Cryo On-Line Data Registry Research Articles

Intermediate-term oncological and functional outcomes of salvage cryotherapy for the management of prostate cancer recurrence after primary brachytherapy versus primary cryotherapy: A propensityscore-matched analysis.

Salvage cryotherapy (SCT) is widely used to treat prostate cancer (PCa) recurrence after radiotherapy (RT). We studied the intermediate oncological and functional outcomes of patients who underwent SCT following cryotherapy (CRYO-SCT) recurrence and compare it to recurrence after brachytherapy (BT-SCT). An IRB-approved retrospective cohort study utilizing patient data from the Cryo On-Line DataRegistry and the Duke PCa database between 1992 and 2016. Biochemical recurrence (BCR) using Phoenix criteria was the primary endpoint assessed at 2- and 5-years post-SCT. Secondary endpoints assessed functional outcomes including urinary continence, erectile function, and recto-urethral fistula. Association between treatment and biochemical progression-free survival was assessed using inverse probability weighted (IPTW) Cox proportional hazards regression. The differences in the secondary functional outcomes were assessed by Pearson's χ2 test or Fisher's exact test, corrected for IPTW. A total of 194 patients met inclusion criteria. The BCR rate for BT-SCT and CRYO-SCT was 23 (20.4%) and 17 (21%) at 2 years and 30 (26.5%) and 22 (27.2%) at 5 years according to Phoenix criteria. There was no statistical difference in 2 years(hazard ratio [HR] 0.9; 95% confidence interval [CI], 0.5-1.7, p = 0.7) or 5-year BCR (HR: 0.86; 95% CI, 0.5-1.5, p = 0.6) between the groups. The functional outcomes like urinary continence (p = 0.4), erectile function (p = 0.1), and recto-urethral fistula (p = 0.3) were not statistically different. CRYO-SCT appears to be well tolerated, with comparable oncological and functional outcomes to patients failing primary BT. The findings also demonstrated that SCT can render a significant number of patients biochemically free of disease after initial CRYO with minimal morbidity. SCT is a viable treatment option to salvage local PCa recurrence following either BT or cryoablation failure.

Does the type of cryoprobe affect oncological and functional outcomes in men with clinically localized prostate cancer treated with primary whole gland prostate cryoablation?

Background:This study aimed to compare the oncological and functional outcomes of primary whole gland cryoablation of the prostate using the variable ice cryoprobe (V-Probe®) and the conventional fixed-size ice probe.Materials and methods:We reviewed the Cryo On-Line Data Registry for men who were treated with primary whole gland prostate cryoablation from 2000 through 2017. A multivariate Cox proportional hazards model was used to compare timing to biochemical recurrence between the V-Probe® and fixed-size ice probe after adjusting for preoperative prostate-specific antigen (PSA), neoadjuvant androgen deprivation therapy, preoperative Gleason score, and preoperative T stage.Results:A total of 1124 men were included. Median age, Gleason score, and pretreatment PSA were 70 years (interquartile range [IQR]: 65–74 years), 7 (IQR: 6–7) and 5.9 ng/mL (IQR: 4.6–8.1 ng/mL), respectively. The median follow-up time was 25.0 months (IQR: 11.2–48.6 months). V-Probes® were used in 269 (23.9%) cases and fixed-size ice probes in 858 (76.1%) cases. After adjusting for clinical T stage, PSA, neoadjuvant androgen deprivation therapy and preoperative Gleason score, on the multivariate Cox regression model, we found that there was no significant difference between the type of probe and timing to biochemical recurrence (p = 0.35). On multivariate logistic regression, using the V-Probe® was associated with a 91% increase in postoperative urinary retention compared to the fixed-size ice probe (p = 0.003).Conclusions:The use of the V-Probe® versus conventional fixed-size ice probe was not associated with a difference in biochemical recurrence in patients undergoing primary cryoablation of the prostate.

Predictors of Rectourethral Fistula Formation After Primary Whole-Gland Cryoablation for Prostate Cancer: Results from the Cryo On-Line Database Registry.

