Patient-reported Satisfaction and Regret Following Focal Therapy for Prostate Cancer: A Prospective Multicenter Evaluation.

Background: Several reports are available regarding the treatment decision regret of patients receiving conventional treatments for localized prostate cancer (PCa); yet data on patients undergoing focal therapy (FT) are sparse. Objective: To evaluate the treatment decision satisfaction and regret among patients who underwent FT for PCa with high-intensity focused ultrasound (HIFU) or cryoablation (CRYO). Design setting and participants: We identified consecutive patients who underwent HIFU or CRYO FT as the primary treatment for localized PCa at three US institutions. A survey with validated questionnaires, including the five-question Decision Regret Scale (DRS), International Prostate Symptom Score (IPSS), and International Index of Erectile Function (IIEF-5), was mailed to the patients. The regret score was calculated based on the five items of the DRS, and regret was defined as a DRS score of >25. Outcome measurements and statistical analysis: Multivariable logistic regression models were applied to assess the predictors of treatment decision regret. Results and limitations: Of 236 patients, 143 (61%) responded to the survey. Baseline characteristics were similar between responders and nonresponders. During a median (interquartile range) follow-up of 43 (26-68) mo, the treatment decision regret rate was 19.6%. On a multivariable analysis, higher prostate-specific antigen (PSA) at nadir after FT (odds ratio [OR] 1.48, 95% confidence interval [CI] 1.1-2, p = 0.009), presence of PCa on follow-up biopsy (OR 3.98, 95% CI 1.5-10.6, p = 0.006), higher post-FT IPSS (OR 1.18, 95% CI 1.01-1.37, p = 0.03), and newly diagnosed impotence (OR 6.67, 95% CI 1.57-27, p = 0.03) were independent predictors of treatment regret. The type of energy treatment (HIFU/CRYO) was not a predictor of regret/satisfaction. Limitations include retrospective abstraction. Conclusions: FT for localized PCa is well accepted by the patients, with a low regret rate. Higher PSA at nadir, presence of cancer on follow-up biopsy, bothersome postoperative urinary symptoms, and impotence after FT were independent predictors of treatment decision regret. Patient summary: In this report, we looked at the factors affecting satisfaction and regret in patients with prostate cancer undergoing focal therapy. We found that focal therapy is well accepted by the patients, while presence of cancer on follow-up biopsy as well as bothersome urinary symptoms and sexual dysfunction can predict treatment decision regret.

A phase I prospective, non-randomized trial of autologous dendritic cell-based cryoimmunotherapy in patients with metastatic castration-resistant prostate cancer.

Metastatic castration-resistant prostate cancer (mCRPC) is an immunologically cold disease with dismal outcomes. Cryoablation destroys cancer tissue, releases tumor-associated antigens and creates a pro-inflammatory microenvironment, while dendritic cells (DCs) activate immune responses through processing of antigens. Immunotherapy combinations could enhance the anti-tumor efficacy. This open-label, single-arm, single-center phase I trial determined the safety and tolerability of combining cryoablation and autologous immature DC, without and with checkpoint inhibitors. Immune responses and clinical outcomes were evaluated. Patients with mCRPC, confirmed metastases and intact prostate gland were included. The first participants underwent prostate cryoablation with intratumoral injection of autologous DCs in a 3 + 3 design. In the second part, patients received cryoablation, the highest acceptable DC dose, and checkpoint inhibition with either ipilimumab or pembrolizumab. Sequentially collected information on adverse events, quality of life, blood values and images were analyzed by standard descriptive statistics. Neither dose-limiting toxicities nor adverse events > grade 3 were observed in the 18 participants. Results indicate antitumor activity through altered T cell receptor repertoires, and 33% durable (> 46 weeks) clinical benefit with median 40.7 months overall survival. Post-treatment pain and fatigue were associated with circulating tumor cell (CTC) presence at inclusion, while CTC responses correlated with clinical outcomes. This trial demonstrates that cryoimmunotherapy in mCRPC is safe and well tolerated, also for the highest DC dose (2.0 × 108) combined with checkpoint inhibitors. Further studies focusing on the biologic indications of antitumor activity and immune system activation could be considered through a phase II trial focusing on treatment responses and immunologic biomarkers.

