High-Intensity Focused Ultrasound (HIFU) as salvage therapy for radio-recurrent prostate cancer: predictors of disease response

ABSTRACT Background Some men with localized radio-recurrent prostate cancer may benefit from salvage high-intensity focused ultrasound (HIFU). Herein, we describe oncologic outcomes and predictors of disease response after salvage whole gland HIFU from our prospective cohort. Materials and Methods Patients with localized radio-recurrent prostate cancer were prospectively enrolled from January 2005 to December 2014. Participants had to meet both biochemical and histological definitions of recurrence. Exclusion criteria included the receipt of prior salvage therapy, presence of metastatic disease, and administration of ADT in the 6-months prior to enrollment. Participants were treated with a single session of whole-gland HIFU ablation with the AblathermTM device (EDAP, France). The primary endpoint was recurrence-free survival (RFS), defined as a composite endpoint of PSA progression (Phoenix criteria), receipt of any further salvage therapy, receipt of ADT, clinical progression, or death. Kaplan-Meier survival analysis was used to determine the primary end-point and stratifications were used to determine the significance of 6 pre-specified predictors of improved RFS (TRUS biopsy grade, number of study entry TRUS biopsy cores positive, palpable disease at study enrollment, pre-HIFU PSA, an undetectable post-HIFU PSA nadir, and receipt of prior hormone therapy). Survival analysis was performed on participants with a minimum of 1-year follow-up. Results Twenty-four participants were eligible for study inclusion with a median follow-up of 31.0 months. Median PSA at study entry was 4.02ng/ml. Median time to PSA nadir was 3 months after treatment and median post-HIFU PSA nadir was 0.04ng/ml. Median 2-year and 5-year RFS was 66.3% and 51.6% respectively. Of our 6 prespecified predictors, an undetectable PSA nadir was the only significant predictor of improved RFS (HR 0.07, 95% CI 0.02-0.29, log-rank P<0.001). One participant underwent an intervention for a urethral stricture. No participants developed osteitis pubis or rectourethral fistulae. Conclusions Salvage HIFU allows for disease control in selected patients with localized radio-recurrent prostate cancer. An undetectable PSA nadir serves as an early predictor of disease response.

Towards development and validation of an intraoperative assessment tool for robot-assisted radical prostatectomy training: results of a Delphi study

ABSTRACT Introduction As urology training shifts toward competency-based frameworks, the need for tools for high stakes assessment of trainees is crucial. Validated assessment metrics are lacking for many robot-assisted radical prostatectomy (RARP). As it is quickly becoming the gold standard for treatment of localized prostate cancer, the development and validation of a RARP assessment tool for training is timely. Materials and methods We recruited 13 expert RARP surgeons from the United States and Canada to serve as our Delphi panel. Using an initial inventory developed via a modified Delphi process with urology residents, fellows, and staff at our institution, panelists iteratively rated each step and sub-step on a 5-point Likert scale of agreement for inclusion in the final assessment tool. Qualitative feedback was elicited for each item to determine proper step placement, wording, and suggestions. Results Panelist's responses were compiled and the inventory was edited through three iterations, after which 100% consensus was achieved. The initial inventory steps were decreased by 13% and a skip pattern was incorporated. The final RARP stepwise inventory was comprised of 13 critical steps with 52 sub-steps. There was no attrition throughout the Delphi process. Conclusions Our Delphi study resulted in a comprehensive inventory of intraoperative RARP steps with excellent consensus. This final inventory will be used to develop a valid and psychometrically sound intraoperative assessment tool for use during RARP training and evaluation, with the aim of increasing competency of all trainees.