To define the incidence and risk factors associated with rectourethral fistula (RUF) formation following primary whole-gland cryosurgery using a multicenter centralized registry. The Cryo On-Line Data (COLD) registry was queried for men undergoing primary whole-gland cryotherapy between 1990 and 2014 who developed a RUF. Patient factors and disease parameters were correlated with RUF using chi-square and the t-test. Variables with p < 0.25 were entered into a binary logistic regression with stepwise backward elimination to determine the factors associated with RUF formation. A total of 4102 men underwent primary whole-gland cryotherapy in the COLD registry at the time of analysis. Postoperative RUF was documented in 50 out of 4102 cases (1.2%). Patients with RUF had similar demographic data, prostate volume, preoperative prostate-specific antigen level, and clinical stage in comparison to those without fistula. On both univariate and multivariate analyses, postoperative urinary retention (odds ratio [OR]: 6.30; confidence interval [95% CI] 3.43-11.58, p < 0.001), preoperative Gleason score of ≥7 (OR: 1.92; 95% CI 1.08-3.43, p = 0.027), and preoperative incontinence (OR: 2.95; 95% CI 1.12-7.76, p = 0.028) were the most significant risk factors associated with RUF formation. Primary whole-gland cryotherapy for prostate cancer is associated with a historically low rate (1.2%) of postoperative RUF formation. The rate decreased further to 0.55% over the last several years, suggesting better patient selection and technical improvement. Postoperative urinary retention, Gleason score ≥7, and preoperative urinary incontinence were the key demographic, clinical, and pathologic features associated with RUF formation in this study.

Propensity Score-Matched Comparison of Partial to Whole-Gland Cryotherapy for Intermediate-Risk Prostate Cancer: An Analysis of the Cryo On-Line Data Registry Data.

To compare the oncologic and functional outcomes of partial vs whole-gland cryotherapy for men with intermediate-risk prostate cancer. Men with intermediate-risk prostate cancer treated with primary prostate cryotherapy from 1993 to 2013 were selected from the Cryo On-Line Data Registry for a 1:1 matched comparison between those undergoing whole-gland and partial prostate cryotherapy (targeted ablation, unilateral/bilateral nerve-sparing ablations). A propensity score was developed based on age, prebiopsy serum prostate-specific antigen, biopsy Gleason score, clinical stage, prostate volume, neoadjuvant androgen deprivation status, year of surgery, and pretreatment potency. Outcomes were biochemical progression-free survival (BPFS) using the American Society for Therapeutic Radiation Oncology (ASTRO) and Phoenix criteria, 12-month continence (strictly pad free), and sexual function (potency sufficient for sexual intercourse). After propensity score matching, BPFS was compared using Kaplan-Meier analysis and functional outcomes using chi-square tests. In all, 897 men were identified (731 whole gland and 166 partial). Postmatching, 166 pairs of men were analyzed (mean follow-up 31 months). The 2/5-year BPFS rate was 87.2%/76.4% for whole-gland vs 80.7%/70.0% for partial ablation using Phoenix (p = 0.26) and 72.3%/69.6% for whole-gland vs 82.1%/75.0% for partial ablation using ASTRO criteria (p = 0.10). Of 164 pairs, the 12-month continence rate was similar, 94.1% vs 95.1% (p = 0.803). Of 139 pairs, the 12-month rate of effective intercourse was 29.5% for whole-gland and 46.8% for partial ablation (odds ratio 2.1, p = 0.003). The incidence of post-treatment urinary retention was 6.0% and 6.6% (p = 0.88) following whole-gland and partial ablation, respectively, and that of rectourethral fistula was 1.2% and 0% (p = 0.50). Partial ablation results in better post-treatment sexual function compared with whole-gland ablation in men with intermediate-risk prostate cancer. We did not observe a difference in early BPFS between the two groups.

