Early-Medium-Term Outcomes of Primary Focal Cryotherapy to Treat Nonmetastatic Clinically Significant Prostate Cancer from a Prospective Multicentre Registry.

BACKGROUND: Focal cryotherapy can be used to treat patients with clinically significant nonmetastatic prostate cancer to reduce side effects. OBJECTIVE: Early-medium-term cancer control and functional outcomes. DESIGN, SETTING, AND PARTICIPANTS: A prospective registry-based case series of 122 consecutive patients undergoing focal cryotherapy between October 1, 2013, and November 30, 2016, in five UK centres. Median follow-up was 27.8mo [interquartile range (IQR) 19.5-36.7]. A total of 35 patients (28.7%) had National Comprehensive Cancer Network (NCCN) high risk and 87 (71.3%) had intermediate risk disease. Risk and zonal stratification included multiparametric magnetic resonance imaging (mpMRI) with targeted and systematic biopsies, or transperineal mapping biopsies. INTERVENTION: Focal cryoablation of MR-visible tumours. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Follow-up involved prostate-specific antigen (PSA) monitoring, mpMRI, and for-cause biopsies. Primary outcome was failure-free survival (FFS), defined as transition to radical, whole-gland, or systemic therapy, or metastases/death. Secondary outcomes included adverse events and functional outcomes. RESULTS AND LIMITATIONS: A total of 80 (65.6%) had anterior ablation, 23 (19.7%) combined posterior and anterior ablation, and two (1.6%) posterior ablation alone (SeedNet or Visual-ICE, BTG plc). Median age was 68.7yr (IQR 64.9-73.8) and preoperative PSA 10.8ng/ml (IQR 7.8-15.6). Overall FFS at 3yr was 90.5% [95% confidence interval (CI) 84.2-97.3]. When stratified for the NCCN risk group, 3-yr outcomes were 84.7% (95% CI 71.4-100) in high risk and 93.3% (95% CI 86.8-100) in intermediate risk. At last follow-up, incontinence defined as any pad use was 0/69 (0%) and erectile dysfunction (defined as erections insufficient for penetration) was 5/31 (16.1%). Limitations include lack of long-term outcomes. CONCLUSIONS: Focal cryotherapy primarily for anterior intermediate and high-risk prostate cancer results in good rates of cancer control and low rates of treatment-related side effects. PATIENT SUMMARY: In this multicentre study of 122 patients undergoing focal cryotherapy for medium- to high-risk prostate cancer, at 3yr, no patient died from their cancer whilst failure-free survival, was approximately 90%. None of the patients needed pads for managing urine leakage, although 16% had erection problems.

Onabotulinum toxin A Injections in Men With Refractory Idiopathic Detrusor Overactivity.

OBJECTIVE: To establish the effectiveness and safety profile of Onaboulinum toxin A (BTX-A) in men with idiopathic detrusor overactivity and compare with the outcomes observed in women. Several randomized trials have demonstrated the effectiveness of intradetrusor BTX-A injections in improving symptoms and quality of life in patients with overactive bladder (OAB) symptoms. Most trials however contained relatively few men or excluded men altogether. MATERIALS AND METHODS: Data patient undergoing BTX-A for refractory OAB with idiopathic detrusor overactivity on urodynamics were extracted from our center's prospectively maintained database. Incontinence impact questionnaire-7 and urogenital distress inventory-6 scores were collected at baseline and 4-12 weeks together with data regarding urinary retention requiring clean intermittent self-catheterization (CISC) and urinary tract infection (UTI). Urodynamic studies were assessed where available to see if voiding dysfunction and CISC were predictable. RESULTS: Sixty-five men received 133 BoNT-A treatments in the 15-year period representing 27.8% of those with refractory OAB. Baseline urogenital distress inventory-6 and incontinence impact questionnaire-7 fell by 4.2 (P = .00) and 6.0 (P = .00) points for men and by 6.0 (P = .00) and 11.1 (P = .00) for women, respectively. De novo CISC was required in 46 (42.6%) men and 107 (35.3%) women (P = .10). UTI was reported in 36 (29.0%) men and 86 (27.0%) women (P = .73). The bladder outflow obstruction index and the bladder contractility index did not reliably predict CISC requirement. CONCLUSION: Men with refractory OAB experience significant improvement in quality of life scores following BTX-A, though the benefit appears greater in women. The requirements for CISC and UTI rates were similar between sexes.

