Patient‐reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy‐monitored study

Abstract

Introduction: We report herein the impact of focal therapy (FT) on multi-domain functional outcomes in a Phase II prospective clinical trial (NCT04138914) in focal cryotherapy for clinically significant prostate cancer (csPCa).Methods: The primary outcome was the detection of a ≥5 point deterioration in any of the four main expanded prostate index composite (EPIC) functional domains.Pretreatment multiparametric magnetic resonance imaging (mpMRI) and transperineal targeted and systematic saturation biopsy were used to select patients with prostate-specific antigen (PSA)≤20 ng/mL, Gleason grade group (GG) ≤4, mpMRI lesion volume ≤ 3 mL (for a single lesion) or ≤1.5 mL (where two lesions were present). Focal cryotherapy was performed with a minimum 5 mm margin around each target lesion. EPIC scores were obtained at baseline and posttreatment at 1, 3, 6, and 12 months. Mandatory repeat mpMRI and prostate biopsy were performed at 12 months to determine the infield and outfield recurrence.Results: Twenty-eight patients were recruited. The mean age was 68 years, with PSA of 7.3 ng/mL and PSA density of 0.19 ng/mL 2 . No Clavien-Dindo ≥3 complications occurred. Transient worsening of EPIC urinary (mean diff 16.0, p < 0.001, 95% confidence interval [

Role of Image-Guided Focal Cryoablation in Localized Prostate Cancer

“…29 A more recent study found that, at 12-month follow-up mpMRI and biopsy, 22 of 28 patients (78.6%) had no detectable clinically significant prostate cancer. 30 In a 2023 prospective study by Aker et al, n=143 patients diagnosed with unilateral clinically significant prostate cancer were enrolled in an observational trial of partial gland cryotherapy between 2017 and 2019 at UCLA Medical Center. 31 Participants underwent MRI-guided biopsy (MRGB) assessments at the beginning of the study and at 6 months and 18 months following the treatment.…”

“…27 Studies suggest that complementary mpMRI with mandatory repeat biopsy provides the most comprehensive assessment of oncological outcomes after focal therapy. 27,30 Role of Image-Guided Focal Cryoablation in Localized Prostate Cancer…”