MP18-16 PROPENSITY SCORE MATCHED COMPARISON OF PARTIAL TO WHOLE GLAND CRYOTHERAPY FOR INTERMEDIATE-RISK PROSTATE CANCER: AN ANALYSIS OF THE COLD REGISTRY DATA

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy1 Apr 2016MP18-16 PROPENSITY SCORE MATCHED COMPARISON OF PARTIAL TO WHOLE GLAND CRYOTHERAPY FOR INTERMEDIATE-RISK PROSTATE CANCER: AN ANALYSIS OF THE COLD REGISTRY DATA Kae Jack Tay, Thomas Polascik, Ahmed Elshafei, Efrat Tsivian, and J. Stephen Jones Kae Jack TayKae Jack Tay More articles by this author , Thomas PolascikThomas Polascik More articles by this author , Ahmed ElshafeiAhmed Elshafei More articles by this author , Efrat TsivianEfrat Tsivian More articles by this author , and J. Stephen JonesJ. Stephen Jones More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2717AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Patients with intermediate-risk prostate cancer constitute a unique group of patients in whom cure may be both necessary and possible. While there has been increasing interest in partial gland therapies to reduce the morbidity of treatment, randomized comparisons to whole gland therapies have been lacking. We aim to compare the oncological and functional outcomes of partial versus whole gland cryotherapy for intermediate-risk prostate cancer. METHODS Men with D'Amico intermediate-risk prostate cancer treated with primary prostate cryotherapy were selected from the Cryo On-Line Data Registry. Men treated with partial prostate ablation (targeted ablation, unilateral/ bilateral nerve-sparing ablations) were matched 1:1 to controls who had undergone whole gland cryotherapy using a propensity score approach. The propensity score was based on age, pre-biopsy serum prostate specific antigen level, biopsy Gleason score, clinical stage, prostate volume, use of neoadjuvant androgen deprivation and year of surgery. The outcomes analysed were biochemical progression free survival (BPFS) using the ASTRO and Phoenix criteria, the 12 month continence rate (defined as being pad-free) and sexual function at 12 months (defined as the ability to have sexual intercourse. RESULTS A total of 1,749 men were identified, of whom 1,488 had undergone whole gland and 288 partial prostate cryotherapy. 200 pairs of men with complete outcome data at a mean follow-up of 30 months were analysed. The 2 and 5 year BPFS rate was 71.6% and 63.5% for whole gland vs. 81.0% and 74.6% for partial prostate ablation using the ASTRO criteria (p=0.0275) and 89.6% and 79.1% for whole gland vs. 79.8% and 68.5% for partial prostate ablation using the Phoenix criteria (p=0.0588). Of 198 pairs of men, the 12- month continence rate was identical at 95%. Of 154 pairs of men, the 12-month rate of successful intercourse was 26.6% for whole gland and 45.5% for partial prostate ablation (p=0.001). The rate of rectal fistula was 0.37% in the partial ablation group. CONCLUSIONS Biochemical progression free survival after partial prostate ablation is not significantly inferior to whole gland cryotherapy in the short to medium term and may result in better sexual function at 12 months. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e199 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Kae Jack Tay More articles by this author Thomas Polascik More articles by this author Ahmed Elshafei More articles by this author Efrat Tsivian More articles by this author J. Stephen Jones More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

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

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 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. 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. Primary cryotherapy appears to be effective and safe in the community setting for high-grade, clinically localized prostate cancer in the short term.

Salvage focal prostate cryoablation for locally recurrent prostate cancer after radiotherapy: Initial results from the cryo on-line data registry

Several investigators have tried to apply salvage focal prostate cryoablation to small numbers of patients with biopsy-proven unilateral recurrent prostate cancer (PCa) after radiotherapy with the aim of decreasing complications of salvage cryoablation. We report contemporary outcomes of salvage focal cryoablation for locally recurrent PCa after radiotherapy within the Cryo On-Line Data (COLD) Registry. We queried the COLD Registry to identify patients diagnosed as locally recurrent PCa after radiotherapy and treated with salvage focal cryoablation. Patients with hormone ablation after cryotherapy were excluded. The biochemical disease-free survival and morbidities were analyzed. Biochemical failure was defined using the Phoenix definition. From 2002 to 2012, 91 patients with biopsy-proven radio-recurrent PCa underwent salvage focal cryoablation with curative intent. The biochemical disease-free survival rates were 95.3%, 72.4%, and 46.5% at 1, 3, and 5 years, respectively. Positive biopsies after salvage focal cryoablation were observed in four of 14 patients who underwent biopsy (28.6%). Rectourethral fistula was observed in three cases (3.3%). Urinary retention was observed in six cases (6.6%). Incontinence (requiring pad use) was reported in five cases (5.5%). Intercourse was reported in 10 of 20 patients (50%) who reported potency before salvage focal cryoablation. The outcomes from this observational study indicate that salvage focal cryoablation can be an effective treatment with encouraging potency preservation for patients with locally recurrent PCa after radiotherapy. However, other morbidity including rectourethral fistula and incontinence are not clearly lower than for patients treated with salvage whole gland cryoablation. Studies with longer follow-up, more patients, and direct comparison to salvage whole gland cryoablation are needed before recommending salvage focal cryoablation as a standard treatment option for these patients.

