Cryosurgical ablation of the prostate: two-year prostate-specific antigen and biopsy results. Cryosurgical ablation of the prostate: 5-year follow-up of a prospective study. Preliminary outcomes following cryosurgical ablation of the prostate in patients with clinically localized prostate carcinoma. Percutaneous cryoablation of the prostate: preliminary results after 95 procedures. Total cryosurgery of the prostate versus standard cryosurgery versus radical prostatectomy: comparison of early results and the role of transurethral resection in cryosurgery. Cryosurgery as a treatment for prostate carcinoma: results and complications. Prospective trial of cryosurgical ablation of the prostate: five-year results. Cryosurgical ablation of the prostate: high risk patient outcomes. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer.
Percutaneous cryosurgical ablation of the prostate (CSAP) was performed on patients with localized or locally advanced adenocarcinoma of the prostate. To assess local disease control, post-treatment biopsy and serum prostate-specific antigen (PSA) levels were obtained at 3 and 24 months post-treatment.
                From June 1990 through May 1994, CSAP was performed 448 times on 383 patients under Institutional Review Board protocols. A urethral warming catheter was used for all procedures. A total of 239 patients were followed for a minimum of 21 months after treatment. None of this group had received prior local treatment. The group consisted of patients who were newly diagnosed and treated solely with cryotherapy (virgin); the remainder had been on androgen deprivation therapy (ADT) prior to CSAP.
                Biopsies were obtained from 114 patients at 21 months or more after treatment. In the virgin group, 79% had a negative biopsy after one or more treatments, and 88% of the ADT group are negative after one or more treatments. Overall, 69% had a negative biopsy after one treatment and 82% had a negative biopsy following one or more CSAP treatments. Of a group of 163 patients, PSA data were evaluable at 21 months or more after treatment. In the virgin group, 60% had a PSA 0.4 ng/mL or less, and 77% had a PSA 1.0 ng/mL or less. In the ADT group, 40% had a PSA 0.4 ng/mL or less, and 69% had a PSA value of 1.0 ng/m Lor less. Complications were minimal, the most common one being urethral tissue sloughing, which occurred in 10% of patients.
                CSAP appears to be effective in obtaining local control as measured by biopsy and PSA 21 months or more post-treatment. When retrospectively comparing our results with recently published radiotherapy series, CSAP was more effective in obtaining nadir PSA values 1.0 ng/mL or less and negative biopsies at 21 months or more after treatment. To study the complications and oncological outcome after cryosurgical ablation of the prostate (CSAP).
                Fifty-four patients with prostate cancer were entered into this prospective phase II trial of CSAP. Patients were followed with serum PSA determinations, follow-up biopsies at 3-6 months postoperatively and a questionnaire to assess complications. A PSA of >1 ng/ml or a positive biopsy was interpreted as progression.
                Mean follow-up was 58.5 months. Patients needed a suprapubic catheter postoperatively for in mean 18 days. Transient penile numbness occurred in 15%. Bothersome sloughing of dead tissue was noticed by 15% of patients and 15% needed a transurethral resection. Nine patients (17%) developed strictures and five patients stone formation in the prostatic urethra. One patient developed a perennial fistula. Thirty-nine out of 43 patients reporting on potency become impotent, nine patients developed a slight stress incontinence and one severe incontinence.At median follow-up, the actuarial progression-free survival was 38.9%. Fourteen out of 50 patients biopsied (28%) had remaining cancer in their prostates.
                High complication rates in combination with poor oncological outcome has made us stop using this treatment modality. Cryosurgical ablation of the prostate is a novel therapeutic modality that induces cell lysis in the prostate by direct application of low temperatures. We have been conducting an ongoing prospective pilot study of the use of cryosurgical prostate ablation in treating patients with nonmetastatic prostate adenocarcinoma since January 1993. Results in 145 consecutive patients with mean 36 months and minimum 12 months of followup are presented.
                Accrual was open to patients with clinical stages T1a to T3c prostate adenocarcinoma. Pelvic lymph node dissections were recommended but not required for patients with prostate specific antigen (PSA) greater than 15 ng./ml. before study entry. PSA changes, random prostate biopsy findings and morbidities after cryosurgical prostate ablation were recorded for each patient.
