A randomized, active-controlled, multicenter, phase 3 clinical trial to evaluate the efficacy and safety of GV1001 in patients with benign prostatic hyperplasia

IF 2.7 2区医学 Q2 UROLOGY & NEPHROLOGY

Prostate International Pub Date : 2025-06-01 DOI:10.1016/j.prnil.2024.10.001

Teak Jun Shin , Ji Yong Ha , Se Yun Kwon , Dong Jin Park , Jang Hwan Kim , Sung Won Lee , In Gab Jeong , Ji Youl Lee , Tag Keun Yoo , Tae Hyoung Kim , Du Geon Moon , Sung Kyu Hong , Jin Seon Cho , Hong Sang Moon , Jeong Woo Lee , Seok Joong Yun , Youn Soo Jeon , Jong Gwan Park , Taek Won Kang , Ki Hak Moon , Kyung Seop Lee

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Abstract

Objectives

To determine and compare the efficacy and safety of GV1001 and 5 mg finasteride for benign prostatic hyperplasia (BPH) patients.

Patients and methods

This randomized, active-controlled, multicenter, phase 3 clinical trial enrolled 423 patients aged ≥50 years with a prostate volume (PV) >30 mL. Patients were randomized into Group 1 (GV1001 0.56 mg + finasteride placebo), Group 2 (GV1001 1.12 mg + finasteride placebo), or Group 3 (GV1001 placebo +5 mg finasteride). The patients received the study drug during clinic visits every 2 weeks at weeks 0–22. Changes in the international prostate symptom score (IPSS), PV, maximum urinary flow rate (Qmax), prostate-specific antigen (PSA) level, residual urine volume, testosterone and dihydrotestosterone (DHT) levels, and international index of erectile function (IIEF) were assessed.

Results

We included 408 (96.45%) patients (Group 1, n = 138; Group 2, n = 134; Group 3, n = 136) in full analysis set for primary efficacy evaluations. All groups showed significant decreases and increases in the IPSS and Qmax, respectively (Groups 1, 2, and 3, IPSS: −4.78 ± 6.50, −4.99 ± 6.66, and −5.51 ± 6.42, respectively; P < 0.0001; Qmax: P = 0.0005, P = 0.0039, and P < 0.0001, respectively). PV reductions were observed in Groups 2 and 3 (−0.75 ± 8.21 mL [P = 0.3280] and −2.47 ± 7.92 mL [P = 0.0010], respectively). The PSA and testosterone levels of Group 3 significantly decreased and changed, respectively (−0.90 ± 1.25 ng/mL, P < 0.0001 and P < 0.0001, respectively). No significant differences were observed in the residual urine volume. DHT significantly decreased in all groups (Groups 1, 2, and 3: −71.41 ± 244.06 ng/mL [P = 0.0025], −73.84 ± 249.26 ng/mL [P = 0.0019], and −106.60 ± 178.29 ng/mL [P < 0.0001], respectively). Only Group 3 exhibited a significantly decreased IIEF (−3.06 ± 15.34; P = 0.0323). Acute urinary retention occurred in one patient in Group 2. No patients underwent prostate surgery or minimally invasive procedures during the study.

Conclusions

GV1001 exhibited corresponding efficacy and tolerability, providing evidence of amelioration in urinary symptoms among patients with BPH in comparison to the use of 5 mg finasteride.

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一项随机、主动对照、多中心、3期临床试验，旨在评估GV1001在良性前列腺增生患者中的疗效和安全性

目的比较GV1001和5mg非那雄胺治疗良性前列腺增生（BPH）的疗效和安全性。患者和方法这项随机、主动对照、多中心、3期临床试验招募了423例年龄≥50岁、前列腺体积（PV） >； 30ml的患者。患者被随机分为1组（GV1001 0.56 mg +非那雄胺安慰剂）、2组（GV1001 1.12 mg +非那雄胺安慰剂）或3组（GV1001安慰剂+ 5mg非那雄胺）。患者在0-22周每2周就诊时接受研究药物。评估国际前列腺症状评分（IPSS）、PV、最大尿流率（Qmax）、前列腺特异性抗原（PSA）水平、残尿量、睾酮和双氢睾酮（DHT）水平、国际勃起功能指数（IIEF）的变化。结果共纳入408例（96.45%）患者(第一组，n = 138；第二组，n = 134；第3组（n = 136）为主要疗效评价全分析组。各组IPSS和Qmax分别显著降低和升高(1、2、3组IPSS分别为- 4.78±6.50、- 4.99±6.66、- 5.51±6.42；P & lt;0.0001;Qmax: P = 0.0005, P = 0.0039, P <；分别为0.0001)。第2组和第3组PV降低（分别为- 0.75±8.21 mL [P = 0.3280]和- 2.47±7.92 mL [P = 0.0010]）。3组PSA和睾酮水平分别显著降低和改变(- 0.90±1.25 ng/mL, P <；0.0001和P <；分别为0.0001)。两组的剩余尿量无显著差异。各组DHT均显著降低(1、2、3组分别为- 71.41±244.06 ng/mL [P = 0.0025]、- 73.84±249.26 ng/mL [P = 0.0019]、- 106.60±178.29 ng/mL [P <；分别为0.0001])。只有3组IIEF显著降低(−3.06±15.34；P = 0.0323)。2组1例患者出现急性尿潴留。在研究期间，没有患者接受前列腺手术或微创手术。结论与使用5mg非那雄胺相比，sgv1001具有相应的疗效和耐受性，为BPH患者泌尿系统症状的改善提供了证据。

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来源期刊

Prostate International Medicine-Urology

CiteScore

4.40

自引率

26.70%

发文量

审稿时长

35 days

期刊介绍： Prostate International (Prostate Int, PI), the official English-language journal of Asian Pacific Prostate Society (APPS), is an international peer-reviewed academic journal dedicated to basic and clinical studies on prostate cancer, benign prostatic hyperplasia, prostatitis, and ...