MP45-16 CRYO ONLINE DATA REGISTRY OUTCOMES: MINIMUM FIVE YEAR FOLLOW UP DATA

You have accessJournal of UrologyProstate Cancer: Localized III1 Apr 2014MP45-16 CRYO ONLINE DATA REGISTRY OUTCOMES: MINIMUM FIVE YEAR FOLLOW UP DATA David Levy, Christopher Williams, Thomas Polascik, and Stephen Jones David LevyDavid Levy More articles by this author , Christopher WilliamsChristopher Williams More articles by this author , Thomas PolascikThomas Polascik More articles by this author , and Stephen JonesStephen Jones More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1213AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction and Objectives We report a comprehensive update of 5 year COLD Registry outcomes for patients undergoing primary whole gland prostate cryoablation. Methods A risk stratified cohort of 1,111 treatment naïve patients who underwent primary whole gland cryoablation was identified. 5 year biochemical progression free Kaplan Meier survival curves were constructed based on Phoenix definition. Results Overall bPFS was: 79.9%, 64.1% and 68.1%, low, intermediate and high risk, respectively, (Figure 1). For 817 (73.5%) patients with nadir PSA < 0.4 ng/ml, bPFS was 91%, 80.5%, and 77.6%, low, intermediate and high risk, respectively. Patients with a nadir PSA > 0.4 ng/ml demonstrated 24-month biochemical progression rates in excess of 34%. Continence was preserved in 93.4% of patients, while 5.9% of patients had retention and 0.5% developed a rectal fistula. Potency data entered into the Registry data base revealed that 35% of patients were potent at 12 months. Conclusions 5 year bPFS following prostate cryoablation is comparable to surgical and radiation outcomes across all risk categories with a lower likelihood of procedure related complications. A nadir PSA > 0.4 ng/ml predicts a high likelihood of biochemical progression and warrants close follow up. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e465 Peer Review Report Advertisement Copyright & Permissions© 2014MetricsAuthor Information David Levy More articles by this author Christopher Williams More articles by this author Thomas Polascik More articles by this author Stephen Jones More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Outcomes of salvage prostate cryotherapy stratified by pre-treatment PSA: update from the COLD registry

In this study, we evaluate the outcomes of salvage cryotherapy for locally recurrent prostate cancer within the COLD (cryo online data) Registry. Furthermore, we assess the results of salvage cryotherapy (with intermediate follow-up) stratified by pre-treatment prostate-specific antigen (PSA) levels to determine which patients may best be suited for treatment. The COLD registry was developed as a prospective, centrally collected database among patients undergoing salvage cryoablation for locally recurrent prostate cancer following primary prostate radiotherapy with curative intent. Of the patients undergoing salvage cryotherapy (without neoadjuvant hormonal ablative therapy), complete medical records were available in 156 patients, with their mean follow-up being 3.8 years (0.9-12.7 years). The treatment outcomes of salvage cryotherapy were assessed using the Phoenix definition (nadir PSA + 2 ng/ml) of biochemical failure. Of our entire study population, the biochemical disease-free survival (bDFS) rates at 1, 2, and 3 years were 89.0, 73.7, and 66.7%, respectively. Stratification of our patients into two subgroups is based on their pre-treatment total serum PSA values <5 and ≥5 ng/ml, and bDFS rates at 3 years for these two subgroups were 78.3 and 52.9%, respectively. A Kaplan-Meier analysis of bDFS stratified by these same pre-treatment PSA values revealed that the subset of patients with a PSA ≥ 5 ng/ml had statistically significant poorer bDFS rates (P = 0.01). Salvage prostate cryotherapy is a potentially curative local salvage therapy. The importance of early referral when patients have a pre-treatment PSA < 5 ng/ml is essential to optimize treatment outcomes.

