A Parallel Randomized Clinical Trial Examining the Return of Urinary Continence After Robot- Assisted Radical Prostatectomy with or without a Small Intestinal Submucosa Bladder Neck Sling

Purpose Urinary continence is a driver of quality of life after radical prostatectomy. In this study we evaluated the impact of a biological bladder neck sling on the return of urinary continence after robot-assisted radical prostatectomy. Materials and Methods This study compared early continence in patients undergoing robot-assisted radical prostatectomy with a sling and without a sling in a 2-group, 1:1, parallel, randomized controlled trial. Patients were blinded to group assignment. The primary outcome was defined as urinary continence (0 to 1 pad per day) at 1 month postoperatively. Inclusion criteria were organ confined prostate cancer and a prostate specific antigen less than 15 ng/ml. Exclusion criteria were any prior surgery on the prostate, a history of neurogenic bladder and history of pelvic radiation. A chi-squared test was used for the primary outcome. Results A total of 147 patients were randomized (control 74, sling 73) and 92% were available for primary end point analysis at 1 month. There were no significant differences in baseline or perioperative data except that operating room time was 20.1 minutes longer for the sling group (p=0.04). The continence rate was similar between the control and sling groups at 1 month (47.1% vs 55.2%, p=0.34) and 12 months (86.7% vs 94.5%, p=0.15), respectively. Adverse events were similar between the control and sling groups (10.8% vs 13.7%, p=0.59). Conclusions The application of an absorbable urethral sling at robot-assisted radical prostatectomy was well tolerated with no increase in obstructive symptoms in this randomized trial. However, the sling failed to show a significant improvement in continence

Impact of CCP test on personalizing treatment decisions: Results from a prospective registry of newly diagnosed prostate cancer patients

63 Background: The cell cycle progression (CCP) test is a validated molecular assay that assesses risk of prostate cancer−specific disease progression and mortality when combined with standard clinicopathologic parameters. PROCEDE−1000 is the largest prospective registry to evaluate CCP test impact on personalizing prostate cancer treatment. Results of an interim analysis are presented. Methods: Untreated patients with newly diagnosed (≤6 months), clinically localized prostate adenocarcinoma were enrolled (n=816). The physician’s initial therapy recommendation (pre−CCP) was recorded on the first questionnaire. The CCP test was then conducted on prostate biopsy tissue. Three post−CCP questionnaires recorded the physician’s revised treatment recommendation, physician/patient treatment decision, and actual treatment administered. Changes in treatments between the pre-CCP and post−CCP questionnaires demonstrated the impact of CCP testing on treatment decisions at each stage. Results: Visual analog scale measurements indicated a significant increase (p=0.0125) in the physician’s likelihood of recommending non−interventional treatment post−CCP test; there was an increase in active surveillance from the initial interventional therapy recommendation. From pre−CCP therapy recommendation, the CCP score caused a change in actual treatment administered in 44% of patients; 72% of changes were reductions in treatment. Reductions occurred in radical prostatectomy (27%), radiation therapy (44% primary; 56% adjuvant), brachytherapy (46% interstitial; 66% HDR) and hormonal therapy (33% neoadjuvant; 68% concurrent) treatments. While 35.9% of patients were recommended for conservative management pre−CCP testing, there was a 6.5% increase in non−interventional treatments during actual follow−up. Overall, there was a significant reduction in the number of treatment options at each successive evaluation (p<0.0001). Conclusions: The CCP risk assessment score has a significant impact in helping physicians and patients reach consensus on an appropriate personalized treatment decision, often with major reductions in interventional treatment burden. Clinical trial information: NCT01954004