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

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.