PCA3 proved a useful tool in identifying patients at risk for prostate cancer before initial prostate biopsy. To our knowledge this is the largest PCA3 study in the initial biopsy population. These results suggest that further exploration of the value of PCA3 is warranted.

The Optilume ® Drug Coated Balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures. Materials and Methods: Eligibility criteria were: adult men with anterior strictures ≤12F in diameter and ≤3cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11, and maximum flow rate <15 mL/sec. 127 subjects were enrolled at 22 sites. The primary study endpoint was anatomic success (≥14F by cystoscopy or calibration) at 6 months. Key secondary endpoints included freedom from repeat treatment, International Prostatic Symptom Score (IPSS), and peak flow rate (Qmax). The primary safety endpoint included freedom from serious device or procedure related complications. Results: Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7cm. Anatomic success for Optilume DCB was significantly higher than Control at 6 months (75% vs 27%, p<0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequently adverse events included urinary tract infection, postprocedural hematuria, and dysuria. Conclusions: The results of this randomized controlled trial support that Optilume is safe and superior to standard DVIU/dilation for the treatment of recurrent anterior urethral strictures <3cm in length. The Optilume DCB may serve as an important alternative for men that have had an unsuccessful DVIU/dilation but want to avoid or delay urethroplasty.

PCA3 was found to be a better predictor of prostate cancer than PSA in the total population as well as the initial biopsy population, but was not superior to PSA in the repeat biopsy population. Prostate 73: 48-53, 2013. © 2012 Wiley Periodicals, Inc.

Primary chemoablation of low-grade intermediate-risk non-muscle-invasive bladder cancer using UGN-102, a mitomycin-containing reverse thermal gel (OPTIMA II): a phase 2b, open-label, single-arm trial,