A comparison of time taken to return to baseline erectile function following focal and whole gland ablative therapies for localized prostate cancer: A systematic review.

OBJECTIVES: To systematically review erectile function (EF) outcomes following primary whole gland (WG) and focal ablative therapies for localized prostate cancer to ascertain whether the treatment modality or intended treatment volume affects the time taken to recover baseline EF. METHOD AND MATERIALS: A systematic review was performed according to the preferred reporting items for systematic review and meta-analysis statement. Inclusion criteria were men with localized prostate cancer treated with primary, ablative therapy. Primary outcome was the return to baseline EF measured with objective, validated symptoms scores. Secondary outcome was use of phosphodiesterase inhibitors or erectile aids. Meta-analysis was not performed owing to heterogenous outcome measures. RESULTS: Of 222 articles identified in February 2017, 55 studies which reported EF after ablative therapy were identified but only 17 used validated outcome measures and met inclusion criteria. WG cryotherapy was used in 2 studies, WG high-intensity focused ultrasound (HIFU) in 5, focal cryotherapy in 2, focal HIFU in 3, focal phototherapy or laser therapy in 4, vascular-targeted photodynamic therapy in 3, and irreversible electroporation in 2. WG cryotherapy was associated with a significant decline in EF at 6 months with minimal improvement at 36 months. Baseline IIEF-15 of patients undergoing focal HIFU fell 30 points at 1 month but returned to baseline by 6 months. The remaining focal therapies demonstrated minimal or no effect on EF, but the men in these studies had small foci of disease. The review is limited by lack of randomized studies and heterogenous outcome measures. CONCLUSIONS: Most studies assessing the outcomes of focal therapy on sexual function were not of high quality, used heterogenous outcomes, and had relatively short follow up, highlighting the need for more robustly designed studies using validated patient reported outcome measures  for comparison. However, FT in general resulted in less effect on EF than WG ablation.

Using imaging biomarkers to improve the planning of radical prostatectomies.

OBJECTIVES: This exploratory pilot study aimed to evaluate whether adding imaging biomarkers to conventional staging improves complete excision rates after undergoing radical prostatectomy (RP) in the United Kingdom for patients who have not undergone population prostate specific antigen screening. We primarily considered estimates of lesion volume and location based on computer-aided analysis of ultrasound (US) raw radiofrequency (RF) data acquired during trans-rectal ultrasound. The imaging analysis device used had been shown to accurately detect tumor loci within the prostate in previous studies. METHODS AND MATERIALS: US raw RF data were collected from motorized trans-rectal ultrasound of 68 consecutive men with operable prostate cancer. In this cohort (group 1), locations and volume measurements of lesions suspected of harboring cancer on US raw RF data analysis by prostate HistoScanning, were added to conventional presurgical staging.The unexposed control group comprised 100 men who underwent conventional presurgical staging only (group 2): 50 were operated before and 50 operated after group 1 recruitment. Changes to pre-operative surgical planning and positive lateral margins of RP prostate pathological specimens were the primary outcomes. Data were collected using a Microsoft Excel database and analyzed using Stata. RESULTS: Baseline demographics were comparable. In group 1, consideration of the additional imaging biomarkers led to changes in 27 (19.9%) operative surgical plans. Absolute rate reduction of a positive surgical margin (PSM) attributable to the imaging-biomarkers was 13.3% (P = 0.029). For stage pT3, PSM rate was reduced from 45.8% (n = 44) to 21.2% (n = 11) (P = 0.0028). CONCLUSIONS: Obtaining quantitative measurements of preoperative imaging biomarkers appears to improve PSM rates of patients undergoing RP. The greatest PSM rate reduction was observed for pT3 tumors.