Five-alpha reductase inhibitors in men undergoing active surveillance for prostate cancer: impact on treatment and reclassification after 6 years follow-up.

OBJECTIVES: To evaluate the impact of 5-alpha reductase inhibitors (5-ARIs) on definitive treatment (DT) and pathological progression (PP) in patients on active surveillance (AS) for prostate cancer. METHODS: We identified 361 consecutive patients, from an IRB-approved database, on AS for prostate cancer with minimum 2 years follow-up. Patients were grouped into two cohorts, those using 5-ARIs (5-ARI; n = 119) or not using 5-ARIs (no 5-ARI; n = 242). Primary and secondary endpoints were treatment-free survival (TFS) and PP-free survival (PPFS), which were evaluated by Kaplan-Meier analysis. Univariate and multivariable cox regression analysis were used to identify predictors for PP and DT. A p value < 0.05 was considered statistically significant. RESULTS: Baseline characteristics and the prostate biopsy rate were similar between the two groups. Median (range) follow-up was 5.7 (2.0-17.2) years. Five-year and 10-year TFS was 92% and 59% for the 5-ARI group versus 80% and 51% for the no 5-ARI group (p = 0.005), respectively. Five-year and 10-year PPFS was 77% and 41% for the 5-ARI group versus 70% and 32% for the no 5-ARI group (p = 0.04), respectively. Independent predictors for treatment and PP were not taking 5-ARIs (p = 0.005; p = 0.02), entry PSA > 2.5 ng/mL (p = 0.03; p = 0.01) and Gleason pattern 4 on initial biopsy (p < 0.001; p < 0.001), respectively. The main limitation is the retrospective study design. CONCLUSIONS: 5-ARIs reduces reclassification and cross-over to treatment in men on active surveillance for prostate cancer. Further, taking 5-ARIs was an independent predictor for prostate cancer progression and definitive treatment.

Hemigland Cryoablation of Localized Low, Intermediate and High Risk Prostate Cancer: Oncologic and Functional Outcomes at 5 Years.

PURPOSE: We evaluated 5-year oncologic and functional outcomes of hemigland cryoablation of localized prostate cancer. MATERIALS AND METHODS: We reviewed the records of 160 consecutive men who underwent hemigland cryoablation of localized prostate cancer. Recurrent and/or residual clinically significant prostate cancer was defined as Grade Group 2 or greater on followup biopsy. A prostate specific antigen nadir plus 2 ng/ml according to the Phoenix criteria was used to define biochemical failure. Radical treatment was defined as any whole gland therapy. Treatment failure was defined as any radical and/or whole gland treatment, systemic therapy initiation, metastasis or prostate cancer specific mortality. The study primary end point was treatment failure-free survival. The secondary end points were survival free of biochemical failure, clinically significant prostate cancer and radical treatment. Followup biopsy and functional outcomes were also evaluated. Statistical analysis included the Kaplan-Meier method, and univariate and multivariable Cox and logistic regression with significance considered at p <0.05. RESULTS: Median patient age was 67 years, baseline prostate specific antigen was 6.3 ng/ml and followup was 40 months. A total of 131 patients (82%) had D'Amico intermediate (66%) or high risk (16%) prostate cancer. At 5 years the treatment failure-free survival rate was 85%, the biochemical failure-free survival rate was 62% and the survival rate free of clinically significant prostate cancer was 89%. Higher baseline prostate specific antigen independently predicted treatment failure (p <0.001), biochemical failure (p=0.048), recurrence and radical treatment (p <0.01). Grade Group 3 or greater independently predicted treatment failure (p=0.04). The metastasis-free survival rate was 100% at 5 years. Pad-free continence and potency (erections sufficient for intercourse) were retained in 97% and 73% of patients, respectively. There was no rectal fistula or mortality. CONCLUSIONS: Hemigland cryoablation of localized prostate cancer provides effective midterm oncologic outcomes with good continence and potency. Patients with higher baseline prostate specific antigen are at increased risk for biochemical failure, recurrent cancer and treatment failure.