Achieving the ‘bifecta’ using salvage cryotherapy for locally recurrent prostate cancer: analysis of the Cryo On‐Line Data (COLD) Registry data

Study Type - Outcomes (cohort). Level of Evidence 2b. What's known on the subject? and What does the study add? The cancer-specific outcomes of salvage cryotherapy for locally recurrent prostate cancer have been well established within contemporary scientific literature. However, very little is known about the outcomes of salvage cryotherapy encompassing health-related quality of life considerations such as continence after treatment. We think the present study is quite novel, as it proposes a new therapeutic endpoint to evaluate the efficacy and outcomes of salvage therapies for locally recurrent prostate cancer, which we have termed the 'bifecta'. In addition, we report that in a large multicentre data registry, such as the COLD Registry, the therapeutic 'bifecta' can be achieved in most patients. • To evaluate the contemporary outcomes of salvage cryotherapy for locally recurrent prostate cancer using the Cryo On-Line Data (COLD) Registry. • We also evaluate the outcomes of salvage cryotherapy in achieving the therapeutic 'bifecta' consisting of: (i) achieving a post-cryotherapy nadir serum PSA level of <0.6 ng/mL and (ii) no urinary incontinence. • A prospectively, centrally collected secure online database has been developed of patients undergoing salvage cryoablation for locally recurrent prostate cancer. Of the patients undergoing salvage cryotherapy (in the absence of neoadjuvant hormonal ablative therapy) included within the COLD Registry, complete medical records pertaining to continence status and serial PSA measurements after treatment were available in 183 patients. • The therapeutic 'bifecta' was achieved in 133 of these patients (72.7%). • Of the patients achieving the 'bifecta', the mean (sd) age at presentation was 71.5 (6.6) years. • Most patients (91%) had a baseline pre-salvage total serum PSA level of <10 ng/mL and a pre-treatment biopsy Gleason score of <8 (85%). • The mean duration of follow-up of patients achieving the 'bifecta' was 36.5 months. • The therapeutic 'bifecta', a new surrogate benchmark for salvage therapies, can be achieved in most patients undergoing salvage cryotherapy. • Therefore, salvage cryotherapy is a reasonable treatment choice for locally recurrent prostate cancer in appropriately selected patients.

Primary full‐gland prostate cryoablation in older men (&gt; age of 75 years): results from 860 patients tracked with the COLD Registry

Study Type - Therapy (outcomes research). 2c. What's known on the subject? and What does the study add? Most elderly patient with prostate cancer undergo radiation therapy, but cryoablation has gained popularity. This study demonstrates the safety and efficiency of this new approach. • To report on the largest data set regarding outcomes for whole gland prostate cryoablation as a primary treatment of prostate cancer in older men, which we empirically defined as age >75 years. • The COLD (Cryo On-Line Data) Registry consists of case report forms with pre- and post-treatment information obtained from patients undergoing prostate cryoablation. • A total of 860 patients were stratified into low-, intermediate- and high-risk groups (D'Amico 2003 risk definitions). • Biochemical disease-free survival (bDFS) was defined according to the traditional American Society for Therapeutic Radiology and Oncology definition (3 increases) and the newer (Phoenix) definition (nadir +2). • Biopsy was performed at physician discretion but most commonly for cause if a patient had an increasing or suspicious prostate-specific antigen level (PSA). • The median age was 79 years (76-91) and the median follow-up was 16 months (4-60). • The 5-year [95% confidence interval (CI)] bDFS for the entire population using ASTRO and Phoenix definitions was 79% (4%) and 62.6% (8.3%), respectively. • Stratified by risk group, 5-year bDFS (ASTRO) was 82.4% (7.9%), 78.3% (5.8%) and 77.6% (7.7%) for low, moderate and high risk, respectively. • Using the Phoenix definition, 5-year bDFS was 74.9%± 15.3%, 61.4%± 13.2% and 58.0%± 11.9% for low-, moderate- and high-risk groups, respectively. • Incontinence was reported in eight patients (0.9%). • Whole gland cryoablation in older men maintains oncological efficacy similar to that of younger men without increased morbidity.

