mpMRI-US Fusion-Guided Targeted Cryotherapy in Patients with Primary Localized Prostate Cancer: A Prospective Analysis of Oncological and Functional Outcomes

Abstract

Targeted therapy (TT) for prostate cancer (PCa) aims to ablate the malignant lesion with an adequate margin of safety in order to obtain similar oncological outcomes, but with less toxicity than radical treatments. The main aim of this study was to evaluate the recurrence rate (RR) in patients with primary localized PCa undergoing mpMRI/US fusion targeted cryotherapy (FTC). A secondary objective was to evaluate prostate-specific antigen (PSA) as a predictor of recurrences. We designed a prospective single-center single-cohort study. Patients with primary localized PCa, mono or multifocal lesions, PSA ≤ 15 ng/mL, and a Gleason score (GS) ≤ 4 + 3 undergoing FTC were enrolled. RR was chosen as the primary outcome. Recurrence was defined as the presence of clinically significant prostate cancer in the treated areas. PSA values measured at different times were tested as predictors of recurrence. Continuous variables were assessed with the Bayesian t-test and categorical assessments with the chix-squared test. Univariate and logistic regression assessment were used for predictions. A total of 75 cases were included in the study. Ten subjects developed a recurrence (RR: 15.2%), while fifty-six (84.8%) patients showed a recurrence-free status. A %PSA drop of 31.5% during the first 12 months after treatment predicted a recurrence with a sensitivity of 53.8% and a specificity of 79.2%. A PSA drop of 55.3% 12 months after treatment predicted a recurrence with a sensitivity of 91.7% and a specificity of 51.9%. FTC for primary localized PCa seems to be associated with a low but not negligible percentage of recurrences. Serum PSA levels may have a role indicating RR.

Minimally Invasive Treatment in Benign Prostatic Hyperplasia (BPH)

“…MRI-guided partial cryoablation has already been approved for the treatment of intermediate-risk prostate cancer. 60–62…”

“…57 Cryoablation MRI-guided partial cryoablation has already been approved for the treatment of intermediate-risk prostate cancer. [60][61][62] Selected cases of BPH may also benefit from the employment of this technique, endowed with fewer risks than generalized cryoablation, such as erectile dysfunction, incontinence, and recto-urethral fistulas by targeting only the part of the gland that causes urinary symptoms.…”

Image-Guided Prostate Cryoablation: State-of-the-Art

“…While ablation approaches have improved in recent years from whole gland approaches to more hemi-gland and focal approaches, the majority of the published image-guided approaches utilize ultrasound guidance in the operating room. In other cases, MRI/US fusion is employed, but needle or probe placement and thermal monitoring are performed with the use of ultrasound guidance [ 25 , 42 ].…”

“…Much of the research to date has involved relatively small numbers of patients and retrospective analyses ( Table 1 ). However, a recent prospective single-arm study by Fernández-Pascual et al enrolled 75 patients with between one and three lesions targeted for treatment [ 42 ]. Treatment planning software was used, together with ultrasound and cryoablation, for the treatment of biopsy-confirmed prostate cancer.…”

Role of Image-Guided Focal Cryoablation in Localized Prostate Cancer

“…Has all of the following: 18 While exact consensus for patient selection has not been achieved (namely whether Gleason Grade Group (GG) 3 patients should be routinely offered focal ablation vs. restricting this approach to grade groups 1-2), it is generally recognized that NCCN ® high-risk patients (i.e., GG4-5) are not suitable candidates for this treatment approach. 8,19 In addition, patients with solitary MRI visible lesions are best suited for focal cryotherapy, 8 with systematic template biopsy demonstrating no other areas of clinically significant prostate cancer (csPCa; i.e., >GG1).…”