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

2026-03-04T01:53:03Z

Title: A randomized, active-controlled, multicenter, phase 3 clinical trial to evaluate the efficacy and safety of GV1001 in patients with benign prostatic hyperplasia Author(s): 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; Jae Shin Park; Yoon Soo Hah; Tae Gyun Kwon; Jae Wook Chung; Jae Il Chung; Dong Soo Ryu; Sung Woo Park; Kyung Seop Lee 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.

Stereotactic Ablative Radiotherapy for Delayed Retrobulbar Metastasis of Renal Cell Carcinoma: Therapeutic Outcomes and Practical Insights

2026-03-04T01:52:57Z

Title: Stereotactic Ablative Radiotherapy for Delayed Retrobulbar Metastasis of Renal Cell Carcinoma: Therapeutic Outcomes and Practical Insights Author(s): Sang Jun Byun; Byung Hoon Kim; Seung Gyu Park; Euncheol Choi Abstract: We present a rare case of delayed retrobulbar and adrenal metastases from renal cell carcinoma (RCC), diagnosed 5.5 years after radical nephrectomy. The patient exhibited symptomatic orbital involvement, with imaging revealing a hypervascular retrobulbar mass and an incidental right adrenal lesion, indicative of an oligometastatic state. Owing to the patient’s refusal of surgical resection, stereotactic ablative radiotherapy (SABR) was delivered to the retrobulbar lesion at a total dose of 40 Gy in five fractions, concurrently with immune checkpoint inhibitor therapy. Treatment planning prioritized sparing adjacent critical structures, including the optic chiasm and brainstem. Follow-up over 4 years demonstrated sustained radiologic stability and volume reduction in both metastatic lesions without evidence of progression. This case underscores the potential efficacy of SABR in achieving durable local control of RCC metastases, particularly in anatomically constrained regions where surgery is unfeasible. Moreover, it highlights the value of a multidisciplinary, multimodal treatment approach incorporating advanced radiotherapy techniques and systemic immunotherapy. Lastly, it reinforces the importance of prolonged surveillance in RCC survivors due to the potential for late metastatic recurrence at uncommon sites.

Sustained PSA screening is associated with downstaging and improved survival in prostate cancer: a 12-year Korean cohort study

2026-03-04T01:52:37Z

Title: Sustained PSA screening is associated with downstaging and improved survival in prostate cancer: a 12-year Korean cohort study Author(s): Jung Kwon Kim; Min Uk Park; Donghyun Lee; Hwa Jung Kim; Teakjun Shin; Myungsun Shim; Wan Suk Kim; Dalsan You; In Gab Jeong; Cheryn Song; Jun Hyuk Hong; Choung-Soo Kim; Hanjong Ahn Abstract: Objectives: To evaluate the impact of prostate-specific antigen (PSA) screening on prostate cancer (PCa) characteristics and survival outcomes in a contemporary cohort, amidst evolving PSA screening practices. Methods: We retrospectively analyzed clinicopathologic data of 5,437 men diagnosed with PCa via prostate biopsy at our institution between 2006 and 2018. Patients were categorized as PSA-detected (PCa detected by PSA testing in asymptomatic individuals) or Symptom-detected (PCa detected after PSA testing prompted by symptoms). Temporal trends in PSA screening and cancer characteristics were assessed using correlation and time-series analyses. Multivariable Cox regression evaluated the effect of PSA screening on overall and cancer-specific survival. Results: The PSA screening rate in our cohort increased from 46.4% in 2006 to 63.1% in 2018 (p < 0.001). Greater PSA screening uptake was associated with an increasing proportion of Gleason score 7 tumors (r = 0.608, p = 0.028), more localized-stage disease (r = 0.757, p = 0.003), and fewer cases of distant metastasis at diagnosis (r = -0.605, p = 0.028). The detection of clinically insignificant (low-risk) cancer rose modestly over time (r = 0.437, p = 0.136) but was not significantly influenced by PSA screening rates (r = 0.496, p = 0.085). On multivariate analysis, PSA screening was an independent predictor of improved overall survival (hazard ratio [HR] 0.54, p < 0.001) and cancer-specific survival (HR 0.46, p < 0.001). Conclusions: Increasing utilization of PSA screening correlated with a stage migration toward localized disease and a reduction in metastatic presentations, without a substantial increase in the detection of clinically insignificant cancer, as defined by Epstein criteria. PSA screening was an independent prognostic factor for better survival outcomes.

Effect of Povidone-Iodine Rectal Cleansing on Infectious Complications after Transrectal Ultrasound-Guided Prostate Biopsy

2026-01-14T00:40:38Z

Title: Effect of Povidone-Iodine Rectal Cleansing on Infectious Complications after Transrectal Ultrasound-Guided Prostate Biopsy Author(s): Tae Jin Jung; Hye Jin Byun; Teak Jun Shin; Hyunchan Jang; Wonho Jung; Byung Hoon Kim; Ji Yong Ha Abstract: To evaluate whether povidone-iodine rectal cleansing reduces infectious complications after transrectal ultrasound-guided prostate biopsy (TRUS-Bx). This retrospective study analyzed 2,118 patients who underwent TRUS-Bx between 2018 and 2023. The patients were divided into two groups: Group I (n = 682) received cephalosporins without rectal cleansing, whereas Group II (n = 1,436) received cephalosporins plus povidone-iodine rectal cleansing. The incidence of infectious complications such as fever, acute prostatitis, bacteremia, and sepsis was compared. Group II showed significantly lower rates of fever (0.2% vs. 0.9%), acute prostatitis (0.3% vs. 1.2%), and bacteremia (0.1% vs. 0.6%) than Group I (p < 0.05). However, no significant difference was observed in the incidence of sepsis between the two groups. No immediate or delayed adverse events associated with povidone-iodine rectal cleansing were observed during follow-up. Povidone-iodine rectal cleansing is a safe and effective adjunct to antibiotic prophylaxis for reducing post-TRUS-Bx infectious complications.