1466 ACHIEVING THE “TRIFECTA” WITH PRIMARY CRYOTHERAPY FOR LOCALIZED PROSTATE CANCER: COLD REGISTRY DATA

You have accessJournal of UrologyProstate Cancer: Localized1 Apr 20111466 ACHIEVING THE “TRIFECTA” WITH PRIMARY CRYOTHERAPY FOR LOCALIZED PROSTATE CANCER: COLD REGISTRY DATA Philippe E Spiess, Robert Given, and J Stephen Jones Philippe E SpiessPhilippe E Spiess Tampa, FL More articles by this author , Robert GivenRobert Given Norfolk, VA More articles by this author , and J Stephen JonesJ Stephen Jones Cleveland, OH More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1401AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES In the present study, we evaluate the contemporary outcome of primary cryotherapy (with curative intent) for localized prostate cancer using the COLD (Cryo On-Line Data) Registry. Furthermore, we evaluate the therapeutic outcomes of primary cryotherapy in achieving the “trifecta” post-treatment defined as: ((1) achieving a nadir serum PSA < 0.6 ng/ml, (2) no urinary incontinence, and (3) ability to have sexual intercourse (with or without intervention). METHODS A prospectively, centrally collected secure online database has been developed of patients undergoing primary cryoablation for localized prostate cancer. Of the 4,321 patients undergoing primary cryotherapy included within the COLD Registry, complete medical records pertaining to continence status and serial PSA measurements post-treatment were available in 739 patients, with the therapeutic “trifecta” achieved in 364 of 739 patients (49.2%). RESULTS The mean age of patients at presentation was 66.9 years (+/− 7.6 years). The majority of patients had a baseline PSA < 10 ng/ml, a biopsy Gleason score < 8, and clinical stage < T2b (82%, 92%, and 66%; respectively). Most patients stratified in the low and intermediate (D'Amico) risk categories (25% and 49%, respectively). The 1, 2, and 5 year actuarial biochemical failure rates using the Phoenix definition (nadir + 2 ng/ml) were 94.1%, 91.2%, and 78.5%, respectively. At year following primary cryotherapy, urinary retention developed in 0.3% and urinary fistulas in 0.3% of patients. CONCLUSIONS The “trifecta” was achieved in close to half of the patients undergoing primary cryotherapy highlighting its therapeutic potential in the management of localized prostate cancer clearly however a prospective, long-term study is needed to validate these findings. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e587-e588 Peer Review Report Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Philippe E Spiess Tampa, FL More articles by this author Robert Given Norfolk, VA More articles by this author J Stephen Jones Cleveland, OH More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

