Primary Cryotherapy for High-Grade Clinically Localized Prostate Cancer: Oncologic and Functional Outcomes from the COLD Registry

Kae Jack Tay, Thomas J. Polascik, Ahmed Elshafei, Michael L. Cher, Robert W. Given, Vladimir Mouraviev, Ashley E. Ross, J. Stephen Jones

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)43-48
Number of pages6
JournalJournal of Endourology
Volume30
Issue number1
DOIs
StatePublished - Jan 1 2016

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Cryotherapy
Registries
Prostatic Neoplasms
Disease-Free Survival
Prostate-Specific Antigen
Neoplasm Grading
Cryosurgery
Neoadjuvant Therapy
Urinary Retention
Kaplan-Meier Estimate
Proportional Hazards Models
Catheterization
Fistula
Prostate
Multivariate Analysis
Survival Rate
Biopsy
Incidence
Serum

ASJC Scopus subject areas

  • Urology

Cite this

Tay, K. J., Polascik, T. J., Elshafei, A., Cher, M. L., Given, R. W., Mouraviev, V., ... Jones, J. S. (2016). Primary Cryotherapy for High-Grade Clinically Localized Prostate Cancer: Oncologic and Functional Outcomes from the COLD Registry. Journal of Endourology, 30(1), 43-48. https://doi.org/10.1089/end.2015.0403

Primary Cryotherapy for High-Grade Clinically Localized Prostate Cancer : Oncologic and Functional Outcomes from the COLD Registry. / Tay, Kae Jack; Polascik, Thomas J.; Elshafei, Ahmed; Cher, Michael L.; Given, Robert W.; Mouraviev, Vladimir; Ross, Ashley E.; Jones, J. Stephen.

In: Journal of Endourology, Vol. 30, No. 1, 01.01.2016, p. 43-48.

Research output: Contribution to journalArticle

Tay, KJ, Polascik, TJ, Elshafei, A, Cher, ML, Given, RW, Mouraviev, V, Ross, AE & Jones, JS 2016, 'Primary Cryotherapy for High-Grade Clinically Localized Prostate Cancer: Oncologic and Functional Outcomes from the COLD Registry', Journal of Endourology, vol. 30, no. 1, pp. 43-48. https://doi.org/10.1089/end.2015.0403
Tay, Kae Jack ; Polascik, Thomas J. ; Elshafei, Ahmed ; Cher, Michael L. ; Given, Robert W. ; Mouraviev, Vladimir ; Ross, Ashley E. ; Jones, J. Stephen. / Primary Cryotherapy for High-Grade Clinically Localized Prostate Cancer : Oncologic and Functional Outcomes from the COLD Registry. In: Journal of Endourology. 2016 ; Vol. 30, No. 1. pp. 43-48.
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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.",
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T1 - Primary Cryotherapy for High-Grade Clinically Localized Prostate Cancer

T2 - Oncologic and Functional Outcomes from the COLD Registry

AU - Tay, Kae Jack

AU - Polascik, Thomas J.

AU - Elshafei, Ahmed

AU - Cher, Michael L.

AU - Given, Robert W.

AU - Mouraviev, Vladimir

AU - Ross, Ashley E.

AU - Jones, J. Stephen

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N2 - 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.

AB - 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.

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