To evaluate the oncological and functional outcomes of primary cryotherapy in men with clinically localized, high-grade prostate cancer.
We included all men with biopsy Gleason score ≥ 8, localized (cT1-2) disease with a serum PSA ≤50 ng/ml from the Cryo On-Line Data (COLD) registry.
The primary outcome was biochemical progression free survival (BPFS) as defined by the Phoenix criteria (nadir PSA +2 ng/ml). Secondary outcomes of continence (defined as strictly no leak) and potency (able to have intercourse) were patient-reported. Factors influencing BPFS were evaluated individually using Kaplan Meier and in a multivariate model using Cox regression.
Altogether, 300 men were included for analysis. The median follow-up was 18. 2 months (mean 28. 4) and median BPFS was 69. 8 months. Based on Kaplan-Meier analysis, the estimated 2 and 5 year BPFS rate was 77. 2% and 59. 1% respectively. Neo-adjuvant hormonal therapy was administered to 41% of men and this tended to occur in men with larger prostates, likely as a technical consideration for downsizing prior to cryosurgery. At multivariate analysis, the presence of Gleason score 9 or 10 (HR 1. 9) and a post-treatment PSA nadir of ≥ 0. 4 ng/ml (HR 5. 7) were the only significant variables associated with biochemical progression using Cox regression. Complete continence was noted in 90. 5% of men and potency in 17% of men at 12-month follow-up. The incidence of recto-urethral fistulae and urinary retention requiring intervention beyond temporary catheterization was 1. 3% and 3. 3% respectively.
Primary cryotherapy appears to be effective and safe in the community setting for high-grade, clinically localized prostate cancer in the short term.
Journal of endourology / Endourological Society. 2015 Sep 28 [Epub ahead of print]
Kae Jack Tay, Thomas J Polascik, Ahmad Elshafei, Michael L Cher, Robert Given, Vladimir Mouraviev, Ashley Ross, J Stephen Jones
Duke University Medical Center, Urologic Surgery, Durham, North Carolina, United States. Duke University Medical Center, Urologic Surgery , Box 3707 , Durham, North Carolina, United States , 27710 , 919-684-5057 , 919-684-8794 ; cleveland clinic, urology , 9500 euclid avenue , cleveland, Ohio, United States , 44195. , Wayne State University School of Medicine, Karmanos Cancer Center, Detroit, Michigan, United States ; Eastern virginia Medical School, Urology , 225 Clearfield Ave , Norfolk, Virginia, United States , 23462 , 757 457-5177 ; Orlando, Florida, United States ; Brady Urological Institute, Johns Hopkins Medical Institutions , 600 North Wolfe Street , Baltimore, Maryland, United States , 21287 ; The Cleveland Clinic, Glickman Urological & Kidney Institute, Cleveland, Ohio, United States