                Overall actuarial rates at 42 months for maintaining PSA less than 0.3 and less than 1.0 were 59% and 66%, respectively. The overall actuarial progression-free rate at 60 months was 56%. Among 160 biopsies performed 16% showed some evidence of residual carcinoma. Overall crude rates of maintaining either a negative biopsy or PSA less than 0.3 at 6 and 24 months after cryosurgical prostate ablation were 87% and 73%, respectively. Significantly higher morbidities were seen in previously radiated patients undergoing cryosurgical prostate ablation compared to those with no prior radiation. Among nonradiated patients 85% experienced no significant morbidity after cryosurgical prostate ablation.
                Although preliminary, short-term outcomes after cryosurgical prostate ablation appear to be comparable to identical outcomes reported for external beam radiotherapy. Based on these results cryosurgical prostate ablation appears to be an effective therapeutic alternative for treating patients with localized prostate adenocarcinoma. We examined the role of percutaneous cryoablation of the prostate in the treatment of prostate cancer.
                We performed 95 percutaneous cryoablations of the prostate on 87 patients with prostate cancer. Of the patients 6 had positive lymph nodes preoperatively, radiation failed in 9 and 9 began postoperative hormonal therapy because of treatment failure. Mean patient age, prostate specific antigen (PSA) level (ng./ml.) and Gleason score were 65.4, 12.60 and 6.03, respectively. Median followup was 12 months (mean 9.3, range 1 to 24). In 49 of the 87 patients (56%) the lymph nodes were evaluated before cryoablation based on the treatment protocol.
                Median PSA level at 12 months was 0.55 ng./ml. (mean 1.73) with a 17% positive biopsy rate at 3 months. When the positive lymph node, radiation failure and postoperative hormonal therapy groups were removed from analysis, the median PSA level was 0.80 ng./ml. (mean 1.86) with a 5% positive biopsy rate. Of the patients in the radiation failure group 37% had a positive biopsy at 3 months. Cases were classified according to stage, grade and PSA level, and the biopsy results were presented. The complications of percutaneous cryoablation of the prostate were reviewed.
                The low percentage of positive biopsies is encouraging but the significance of the persistent PSA levels remains uncertain. Results of standard cryosurgery of the prostate for prostate cancer in 49 patients were compared to those of destruction of the urethra during or after cryosurgery with subsequent transurethral resection or total freezing of the prostate (total cryosurgery) in 27. These results were compared to those of radical surgery in 83 patients with similar age, stage and grade of disease, and prostate specific antigen (PSA).
                The 76 cryosurgery cases included all of those treated by 1 surgeon (R. S. G.) for localized prostate cancer after July 1, 1995. The 83 radical perineal prostatectomy cases consisted of all of those treated by another surgeon during the study period and by R. S. G. before cryosurgery use. Success was defined as a PSA of 0.2 or less 6 months after the procedure and a stricter standard, 0.0 PSA, was also assessed.
                The success rate was 96% for total cryosurgery, 48.9% for standard cryosurgery and 73.4% for radical surgery. Using 0.0 PSA as a criterion, 66.7% of total cryosurgery, 16.3% of standard cryosurgery and 48.2% of radical surgery cases were successfully treated.
                Total cryosurgical destruction of the prostate may offer new opportunities for cancer treatment heretofore unrecognized and should undergo more investigational analysis. There has been a resurgence of interest in cryosurgical ablation of the prostate for the treatment of carcinoma. This is due to recent advances in cryosurgical technology, which have resulted in relatively lower morbidity. The objective of this study was to evaluate the effectiveness of ultrasound-guided cryosurgical ablation of prostate carcinoma.
                Eighty-three patients who had biopsy-proven prostate carcinoma underwent cryosurgical ablation of their entire prostate gland. The initial group of 12 patients had their procedures performed under ultrasound guidance only. The other 71 patients had cryosurgery performed with temperature monitoring in combination with ultrasound guidance. Twelve patients who had positive biopsies underwent a second cryosurgical procedure. All patients had prostate specific antigen (PSA) levels measured at 3, 6, 12, 18, 24, and 30 months after cryosurgery. Ultrasound-guided sextant biopsies were performed at 3-6, 12-18, and 24 months.
                The median PSA dropped by 95%, from a preoperative value of 4.3 ng/mL to 0.2 ng/mL 30 months after cryosurgery. The authors experienced a high failure rate (positive biopsies) of 83% for the initial group of 12 patients who did not have temperature monitoring during the cryosurgical procedure. This was in contrast to a success rate of 90% (negative biopsies) for the next 71 patients, who did have temperature monitoring (P < 0.05, chi-square test). Twelve patients underwent a second cryosurgery, and the success rate for this group was 91% (11 of 12 patients). The combined success rate for both the first cryosurgery and the second was 94% (62 of 77 patients). Complications included urethral sloughing, urinary incontinence, impotence, bladder neck contracture, and bladder contracture. The majority of patients recovered rapidly from their cryosurgical procedures and were able to resume normal activities 3-4 weeks afterward.