1639 ACHIEVING THE “TRIFECTA” USING FOCAL CRYOTHERAPY AS A PRIMARY TREATMENT FOR PROSTATE CANCER: COLD REGISTRY DATA

You have accessJournal of UrologyProstate Cancer: Localized1 Apr 20111639 ACHIEVING THE “TRIFECTA” USING FOCAL CRYOTHERAPY AS A PRIMARY TREATMENT FOR PROSTATE CANCER: COLD REGISTRY DATA Philippe E. Spiess, Robert Given, Vladimir Mouraviev, and J. Stephen Jones Philippe E. SpiessPhilippe E. Spiess Tampa, FL More articles by this author , Robert GivenRobert Given Norfolk, VA More articles by this author , Vladimir MouravievVladimir Mouraviev Cincinnati, OH More articles by this author , and J. Stephen JonesJ. Stephen Jones Cleveland, OH More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1748AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES In the present study, we evaluate the ability to achieve the therapeutic “trifecta” with focal cryotherapy using the COLD (Cryo On-Line Data) Registry. Focal cryotherapy was conducted using various templates of cryoablation. The “trifecta” being defined as (post-treatment): (1) achieving a nadir serum PSA < 0.6 ng/ml based on publication suggesting this surrogate, (2) no urinary incontinence, and (3) ability to have sexual intercourse (with or without intervention). METHODS A prospectively, centrally collected secure online database has been developed of patients undergoing focal cryoablation (using various partial gland templates) for localized prostate cancer. Of the 1214 patients undergoing focal cryotherapy which are included within the COLD Registry, complete medical records pertaining to continence status, ability to maintain sexual activity, and serial PSA measurements post-treatment were available in 308 patients, with the therapeutic “trifecta” achieved in 156 of these patients (51%). RESULTS Of the patient achieving the “trifecta”, the mean age at presentation was 65.9 years (+/− 8.0 years). The majority of patients had a baseline PSA < 10 ng/m, a clinical stage < T2b, and a biopsy Gleason score < 8 (85%, 84%, and 95%; respectively). The 1, 2, and 5 year actuarial biochemical failure rates using the Phoenix definition (nadir + 2 ng/ml) were 96.2%, 95.0%, and 93.2%, respectively. Following focal cryotherapy, urinary retention occurred in 3 (1.9%) and urethral fistulas in 1 (0.6%) of patients. CONCLUSIONS Focal cryotherapy has been evaluated as a potential treatment choice for well selected patients in an attempt to minimize morbidity without compromising oncological outcome in patients with low volume disease. The present study highlights that only 51% of patients achieved the therapeutic “trifecta” raising into question its true benefit over established treatment choices for localized prostate cancer. We do acknowledge however that the templates of focal cryoablation varied significantly within this cohort of patients. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e658 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Philippe E. Spiess Tampa, FL More articles by this author Robert Given Norfolk, VA More articles by this author Vladimir Mouraviev Cincinnati, OH More articles by this author J. Stephen Jones Cleveland, OH More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Primary Cryoablation Nadir Prostate Specific Antigen and Biochemical Failure

We correlated nadir post-cryoablation prostate specific antigen with long-term biochemical disease-free survival in a risk stratified cohort of patients with prostate cancer treated with cryoablation. The records of 2,427 patients treated with cryoablation from the Cryo On-Line Data Registry were studied for biochemical disease-free survival based on nadir + 2 criteria using prostate specific antigen determinations out to 60 months after cryoablation. For nadir prostate specific antigen less than 0.1 ng/ml, the 36, 48 and 60-month biochemical disease-free survival was 93%, 91.8% and 91.8%, respectively, for low risk disease; 88%, 81% and 76%, respectively, for intermediate risk; and 82%, 76% and 71%, respectively, for high risk disease. For prostate specific antigen 0.1 to 0.5 ng/ml the 36, 48 and 60-month biochemical disease-free survival rates were 92%, 91.5% and 86%, respectively, for low risk; 78%, 72% and 67%, respectively, for intermediate risk; and 64%, 61% and 51%, respectively, for high risk disease. For a prostate specific antigen of 0.6 to 1.0 ng/ml the 24-month biochemical disease-free survival was 70.5% for low risk, 56.1% for intermediate risk and 46.7% for high risk disease. A prostate specific antigen of 1.1 to 2.5 ng/ml was associated with a 12-month failure rate of 29.6%, 38% and 74.8% for low, intermediate and high risk groups, respectively. Nadir prostate specific antigen after prostate cryoablation is prognostic for biochemical disease-free survival. However, by itself it cannot be used as a definition of disease-free survival since it has not been correlated with disease specific or metastasis-free survival. A prostate specific antigen of 0.6 ng/ml or greater correlated with a 29.5% biochemical failure rate at 24 months regardless of risk stratification and, therefore, these cases require close followup.