Primary Whole-gland Cryoablation for Prostate Cancer: Biochemical Failure and Clinical Recurrence at 5.6 Years of Follow-up.

We retrospectively evaluated complications and functional and oncologic outcomes of 94 consecutive men who underwent primary whole-gland cryoablation for localized prostate cancer (PCa) from 2002 to 2012. Kaplan-Meier and multivariable Cox regression analyses were performed using a landmark starting at 6 mo of follow-up. In total, 75% patients had D'Amico intermediate- (48%) or high- (27%) risk PCa. Median follow-up was 5.6 yr. Median time to prostate-specific antigen (PSA) nadir was 3.3 mo, and 70 patients reached PSA <0.2ng/ml postcryoablation. The 90-d high-grade (Clavien Grade IIIa) complication rate was 3%, with no rectal fistulas reported. Continence and potency rates were 96% and 11%, respectively. The 5-yr biochemical failure-free survival (PSA nadir+2ng/ml) was 81% overall and 89% for low-, 78% for intermediate-, and 80% for high-risk PCa (p=0.46). The median follow-up was 5.6 and 5.1 yr for patients without biochemical failure and with biochemical failure, respectively. The 5-yr clinical recurrence-free survival was 83% overall and 94% for low-, 84% for intermediate-, and 69% for high-risk PCa (p=0.046). Failure to reach PSA nadir <0.2ng/ml within 6 mo postcryoablation was an independent predictor for biochemical failure (p=0.006) and clinical recurrence (p=0.03). The 5-yr metastases-free survival was 95%. Main limitation is retrospective evaluation. Primary whole-gland cryoablation for PCa provides acceptable medium-term oncologic outcomes and could be an alternative for radiation therapy or radical prostatectomy. PATIENT SUMMARY: Cryoablation is a safe, minimally-invasive procedure that uses cold temperatures delivered via probes through the skin to kill prostate cancer (PCa) cells. Whole-gland cryoablation may offer an alternative treatment option to surgery and radiotherapy. We found that patients had good cancer outcomes 5 yr after whole-gland cryoablation, and those with a prostate-specific antigen value ≥0.2ng/ml within 6 mo after treatment were more likely to have PCa recurrence.

Image-based monitoring of targeted biopsy-proven prostate cancer on active surveillance: 11-year experience.

PURPOSE: To report our 11-year experience of Active Surveillance (AS) program focusing on modern transrectal ultrasound (TRUS)-based monitoring of targeted biopsy-proven cancer lesion. METHODS: Consecutive patients on AS, who had targeted biopsy-proven lesion followed by at least a repeat surveillance biopsy and three times TRUS monitoring of the identical visible lesion, were included. Doppler grade of blood flow signal within the lesion was classified from grade 0 to 3. Biopsy-proven progression was defined as upgrade of Gleason score or 25% or greater increase in cancer core involvement. RESULTS: Fifty patients were included in this study. Clinical variables (median) included age (61 years), clinical stage (T1c, 42;T2, 8), PSA (4.6 ng/ml), and Gleason score (3 + 3, n = 41;3 + 4, n = 9). Of the 50 patients, 34 demonstrated pathological progression at a median follow-up of 4.4 years. In comparing between without (n = 16) and with (n = 34) pathological progression, there were significant differences in cancer core involvement at entry (p = 0.003), the major axis diameter (p = 0.001) and minor axis diameter (p = 0.001) of the visible lesion at entry, increase in the major axis diameter (p = 0.005) and minor axis diameter (p = 0.013), and upgrade of Doppler grade (p < 0.0001). In multivariate analysis for predicting pathological progression, the increase (≥25%) in diameter of biopsy-proven lesion (hazard ratio, 15.314; p = 0.023) and upgrade of Doppler grade (hazard ratio, 37.409; p = 0.019) were significant risk factors. CONCLUSIONS: Longitudinal monitoring of the TRUS-visible biopsy-proven cancer provides a new opportunity to perform per-lesion-based AS. The increase in diameter and upgrade of Doppler grade of the lesion were significant risk factors for biopsy-proven progression on AS.

