Background and purpose: The refinement in the localization of prostate cancer tumor foci through transperineal template-mapping biopsies and MRI has led to an increased interest in lesion-directed focal prostatic cryoablation. Data are lacking, however, that compare the outcomes of whole-gland (WG) to focal ablation therapy (FT). The aim of our study was to assess both oncologic and functional outcomes between WG and FT cryoablation of the prostate after having matched patients for preoperative characteristics.
Patients and methods: We matched with a 1:1 ratio 317 men who underwent FT with 317 who underwent WG treatment in the Cryo Online Data (COLD) registry between 2007 and 2013. All patients were low-risk according to the D'Amico risk groups and were matched according to age at surgery. We only included preoperatively potent men. Oncologic outcomes were biochemical recurrence (BCR) free-survival defined according to the American Society for Radiation Oncology (ASTRO) and Phoenix criteria and assessed by Kaplan-Meier curves. Only patients with prostate-specific antigen (PSA) nadir data were included in oncologic outcome analysis. Functional outcomes were assessed at 6, 12, and 24 months after the procedure for erectile function (defined as ability to have intercourse with or without erectile aids), urinary continence, urinary retention, and rates of fistula formation.
Results: Median age at the time of the procedure was 66.5 years (standard deviation [SD] 6.6 y), and median follow-up time was 58.3 months. After surgery, 30% (n=95) and 17% (n=55) of the men who received WG and FT, respectively, underwent biopsy, with positive biopsy rates of 11.6% and 14.5%, respectively. BCR-free survival rates at 60 months according to the Phoenix definition were 80.1% and 71.3% in the WG and FT cohorts, respectively, with a hazard ratio of 0.827; according to the ASTRO definition, they were 82.1% and 73%, respectively (all P ≥ 0.1). Erectile function data at 24 months was available for 172 WG and 160 FT treated men. Recovery of erection was achieved in 46.8% and 68.8% of patients in the WG and FT cohorts, respectively (P=0.001). Urinary function data at 24 months was available for 307 WG and 313 FT patients. Continence rates were 98.7% and 100% for WG and FT groups, respectively (P=0.02). Urinary retention at 6, 12, and 24 months was reported in 7.3%, 1.9%, and 0.6%, respectively, in the WG arm, and in 5%, 1.3%, and 0.9%, respectively, in the FT arm. Finally, only one fistula was reported in each group.
Conclusions: Men with low-risk prostate cancer who underwent FT cryoablation had comparable BCR-survival rates at 60 months to patients treated with WG. However, FT patients had higher erectile function preservation rates at 24 months post-procedure. Urinary continence, retention and fistula rates were similar between the two treatment groups.