Salvage Prostate Cryoablation: Initial Results From the Cryo On-Line Data Registry

We report contemporary outcomes of salvage cryoablation at a large number of centers which have participated in the COLD (Cryo On-Line Data) Registry. A secure online database was developed to collect data for patients undergoing prostate cryoablation. Kaplan-Meier analysis was performed with biochemical failure defined using the American Society of Therapeutic Radiology and Oncology, and the Phoenix definitions. Data from 279 patients who had undergone salvage cryoablation were entered. Average patient age was 70.0 +/- 7.1 years. Pretreatment prostate specific antigen was 7.6 +/- 8.2 ng/ml and Gleason score was 7.5 +/- 1.1 (median 7). Patients were followed for 21.6 +/- 24.9 months and 47 were followed longer than 5 years. The 5-year actuarial biochemical disease-free rates were 58.9% +/- 5.7% (American Society of Therapeutic Radiology and Oncology) and 54.5% +/- 4.9% (Phoenix). As predicted based on the preservation of some prostatic tissue, 83% +/- 3.5% of patients had a detectable prostate specific antigen 0.2 ng/ml or greater at 5 years. Positive biopsies were observed in 15 of the 46 patients (32.6%) who underwent prostate biopsy after salvage cryotherapy. The incontinence rate (requiring pad use) was 4.4%. The rectal fistula rate was 1.2% and 3.2% of patients underwent transurethral prostate resection to remove sloughed tissue. Biochemical and local control rates support the use of salvage cryoablation for localized recurrence following failed radiation therapy. Efforts to continue to minimize these complications and to improve disease control in patients with persistent cancer following definitive radiotherapy should continue.

Whole Gland Primary Prostate Cryoablation: Initial Results From the Cryo On-Line Data Registry

We report the largest data set to date to our knowledge regarding outcomes for primary whole gland prostate cryoablation. The COLD (Cryo On-Line Data) Registry consists of case report forms obtaining pretreatment and posttreatment information for patients undergoing whole gland prostate cryoablation. A total of 1,198 patients were stratified into low, intermediate and high risk groups. Biochemical success was defined according to the traditional American Society for Therapeutic Radiology and Oncology definition (3 increases) and the newer (Phoenix) definition (nadir +2). Biopsy was performed at physician discretion but most commonly for cause if a patient had an increasing or suspicious prostate specific antigen. Average patient age was 69.8 +/- 7.5 years. Pretreatment prostate specific antigen was 9.6 +/- 8.6 ng/ml and median Gleason sum was 7 (range 4 to 10). Patients were followed for 24.4 +/- 25.9 months with 136 having minimum 5-year data. The 5-year biochemical disease-free status for the entire population was 77.1% +/- 2.1% (American Society for Therapeutic Radiology and Oncology) and 72.9% +/- 2.1% (Phoenix). Five-year American Society for Therapeutic Radiology and Oncology biochemical disease-free status was 84.7% +/- 4.5%, 73.4% +/- 4.3% and 75.3% +/- 3.7% for the low, moderate and high risk groups, respectively. Using the Phoenix definition the biochemical disease-free status was 91.1% +/- 2.9%, 78.5% +/- 3.6% and 62.2% +/- 4.9%, respectively. As predicted based on intentional preservation of some prostatic tissue, 72.5 +/- 1.8% had a detectable prostate specific antigen 0.2 ng/ml or greater at 5 years. Biopsy after cryotherapy was positive during empiric without cause biopsy in 30 of 207 patients (14.5%), and the highly selected group biopsied based on suspicion of treatment failure due to abnormal or increasing prostate specific antigen had positive results in 38.0% (49 of 129). The rectal fistula rate was 0.4% and incontinence was 4.8% with 2.9% of patients using pads. Intercourse was reported by 25.2% but only 8.8% without pharmaceutical or device assistance. Whole gland cryoablation, practiced in a spectrum of academic and community users, maintains efficacy and morbidity similar to that of single center reports.

MP-18.23: Primary cryoablation for Gleason 8, 9 or 10 localized prostate cancer: results from the COLD registry

The use of cryoablation as an initial treatment for localized prostate cancer has increased. It is often utilized as a treatment for patients with high Gleason scores based on the ability to freeze beyond the prostatic capsule. The objective of this study is to report the outcomes of primary cryoablation when used to treat Gleason 8, 9 or 10 localized prostate cancer at a large number of centers, both academic and community, which have participated in the Cryo On-Line Data (COLD) Registry.