Real-time transrectal ultrasonography-guided hands-free technique for focal cryoablation of the prostate.

OBJECTIVES: To describe, step-by-step, our hands-free technique for focal cryoablation of prostate cancer. MATERIALS AND METHODS: After detailed discussion of its limitations and benefits, consent was obtained to perform focal cryoablation in patients with biopsy-proven unilateral low- to intermediate-risk prostate cancer. The procedure was performed transperineally, using a hands-free technique (without an external grid template) under real-time bi-plane transrectal ultrasonography (TRUS) guidance, using an argon/helium-gas-based third generation cryoablation system. Follow-up consisted of validated questionnaires, physical examination, PSA measures, multiparametric TRUS and/or magnetic resonance imaging (MRI) and mandatory biopsy. RESULTS: The important steps for achieving safety, satisfactory oncological and functional outcomes included: patient selection, including TRUS/MRI fusion target biopsy; thermocouple and cryoprobe placement with a hands-free technique, allowing delivery in unrestricted angulations according to the prostatic contour, the course of the neurovascular bundle and the rectal wall angle; and hands-free bi-plane TRUS probe manipulation to facilitate real-time monitoring of anatomical landmarks at the ideal angle of the image plane. To achieve a lethal temperature in the known cancer area, while preserving the urinary sphincter, neurovascular bundle, urethra and rectal wall, continuous intraoperative control of the thermocouple temperatures was necessary, as were real-time TRUS monitoring of ice-ball size, control of the energy delivered and the use of a warming urethral catheter. CONCLUSION: We have described step-by-step the focal cryoablation of prostate cancer using a hands-free technique. This technique facilitates the effective delivery of cryoprobes and the intra-operative real-time quick manipulation of the TRUS probe.

Salvage focal and salvage total cryoablation for locally recurrent prostate cancer after primary radiation therapy.

OBJECTIVES: To present the oncological and functional outcomes of salvage focal (SFC) and salvage total (STC) cryoablation for recurrent prostate cancer (PCa) after failed primary radiotherapy. PATIENTS AND METHODS: From March 2003 to August 2010, 50 men with biopsy-proven unilateral (n = 25) or bilateral (n = 25) radio-recurrent PCa underwent SFC or STC, respectively. Patients were assessed after treatment by prostate-specific antigen (PSA) testing, transrectal ultrasonography, biopsy and questionnaires. Biochemical failure (BF) was defined using the Phoenix criteria (PSA nadir + 2 mg/mL). Data were prospectively collected and retrospectively analysed. RESULTS: The median pre-cryoablation PSA level and Gleason score were, respectively, 2.8 ng/mL and 7 for SFC, and 3.9 ng/mL and 7 for STC. The median follow-up was 31 and 53 months (P = 0.004) for SFC and STC, respectively. Oncological outcomes were as follows: no patient died; one patient who underwent STC developed bone metastases; eight patients who underwent SFC and three who underwent STC had BF and the 5-year BF-free survival rates were 54 and 86%, respectively. In those patients without BF, the mean PSA decreased by 86% for SFC and 90% for STC within the first year and remained stable. Functional outcomes were as follows: new onset urinary incontinence occurred in three (13%) patients in the STC group, whereas no patient in the SFC group developed incontinence (P = 0.10); Two of seven patients in the SFC group retained postoperative potency, but none of the four potent patients in the STC group recovered potency postoperatively (P = 0.48); one (4%) patient in the STC group developed a recto-urethral fistula, but none occurred in the SFC group (P = 0.48). CONCLUSIONS: SFC and STC are feasible and safe with acceptable mid-term oncological outcomes. For carefully selected patients, SFC is an option that could be associated with lower treatment-related morbidity compared with STC. Although longer follow-up and more patient numbers are needed, our initial oncological and functional outcomes of SFC and STC are encouraging.

