MP18-13 PRIMARY FOCAL CRYOTHERAPY IN THE TREATMENT OF PREDOMINANTLY ANTERIOR AND HIGH VOLUME INTERMEDIATE AND HIGH-RISK LOCALIZED PROSTATE CANCER IN THE UK

Abstract

INTRODUCTION AND OBJECTIVES: Focal cryotherapy may offer good oncological outcomes with minimal side-effects. We recently commenced a focal cryotherapy program, primarily for anterior or transition zone lesions, to complement our focal HIFU programme. We assessed safety, adverse-events, functional outcomes and disease control. METHODS: Between October 2013 and June 2015, 56 patients underwent primary focal cryotherapy. All had pre-operative prostate multi-parametric MRI followed by transperineal template mapping or MRI-targeted biopsy. Patient reported outcome measures (PROMs) (IPSS, EPIC, IIEF-15) were collected prospectively, preand for up to 1 year post-operatively. Follow-up consisted of PSA blood tests and mpMRI at 12 months. Failure was defined as transition to radical or systemic therapy. A redo focal cryotherapy approach was permitted based on a positive post-focal cryotherapy mpMRI indicating residual in-field disease. Out-of-field disease progression could be treated by further focal cryotherapy but was defined as (staging) failure for purpose of this analysis. RESULTS: The median age, follow-up, prostate volume, PSA density and pre-operative PSA were 68 years, 13 months [5-24], 45cc, 0.24ng/ml/cc and 12ng/ml respectively. 38% were NCCN high-risk, 61% intermediate-risk and 1% low-risk (high-volume Gleason 6 disease). 15 (27%) underwent pre-operative cytoreduction with biclutamide. Their median post-operative PSA drop was 92% to 0.9ng/ml. Median post-operative PSA drop in the remaining 41 patients was 83% to 1.75ng/ml. Failure as defined by progression to radical therapy occurred in 1 patient (2%). 5 (9%) required further focal therapy: 2 (3.5%) had in-field residual disease whilst 3 (5.5%) had out-of-field disease detected on follow-up imaging. 48/56 patients (84%) returned at least 1 PROMs questionnaire. Mild post-operative incontinence requiring 1 pad/day occurred in 3 (5%) at 3-9 months, although at 12 months, none (0%) required padusage. Baseline median IIEF-15 was 36.5, with 5/48 patients (11%) taking PDE5i for pre-existing ED. Post-operatively median IIEF-15 decreased to 23 at 3 months before improving to 31.5 at 6 months and 28 at 9 and 12 months. 10/43 patients (23%) who were not previously on ED treatment were started on PDE5i. Overall 24/48 (50%) had erections sufficient for intercourse pre-operatively and 15/24 (37.5%) still had ED at last follow-up. Median IPSS scores improved from 8 pre-operatively to 5 at 12 months with a mild improvement in their QoL score from 2 to 1. Other adverse-events occurred in 11/56 patients (20%): 4 (7%) urinary retentions, 2 (3.5%) UTI’s, 2 (3.5%) urinary retention and UTI, 2 (3.5%) haematuria and 1 (2%) penile-tip numbness. CONCLUSIONS: In our study, predominated by large anterior intermediate and high risk lesions, focal primary cryotherapy confers low rates of side-effects, with a 0% 12-month incontinence rate and a 37.5% ED rate. Early oncological outcomes show a retreatment rate of 9% and conversion to radical treatment in only 2%. Continued follow-up will determine the medium to long-term disease control.