Kae Jack Tay1, Thomas J Polascik1, Ahmed Elshafei2,3, Michael L Cher4, Robert W Given5, Vladimir Mouraviev6, Ashley E Ross7, J Stephen Jones2. 1. 1 Division of Urology, Duke University , Durham, North Carolina. 2. 2 Glickman Institute of Urology , Cleveland Clinic, Cleveland, Ohio. 3. 3 Urology Department, Al Kasr Al Aini Hospital, Cairo University , Giza, Egypt . 4. 4 Karmanos Cancer Center, Wayne State University School of Medicine , Detroit, Michigan. 5. 5 Department of Urology, East Virginia Medical School , Norfolk, Virginia. 6. 6 Florida Hospital, Orlando, Florida. 7. 7 Department of Urology, Oncology and Pathology, Johns Hopkins School of Medicine , Baltimore, Maryland.
Abstract
OBJECTIVE: To evaluate the oncological and functional outcomes of primary cryotherapy in men with clinically localized, high-grade prostate cancer. SUBJECTS AND METHODS: We included all men with biopsy Gleason score ≥8, localized (cT1-2) disease with a serum prostate-specific antigen (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. RESULTS: 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. Neoadjuvant 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 before cryosurgery. At multivariate analysis, the presence of Gleason score 9 or 10 (Hazard Ratio [HR] 1.9) and a posttreatment 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 the 12-month follow-up. The incidence of rectourethral fistulae and urinary retention requiring intervention beyond temporary catheterization was 1.3% and 3.3%, respectively. CONCLUSION: Primary cryotherapy appears to be effective and safe in the community setting for high-grade, clinically localized prostate cancer in the short term.
OBJECTIVE: To evaluate the oncological and functional outcomes of primary cryotherapy in men with clinically localized, high-grade prostate cancer. SUBJECTS AND METHODS: We included all men with biopsy Gleason score ≥8, localized (cT1-2) disease with a serum prostate-specific antigen (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. RESULTS: 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. Neoadjuvant 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 before cryosurgery. At multivariate analysis, the presence of Gleason score 9 or 10 (Hazard Ratio [HR] 1.9) and a posttreatment 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 the 12-month follow-up. The incidence of rectourethral fistulae and urinary retention requiring intervention beyond temporary catheterization was 1.3% and 3.3%, respectively. CONCLUSION: Primary cryotherapy appears to be effective and safe in the community setting for high-grade, clinically localized prostate cancer in the short term.
Authors: Nima Nassiri; Edward Chang; Patricia Lieu; Alan M Priester; Daniel J A Margolis; Jiaoti Huang; Robert E Reiter; Frederick J Dorey; Leonard S Marks; Shyam Natarajan Journal: J Urol Date: 2017-08-19 Impact factor: 7.600
Authors: Tarek Taha; Wei Phin Tan; Ahmed Elshafei; Alireza Aminsharifi; Robert Given; Michael L Cher; Thomas J Polascik Journal: Curr Urol Date: 2021-05-04