Image visibility of cancer to enhance targeting precision and spatial mapping biopsy for focal therapy of prostate cancer.

OBJECTIVE: To assess the advantages of cancer image visibility when using multiparametric transrectal ultrasonography (TRUS) in potential candidates for focal therapy for prostate cancer. PATIENTS AND METHODS: A total of 93 potential candidates for focal cryotherapy underwent grey-scale and Doppler TRUS-guided biopsy. All real-time TRUS images were recorded, allowing subsequent reviewing for the planning of targeted focal cryotherapy, and/or follow-up targeted biopsy. The spatial mapping of TRUS-visible lesions and targeted sampling areas were individually documented in schematic anatomic drawings of the prostate. Data from the baseline imaging-targeted biopsies were compared with systematic (non-targeted) biopsies. Of the 93 patients, 73 patients with low- to intermediate-risk disease were eventually considered to be candidates for hemi-ablative focal cryosurgery, i.e. cryoablation of one lobe. RESULTS: Among the 93 patients, a total of 681 biopsy cores were available for analysis, including imaging-targeted (n = 256, 37.5%) and systematic (n = 425, 62.5%) cores. Of the 256 targeted biopsy cores, 65% (n = 167) were positive for cancer, compared with 6.2% (26/425) in systematic (non-targeted) cores (P < 0.001). A total of 88% (82/93) of the biopsy-proven cancer index lesions were TRUS-visible. When comparing TRUS-visible with image-invisible index lesions, the cancer-involved core length was 6.1 vs 1.5 mm (P < 0.001), respectively. Furthermore, the percent of core with involved cancer was 48 vs 16% (P < 0.001), and the mean Gleason score was 7.0 vs 6.2 (P < 0.001). With increasing TRUS-visible lesion size (<10, 11-15, 16-20, >20 mm), cancer-involved core length and percent of core with cancer also significantly increased (P = 0.009 and P = 0.008, respectively). CONCLUSIONS: TRUS-guided targeted biopsies significantly improved the detection and staging of higher grade and larger volume cancer, compared with image-blind (non-targeted systematic) biopsies. Image visibility enhanced the precise targeting and accurate spatial mapping of cancer to help identify more appropriate candidates for focal therapy.

Primary androgen deprivation (AD) followed by active surveillance (AS) for newly diagnosed prostate cancer (PC): A retrospective study.

BACKGROUND: Active surveillance (AS) is only recommended for Low-Risk prostate cancer (PC) with <34% biopsies positive. Studies describing the long-term outcome of men treated with androgen deprivation (AD) followed by AS are sparse. MATERIALS AND METHODS: One hundred two men were treated with 12 months of AD in a medical oncology clinic specializing in PC between 1998 and 2007 and were followed for a median of 7.25 years. The biopsy complete response rate after AD and the incidence of disease progression while on subsequent AS was assessed. Baseline age, D'Amico risk category, PSA velocity, percentage core biopsies, and prostate volume were evaluated as potential predictors of disease progression. RESULTS: D'Amico risk category for the 102 men: Low: n = 22, Intermediate: n = 30, and High: n = 50. Medians: Age 67.3, PSA 7.8, Gleason 3 + 4, >50% core biopsies positive, stage T1c. Seventy men had a clear biopsy and 31 of these had disease progression leading to additional treatment after a median of 52 months. D'Amico risk category of the 57 men with a positive biopsy after AD or disease progression on AS was: Low: n = 4 (18%), Intermediate: n = 16 (53%), and High: n = 37 (74%). No PC deaths occurred. Three men had clinical progression. In stepwise logistic regression analysis only higher D'Amico risk category and lower prostate volume predicted disease progression. CONCLUSIONS: Despite a high prevalence of ≥50% core biopsies positive at baseline, AD induces durable remissions in most men with Low-Risk and about half with Intermediate-Risk PC.

Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow-up of 3.7 years.

BACKGROUND: Evolution of cryotherapy for prostate cancer is likely to result in parenchyma-sparing modifications adjacent to the urethra and neurovascular bundle. Results of initial series of focal therapy to minimize cryosurgery-related morbidity without compromising oncologic control have been encouraging, but limited in short-term outcomes. OBJECTIVE: To retrospectively report (1) median 3.7-yr follow-up experience of primary focal cryotherapy for clinically unilateral prostate cancer with oncologic and functional outcomes, and (2) matched-pair analysis with contemporaneous patients undergoing radical prostatectomy (RP). DESIGN, SETTING, AND PARTICIPANTS: Over 8.5 yr (September 2002 to March 2011), focal cryoablation (defined as ablation of one lobe) was performed in 73 carefully selected patients with biopsy-proven, clinically unilateral, low-intermediate risk prostate cancer. All patients underwent transrectal ultrasound (TRUS) and Doppler-guided sextant and targeted biopsies at entry. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Post-therapy follow-up included measuring prostate-specific antigen (PSA) level every 3-6 mo; TRUS biopsies at 6-12 mo and yearly, as indicated; and validated symptom questionnaires. Matched-pair analysis compared oncologic outcomes of focal cryotherapy and RP (matched for age, PSA, clinical stage, and biopsy Gleason score). RESULTS AND LIMITATIONS: Complete follow-up was available in 70 patients (median follow-up: 3.7 yr; range: 1-8.5 yr). No patient died or developed metastases. Precryotherapy mean PSA was 5.9 ng/ml and Gleason score was 6 (n=30) or 7 (n=43). Postcryotherapy mean PSA was 1.6 ng/ml (70% reduction compared to precryotherapy; p<0.001). Of 48 patients undergoing postcryotherapy biopsy, 36 (75%) had negative biopsies; positive biopsy for cancer (n=12) occurred in the untreated contralateral (n=11) or treated ipsilateral lobe (n=1). Complete continence (no pads) and potency sufficient for intercourse were documented in 100% and 86% of patients, respectively. Matched-pair comparison of focal cryotherapy and RP revealed similar oncologic outcome, defined as needing salvage treatment. CONCLUSIONS: Primary focal cryoablation for low-intermediate risk unilateral cancer affords encouraging oncologic and functional outcomes over a median 3.7-yr follow-up. Close surveillance with follow-up whole-gland biopsies is mandatory.

A pretreatment nomogram predicting biochemical failure after salvage cryotherapy for locally recurrent prostate cancer.

OBJECTIVE: To gather a pooled database from six tertiary-care referral centres using salvage cryotherapy (SC) for locally recurrent prostate cancer, and develop a pretreatment nomogram allowing a prediction of the probability of biochemical failure after SC, based on pretreatment clinical variables. PATIENTS AND METHODS: We retrospectively analysed 797 men treated at six tertiary-care referral centres with SC for locally recurrent disease after primary radiotherapy with curative intent. The median duration of follow-up from the time of SC to the date of last contact was 3.4 years. The primary study endpoint was biochemical failure, defined as a serum prostate-specific antigen (PSA) level after SC of >0.5 ng/mL. RESULTS: Overall, the rate of biochemical failure was 66% with a median of 3.4 years of follow-up. A logistic regression model was used to predict biochemical failure. Covariates included serum PSA level at diagnosis, initial clinical T stage, and initial biopsy Gleason score. On the basis of these results, a pretreatment nomogram was developed which can be used to help select patients best suited for SC. Our pretreatment nomogram was internally validated using 500 bootstrap samples, with the concordance index of the model being 0.70. CONCLUSION: A pretreatment nomogram based on several diagnostic variables (serum PSA level at diagnosis, biopsy Gleason grade, and initial clinical T stage) was developed and might allow the selection of ideal candidates for SC.

