Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: We present final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor therapy (Rezum™) for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 197 subjects >50 years of age with International Prostate Symptom Score ≥13, maximum flow rate ≤15 ml/second and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the control arm of 61 subjects, a subset of 53 subjects requalified and after 3 months received treatment as part of the crossover group and were also followed for 5 years. The total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion. RESULTS: Significant improvement of lower urinary tract symptoms was observed at <3 months post-thermal therapy, remaining durable through 5 years in the treatment group (International Prostate Symptom Score reduced 48%, quality of life increased 45%, maximum flow rate improved 44%, Benign Prostatic Hyperplasia Impact Index decreased 48%). Surgical re-treatment rate was 4.4% with no reports of device or procedure related sexual dysfunction or sustained de novo erectile dysfunction. Results within the crossover group were similar through 5 years. CONCLUSIONS: Minimally invasive treatment with water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical re-treatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes.

Comparative Effectiveness of Transurethral Prostate Procedures at Enabling Urologic Medication Discontinuation: A Retrospective Analysis.

OBJECTIVE: To test the hypothesis that transurethral prostate procedures (TUPPs) eliminating tissue result in greater medication discontinuation and lower de novo initiation rates than procedures inducing tissue necrosis. METHODS: Retrospective review of all men undergoing first time TUPPs at a large tertiary center from 2001 to 2016 was completed. Procedure type and urologic medication use before, 3-12 months after, and greater than 12 months after TUPP were analyzed with simple open prostatectomy as a comparator. Tissue-eliminating TUPPs included transurethral resection of the prostate and laser prostatectomy. Tissue-necrosing procedures included microwave therapy (transurethral microwave therapy) and radiofrequency ablation (transurethral needle ablation), which were grouped in analyses. Medication types were 5-alpha reductase inhibitors (5ARI), alpha blockers, anticholinergics, and beta-3 agonists (B3A). RESULTS: A total 5150 TUPPs were analyzed. Preoperative medication use significantly varied across TUPPs for 5ARI (P <.01), alpha-blockers (P .01), and anticholinergics (P .047), but not B3A (P .476). Transurethral resection of the prostate and laser prostatectomy were associated with significantly higher medication discontinuation rates and lower resumption and initiation rates compared to tissue-necrosing procedures. Relative to TUPPs, simple prostatectomy had significantly higher medication discontinuation, as well as the lowest resumption and initiation rates. CONCLUSION: Tissue-eliminating benign prostatic hyperplasia procedures were associated with better medication discontinuation, resumption, and de novo initiation rates compared to tissue-necrosing benign prostatic hyperplasia procedures.

Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: This report reveals the results of a multicenter, randomized, controlled study using transurethral prostate convective water vapor thermal energy to treat lower urinary tract symptoms associated with benign prostatic hyperplasia. MATERIALS AND METHODS: Men 50 years old or older with an International Prostate Symptom Score of 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezum® System and control. Thermal water vapor was injected into the transition zone and median lobe as needed. The control procedure was rigid cystoscopy with simulated active treatment sounds. The primary end point compared International Prostate Symptom Score reduction at 3 months. Treatment subjects were followed for 12 months. RESULTS: There were 197 men randomized (active 136, control 61). Thermal therapy and control International Prostate Symptom Score was reduced by 11.2 ± 7.6 and 4.3 ± 6.9 respectively (p <0.0001). Treatment subject baseline International Prostate Symptom Score of 22 decreased at 2 weeks (18.6, p=0.0006) and by 50% or greater at 3, 6 and 12 months, p <0.0001. The peak flow rate increased by 6.2 ml per second at 3 months and was sustained throughout 12 months (p <0.0001). No de novo erectile dysfunction was reported. Adverse events were mild to moderate and resolved quickly. CONCLUSIONS: Convective water vapor thermal therapy provides rapid and durable improvements in benign prostatic hyperplasia symptoms and preserves erectile and ejaculatory function. Treatment can be delivered in an office or hospital setting using oral pain medication and is applicable to all prostate zones including the median lobe.

Long-Term Efficacy and Toxicity of Low-Dose-Rate ¹²5I Prostate Brachytherapy as Monotherapy in Low-, Intermediate-, and High-Risk Prostate Cancer.

PURPOSE/OBJECTIVES: To report long-term efficacy and toxicity for a single-institution cohort of patients treated with low-dose-rate prostate brachytherapy permanent implant (PI) monotherapy. METHODS AND MATERIALS: From 1996 to 2007, 1989 patients with low-risk (61.3%), intermediate-risk (29.8%), high-intermediate-risk (4.5%), and high-risk prostate cancer (4.4%) were treated with PI and followed up prospectively in a registry. All patients were treated with (125)I monotherapy to 144 Gy. Late toxicity was coded retrospectively according to a modified Common Terminology Criteria for Adverse Events 4.0 scale. The rates of biochemical relapse-free survival (bRFS), distant metastasis-free survival (DMFS), overall survival (OS), and prostate cancer-specific mortality (PCSM) were calculated. We identified factors associated with late grade ≥3 genitourinary (GU) and gastrointestinal (GI) toxicity, bRFS, DMFS, OS, PCSM, and incontinence. RESULTS: The median age of the patients was 67 years, and the median overall and prostate-specific antigen follow-up times were 6.8 years and 5.8 years, respectively. The overall 5-year rates for bRFS, DMFS, OS, and PCSM were 91.9%, 97.8%, 93.7%, and 0.71%, respectively. The 10-year rates were 81.5%, 91.5%, 76.1%, and 2.5%, respectively. The overall rates of late grade ≥3 GU and GI toxicity were 7.6% and 0.8%, respectively. On multivariable analysis, age and prostate length were significantly associated with increased risk of late grade ≥3 GU toxicity. The risk of incontinence was highly correlated with both pre-PI and post-PI transurethral resection of the prostate. CONCLUSIONS: Prostate brachytherapy as monotherapy is an effective treatment for low-risk and low-intermediate-risk prostate cancer and appears promising as a treatment for high-intermediate-risk and high-risk prostate cancer. Significant long-term toxicities are rare when brachytherapy is performed as monotherapy.