                These preliminary results demonstrate that cryosurgical ablation of the prostate is a viable treatment option for prostate carcinoma. In the authors' experience, ultrasound alone may not be adequate for monitoring the entire cryosurgical procedure. The authors found that temperature monitoring shortened their learning curve, enabled them to freeze prostate tissue more aggressively, and may have contributed to their overall success. To determine in a prospective pilot study the safety and efficacy of cryosurgical ablation for localized prostate carcinoma.
                A total of 87 cryosurgical procedures were performed on 76 consecutive patients between December 1994 and February 1998. All patients had histologically proved adenocarcinoma of the prostate, with prostate-specific antigen (PSA) readings of less than 30 ng/mL. Clinical evaluations, PSA determinations, and patient self-reported quality-of-life questionnaires (functional assessment of cancer treatment-prostate; FACT-P) were used to determine biochemical and clinical disease-free status and complications. Patients had a mean follow-up of 50 months (minimum 36).
                Follow-up biopsies were performed in 73 patients, and 72 were negative for malignancy after one or more treatments. Ten patients required two treatments and 1 patient required three treatments. The 5-year overall and cancer-specific survival rate was 89% (95% confidence interval, 83% to 97%) and 98.6% (95% confidence interval, 96% to 100%), respectively. The undetectable PSA rate (less than 0.3 ng/mL) for low-risk patients (n = 13) was 60% at 5 years; for moderate-risk patients (n = 23), it was 77%, and for high-risk patients (n = 40), 48%. The corresponding percentage of patients with a PSA level less than 1.0 ng/mL at 5 years was 75%, 89%, and 76%. Sloughing occurred in 3 patients (3.9%), incontinence in 1 (1.3%), and testicular abscess in 1 (1.3%). At 3 years, 18 (47%) of 38 patients capable of unassisted intercourse at the time of cryosurgery had resumed sexual intercourse, 5 spontaneously and 13 with sildenafil or prostaglandin.
                The results of this prospective evaluation show cryosurgery to be both a safe and an effective option in the treatment of localized prostate cancer. The authors report their experience with cryosurgical ablation of the prostate in men with high-risk features for prostate carcinoma who were unwilling to undergo radical surgery or radiation therapy.
                Between January 1998 and April 2002, 65 men underwent primary cryosurgery for prostate carcinoma with high-risk features. All patients had biopsy-proven prostate carcinoma without evidence for metastatic disease on magnetic resonance images, computed tomography scans, or radionuclide images of bones. High-risk parameters were defined as either a prostate-specific antigen (PSA) level >/= 10 ng/mL, or a Gleason sum score >/= 8, or both. Patients who had undergone prior surgery, radiation therapy, or cryoablation for prostate carcinoma were excluded from the study. Patients were monitored with physical examination and PSA screening every 3 months and with radiologic imaging when indicated.
                The median patient age was 72 years (range, 41-86 years), and t he median follow-up was 35 months (range, 4-77 months). There were 2 patients (3.1%) with rectal pain and incontinence. Durable PSA biochemical disease-free survival was noted in 83.3% of patients according to the American Society for Therapeutic Radiology and Oncology (ASTRO) criteria. A 6-year Kaplan-Meier analysis revealed an 81.7% ASTRO survival probability as well as PSA nadir < 4.0 ng/mL and PSA nadir < 1.0 ng/mL projections of 50% and 35%, respectively. One of 8 postcryosurgery biopsies (12.5%) were positive. No patient had progressed at last follow-up, and the overall survival rate was 100%.
                Cryoablation was a feasible treatment option in patients with organ-confined prostate carcinoma who had high-risk features. Longer follow-up will be necessary to determine the effectiveness of this approach.
                (c) 2005 American Cancer Society. 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.
Cryotherapy offers a potential alternative to standard therapies for the primary treatment of localised prostate cancer. However, the poor quality of the available studies makes it difficult to determine the relative benefits of this modality. Randomised trials are needed to fully evaluate the full potential of cryotherapy in men with this disease. Patients selecting cryotherapy as their therapeutic option should be made fully aware of the reported efficacy, complications and the low-grade evidence from which these data are derived.