Objective
To test the non‐inferiority of bipolar transurethral vaporization of the prostate (TUVP) compared to GreenLight laser (GL) photoselective vaporization of the prostate (PVP) for reduction of benign prostatic hyperplasia‐related lower urinary tract symptoms in a randomized trial.
Methods
Eligible patients with prostate volumes of 30–80 mL were randomly allocated to GL‐PVP (n = 58) or bipolar TUVP (n = 61). Non‐inferiority of symptom score (International Prostate Symptom Score [IPSS]) at 24 months was evaluated. All peri‐operative variables were recorded and compared. Urinary (IPSS, maximum urinary flow rate and post‐void residual urine volume) and sexual (International Index of Erectile Function‐15) outcome measures were evaluated at 1, 4, 12 and 24 months. Need for retreatment and complications, change in PSA level and health resources‐related costs of both procedures were recorded and compared.
Results
Baseline and peri‐operative variables were similar in the two groups. At 1, 4, 12 and 24 months, 117, 116, 99 and 96 patients, respectively, were evaluable. Regarding urinary outcome measures, there was no significant difference between the groups. The mean ± sd IPSS at 1 and 2 years was 7.1 ± 3 and 7.9 ± 2.9 (P = 0.8), respectively, after GL‐PVP and 6.3 ± 3.1 and 7.2 ± 2.8, respectively, after bipolar TUVP (P = 0.31). At 24 months, the mean difference in IPSS was 0.7 (95% confidence interval −0.6 to 2.3; P = 0.6). The median (range) postoperative PSA reduction was 64.7 (25–99)% and 65.9 (50–99)% (P = 0.006) after GL‐PVP, and 32.1 (28.6–89.7)% and 39.3 (68.8–90.5)% (P = 0.005) after bipolar TUVP, at 1 and 2 years, respectively. After 2 years, retreatment for recurrent bladder outlet obstruction was reported in eight (13.8%) and 10 (16.4%) patients in the GL‐PVP and bipolar TUVP groups, respectively (P = 0.8). The mean estimated cost per bipolar TUVP procedure was significantly lower than per GL‐PVP procedure after 24 months (P = 0.01).
Conclusions
In terms of symptom control, bipolar TUVP was not inferior to GL‐PVP at 2 years. Durability of the outcome needs to be tracked. The greater cost of GL‐PVP compared with bipolar TUVP is an important concern.
lymph node, 5 mixed and 1 had soft tissue metastases. The MTD of VERU-111 is 72mg (3 /11 men had Grade 3 diarrhea). No Grade 3 diarrhea was observed at doses <72 mg per day. At doses < 72mg/d, the most common AEs were mild to moderate nausea, vomiting, diarrhea, and fatigue, with no observed neurotoxicity or neutropenia. Antitumor activity was assessed by PSA and bone/CT scans in men that were treated for 4 continuous 21-day cycles. 5/8 (63%) had PSA declines: 4 (50%) men had 30% and 2(25%) 50% declines compared to their 21 day cycle baseline. Based on PCWG3/RECIST 1.1 criteria, objective tumor responses were seen in 2 men (soft tissue and bone) and 5/8 (63%) had stable disease. Objective responses and PSA declines lasted > 12 weeks. Median duration of response has not been reached as 7/ 8 of the men are still being treated on study with a current duration of 10 months (6-15 months) and three additional men have not yet completed 4 continuous 21-day cycles.
Conclusions:The phase 1b portion demonstrates that oral VERU-111 has a favorable safety profile allowing for chronic administration and significant/durable antitumor activity. The daily dose of 63mg is being tested in the phase 2 portion. Oral administration, safe long-term treatment and evidence of antitumor activity highlight a potential prominent role of VERU 111 for the treatment of men with mCRPC who failed an androgen blocking agent.Clinical trial identification: NCT03752099.
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