Focal cryoablation of prostate: a review.

Current treatment options for men with early localized prostate cancer are either some form of radical therapy or active surveillance. Radical therapy is usually associated with significant adverse effects that might jeopardize a man's quality of life. Some observers believe that PSA screening has resulted in the over diagnosis and over treatment of prostate cancer. Many men are being diagnosed with an early stage, small volume, unifocal or unilateral prostate cancer but are reluctant to accept watchful waiting or active surveillance. Focal cryoablation is the less than complete ablation of the gland with ice. Based on review of the limited amount of material available in the current literature, focal cryoablation can provide acceptable cancer control while preserving sexual potency and urinary continence. Focal cryoablation may fill a void in the therapeutic options available to patients with unifocal or unilateral prostate cancer who have a strong desire to maintain their quality of life.

Focal prostate cryoablation: initial results show cancer control and potency preservation.

BACKGROUND: Focal prostate cryoablation is the less-than-complete ablation of the gland with ice. Known tumor is ablated aggressively, whereas contralateral prostate tissue and surrounding structures are spared. This method offers targeted local cancer control aiming at sexual potency and urinary continence preservation in patients whose prostate cancer is believed to be unilateral. PATIENTS AND METHODS: Patients who had a strong desire for preservation of sexual function and continence were informed of focal prostate cryoablation as an investigational treatment option for clinically organ-confined, unilateral tumor identified by color Doppler ultrasonography and confirmed by targeted and systematic biopsy. Only stage, not preoperative serum prostate specific antigen concentration (PSA) or tumor differentiation, was considered a potential contraindication. Thirty-one men with a mean age of 63 years underwent the procedure. Follow-up consisted of PSA measurement every 3 months for 1 year and every 6 months thereafter, with biopsies at 6 months and 1, 2, and 5 years and following any three consecutive PSA rises. Potency was determined with a patient questionnaire filled in without the physician present. RESULTS: At a mean follow-up of 70 months, biochemical disease-free status, according to the ASTRO definition, was maintained by 92.8% of patients (26/28) and a 96.0% negative-biopsy rate (24/25) was observed. The one biopsy-positive patient was subsequently treated with full-gland cryoablation and remains disease free. Potency was maintained by 48.1% of patients (13/27) and another 40.7% (11/27) were potent with oral pharmaceutical assistance, yielding a total potency-preservation rate of 88.9%. No complications were observed. CONCLUSION: Focal cryoablation can provide biochemical and local control of prostate cancer while preserving potency and continence. Further investigation is needed.

In treating localized prostate cancer the efficacy of cryoablation is independent of DNA ploidy type.

While the prognostic value of DNA ploidy has been well established for radical prostatectomy, external beam radiation, brachytherapy and androgen deprivation therapy its role as a survival outcome predictor for prostate cancer patients treated with cryoablation has not yet been examined. Anecdotal evidence suggesting that cryoablation may be independent of DNA ploidy type led to the implementation of the current study. Retrospective analysis of data including flow digital cytometry was performed on 447 archival specimens taken from patients who had undergone cryosurgical ablation of primary prostate cancer. Five-year biochemical disease free survivals (bDFS) (defined as PSA thresholds of 0.5 and 1.0 ng/ml) were determined with Kaplan-Meier analysis. Patients were grouped according to DNA ploidy types then stratified by Gleason grade, risk group, pre-surgical PSA level, and disease stage. Mean and median age of the cohort was 65 and 64.6 years. Mean follow-up was 65.7 months. The DNA ploidy status of the population was found to be 59% diploid, 13% tetraploid, and 28% aneuploid. Using PSA < 1.0 ng/ml criterion, the bDFS rates for diploid, tetraploid, and aneuploid were 78%, 75%, and 79% respectively. The bDFS rates using a PSA < 0.5 ng/ml criterion were 67%, 59%, and 69% for diploid, tetraploid, and aneuploid groups. No significant outcome differences were found in stratified analysis. This investigation demonstrates that the efficacy of cryoablation is independent of DNA ploidy type.