Outcomes after photoselective vaporization of the prostate and transurethral resection of the prostate in patients who develop prostatic obstruction after radiation therapy.

OBJECTIVE: To compare the need for repeat treatment or urinary diversion in patients undergoing transurethral resection of the prostate (TURP) compared with photoselective vaporization of the prostate (PVP) after brachytherapy or external beam radiation therapy (EBRT). METHODS: The prostate cancer database of Cleveland Clinic includes 3600 patients who have undergone prostate brachytherapy and 2500 patients who have undergone EBRT. We cross-referenced these patients with the electronic medical record to identify patients who required PVP or TURP after radiation. The primary outcome was the need for any further intervention after PVP or TURP, including bladder neck incision, repeat TURP, or permanent supravesicular diversion. RESULTS: Sixty of the 3600 patients (1.7%) required prostate reduction surgery after brachytherapy. Of these 60 patients, 19 of 40 (47.5%) who underwent TURP required further intervention, and 10 of 20 patients (50%) who underwent PVP required subsequent intervention. Twenty-eight of the 2500 patients (1.1%) required prostate reduction surgery after EBRT. Of these 28 patients, 5 of 18 patients (27.8%) who underwent TURP required further intervention, and 5 of 10 patients (50%) who underwent PVP required subsequent intervention. Following either type of radiation there was not a significant difference in the need for further treatment based on the type of surgery (P >.999 for brachytherapy; P = .412 for EBRT). The median time between radiation and prostate reduction surgery is 20.2 months (range, 14.6-27.6) after brachytherapy and 53.3 months (range, 27.5-53.3) after EBRT (P = .0005). CONCLUSION: This study suggests that PVP and TURP are comparable in treating prostatic obstruction after brachytherapy or EBRT. However, obstruction after brachytherapy occurs earlier compared with after EBRT.

Five year biochemical recurrence free survival for intermediate risk prostate cancer after radical prostatectomy, external beam radiation therapy or permanent seed implantation.

OBJECTIVE: To compare biochemical recurrence-free survival (bRFS) for patients with intermediate-risk prostate cancer treated by retropubic radical prostatectomy (RRP), laparoscopic radical prostatectomy (LRP), external beam radiation therapy (RT), or permanent seed implantation (PI). METHODS: Patients treated for intermediate-risk prostate cancer per National Comprehensive Cancer Network guidelines from 1996 to 2005 were studied. Variables potentially affecting bRFS were examined using univariate and multivariate Cox regression analysis. Five-year bRFS rates were calculated by actuarial methods; bRFS was calculated using Kaplan-Meier analysis. Nadir +2 definition of biochemical failure was used for RT and PI patients; a PSA ≥ 0.4 ng/mL was used for radical prostatectomy (RP) patients. Time to initiation of salvage therapy was compared for each treatment group using the Kruskal-Wallis test. RESULTS: Nine-hundred seventy-nine patients were analyzed with a median follow-up of 65 months. Five years bRFS rate was 82.8% for all patients (89.5% PI, 85.7% RT, 79.9% RRP, and 60.2% LRP). Patients treated by LRP had significantly worse bRFS than RT (P < .0001), PI (P < .0001), or RRP patients (P = .0038). Treatment modality (P < .0001) and average number of PSA tests per year (P < .0001) were the only independent predictors of bRFS on multivariate analysis. Median time to initiation of salvage therapy from time of treatment was 28.6 months for all patients (26.1 RP, 21.0 LRP, 47.4 PI, 47.8 RT; P < .0001). CONCLUSIONS: Patients with intermediate-risk prostate cancer choosing PI, RT, or RRP appear to have improved 5-year bRFS and delayed salvage therapy compared with LRP.

Transurethral microwave thermotherapy effectiveness in small prostates.

OBJECTIVES: To dispel the misconceptions that patients with small prostates react differently than patients with larger prostates to cooled transurethral microwave thermotherapy. Cooled transurethral microwave thermotherapy has developed into a valid alternative to treat men with lower urinary tract symptoms due to benign prostatic hyperplasia. However, doubts still remain regarding the ability of this office-based technique to treat smaller prostates. METHODS: A database of 713 men from six previous studies using cooled transurethral microwave thermotherapy devices developed by Urologix were combined for this analysis. The data were analyzed to determine whether the baseline prostate size had a significant effect on American Urological Association Symptom Index, peak flow rate, quality-of-life score, or symptom problem index. Follow-up intervals in this analysis include 6, 12, 24, 36, 48, and 60 months after therapy. Visual analog scale ratings during treatment were also assessed. General linear models and repeated measures analyses were performed. RESULTS: Statistical analysis showed no effect of baseline prostate size on treatment outcomes for more than 5 years. Visual analog scale measurements were also not affected by the baseline prostate size. CONCLUSIONS: Transurethral microwave thermotherapy appears to be as efficacious in treating patients with small prostates as those with large prostates and should be offered as a treatment modality to patients with prostates of all sizes.