Prolonged PSA stabilization and overall survival following sipuleucel-T monotherapy in metastatic castration-resistant prostate cancer patients.

BACKGROUND: Sipuleucel-T is an autologous cellular immunotherapy that is FDA approved for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC). The IMPACT registry trial demonstrated a 4.1 month survival benefit, but not a consistent PSA response or improvement in progression-free survival. Based upon several factors, including this lack of objective treatment response, sipuleucel-T has been under-utilized in this patient population, despite current NCCN recommendations. METHODS: In order to explore if delayed treatment response occurs in a subset of patients, we performed a single institutional retrospective analysis of mCRPC patients treated with sipuleucel-T and ongoing ADT alone. Within that group, we then identified a subset of sipuleucel-T-treated men with long-term disease control and no additional interventions. To independently confirm this finding, we evaluated a total of 336 patients from 4 large urology group practices treated with sipuleucel-T between 2010 and 2014 and identified 44 patients who met the same criteria and demonstrated evidence of PSA stabilization post sipuleucel-T treatment. RESULTS: For this subgroup of patients, 79% (95% CI: 64.5%, 88.1%) survived 36 months with a median time to subsequent therapy of 17.8 months (95% CI 10.3, 25.3). CONCLUSIONS: Although patient selection could account for some or all of these results, these data support the utilization of sipuleucel-T alone in select mCRPC patients that is associated with a delay in disease progression and a good overall prognosis.

Prospective multi-center study elucidating patient experience after prostatic urethral lift.

INTRODUCTION: The prostatic urethral Lift (PUL) procedure offers a novel treatment for men with lower urinary tract obstructive symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Most patients who seek LUTS/BPH treatment choose the intervention that offers the expectations of a significant improvement in quality of life and the least chance of short or long term morbidity. We report the results of a prospective, non-randomized study designed to further characterize the perioperative subject experience with the PUL procedure. MATERIALS AND METHODS: The PUL procedure employs permanent implants to mechanically pull the prostatic lateral lobes apart. Subjects were ≥ 50 years old with International Prostate Symptom Score (IPSS) ≥ 12, peak flow rate ≤ 12 mL, and prostate volume between 30 cc and 80 cc. Subject experience through 1 month was characterized by validated instruments designed to assess quality of recovery, work productivity, activity impairment, symptom response, quality of life, flow rate and sexual function. RESULTS: Fifty-one subjects were treated without any serious adverse events. No case was abandoned or postponed due to subject discomfort. By 1 month, 86% of subjects achieved high quality recovery as measured by a score of ≥ 80 on the Quality of Recovery Visual Analog Scale. Ninety percent of subjects reported improvement in their condition and 75% of subjects would recommend the procedure to a friend. Symptom response, flow rate improvement, and sexual function preservation were comparable to published studies. CONCLUSIONS: The PUL procedure was tolerated under local anesthesia, rarely required postoperative catheterization, and offered rapid LUTS relief with minimal associated morbidity. The study further allows urologists to advise patients regarding post-procedural expectations and side effects, inclusive of symptomatic benefit.