Salvage cryosurgery for recurrent prostate cancer after radiation therapy: a seven-year follow-up.

Cryosurgery of the prostate presents as an efficient therapy following failed radiation therapy. We report on a 7-year retrospective analysis evaluating the morbidity adn biochemical disease-free survival(bDFS) of this therapy. Between 1993 and 2001, 59 patients who had been previously treated with radiation therapy and had rising serum prostate-specific antigen(PSA) values underwent salvage cryoablation of the prostate for localized, histologically proven, recurrent prostate cancer. Serial serum PSA testing was performed, and biopsies were taken at 6, 12, and 24 months, and again at 5 years, and any time the PSA rose above 0.5 ng/mL. Patients were stratified along clinical parameters. The combined postsalvage bDFS rate using a PSA cutoff of 0.5 ng/mL was 59% and 69% with a 1.0 ng/mL PSA cut off. Using a PSA threshold of 0.5 ng/mL as evidence of biochemical recurrence, 61%, 62%, and 50% of patients with <4 ng/mL, 4-10 ng/mL, and > 10 ng/mL PSA, respectively, remain biochemically relapse free at 7 years. A threshold of 1.0 ng/mL yielded a disease-free status of 78%, 74%, and 46% respectively. Patients biopsies showed no evidence of residual or recurrent disease. Improved survival rates and no known latent complications indicate cryosurgery is a promising form of treatment for radiation-resistant prostate cancer. This 7-year analysis shows a promising validation of cryosurgery as an efficacious treatment modality for locally confined T1-T3 prostate cancer following primary radiation therapy failure.

Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer.

The efficacy and safety of the long-term experience with targeted cryoablation of prostate cancer (TCAP) at a community hospital is retrospectively reviewed. A series of 590 consecutive patients who underwent TCAP as primary therapy with curative intent for localized or locally advanced prostate cancer from March 1993 to September 2001 were identified. Patients were stratified into 3 risk groups according to clinical characteristics. Biochemical disease-free survival (bDFS), post-TCAP biopsy results, and post-TCAP morbidity were calculated and presented. The mean follow-up time for all patients was 5.43 years. The percentages of patients in the low-, medium-, and high-risk groups were 15.9%, 30.3%, and 53.7%, respectively. Using a prostate-specific antigen (PSA)-based definition of biochemical failure of 0.5 ng/mL, results were as follows: (1) the 7-year actuarial bDFS for low-, medium-, and high-risk patients were 61%, 68%, and 61%, respectively; (2) the bDFS probabilities for a PSA cutoff of 1.0 ng/mL for low-, medium-, and high-risk patients were 87%, 79%, and 71%, respectively; and (3) the bDFS probabilities for low-, medium-, and high-risk patients using the American Society for Therapeutic Radiology and Oncology (ASTRO) definition of biochemical failure (3 successive increases of PSA level) were 92%, 89%, and 89%, respectively. The rate of positive biopsy was 13%. After a positive biopsy, 32 patients underwent repeat cryoablation. For those patients who underwent repeat cryoablation, 68%, 72%, and 91% remain bDFS using definitions of 0.5 ng/mL, 1.0 ng/mL, and the ASTRO criteria, respectively, after a mean follow-up time since repeat cryoablation of 63 months. The rates of morbidity were modest, and no serious complications were observed. TCAP was shown to equal or surpass the outcome data of external-beam radiation, 3-dimensional conformal radiation, and brachytherapy. These 7-year outcome data provide compelling validation of TCAP as an efficacious treatment modality for locally confined and locally advanced prostatic carcinoma.