件（SAE）。

结论

就临床和病理进展而言，FT在治疗1级组患者方面显示出统计学上显着的长期疗效。FT 15 mg的结果优于FT 2.5 mg。没有与药物有关的SAE；FT注射耐受性良好。