eMedicine Specialties > Urology > Cancer, Prostate
Prostate Cancer - Cryotherapy: Follow-up
Updated: Apr 27, 2009
Outcome and Prognosis
Local control
Among patients undergoing rebiopsy 3-24 months after treatment with a standard 5-probe cryotherapy system, 7.7-25%58,59,60 have been found to have residual malignant glands, and 42-71%48,14,60 have been found to have focal areas of viable benign epithelium. Numerous disease- and treatment-related factors have been shown to predict rates of local control. In one series, for example, the likelihood of positive biopsy findings was 9% in subjects with clinical stage T1 or T2 disease, compared with 21% in those with T3 disease.61 Persistent or recurrent cancer is more likely among tumors located in the prostatic apex or seminal vesicles than those located in the mid gland or base.53
A 2001 pooled analysis stratified patients into the following risk groups33 :
- Low risk - PSA level less than or equal to 10 ng/mL, Gleason score less than or equal to 6, and clinical stage T1 or T2a disease
- Intermediate risk - PSA level more than 10 ng/mL, Gleason score equal to or more than 7, or clinical stage T2b disease or higher
- High risk - Two or 3 of these adverse risk factors
The distribution of patients among the risk groups was 25%, 34%, and 41%, respectively. The positive biopsy rate in the series was 18% overall: 12% among low- and intermediate-risk patients and 24% among high-risk patients.
The use of 2 freeze-thaw cycles rather than 1 reduced the positive biopsy rate from 64% to 11% in a series of primary cryotherapy patients14 and from 29% to 9% among a group treated with salvage cryotherapy for radiation failure.18 Other technical advances have also produced improvements. One series reported a reduction of the positive biopsy rate from 83% to 10% as a result of introducing the use of thermosensors during treatment50 ; another series reported a positive biopsy rate of only 2.5% by using 6-8 cryotherapy probes rather than the conventional 5 probes.62
Biochemical failure (primary therapy)
Defining biochemical recurrence after local prostate cancer treatment is controversial; by one recent count, 152 different definitions were used in surgical and radiation studies published between 1991 and 2004—53 in prostatectomy series and 99 in radiation series.63 This variation in definition creates great difficulty in comparing outcomes across treatment modalities and is no less of a problem in the case of cryotherapy. PSA thresholds of 0.4, 0.5, and 1 ng/mL have all been used, as have both the original American Society for Therapeutic Radiology and Oncology (ASTRO) definition of 3 consecutive rises after a nadir and the updated Phoenix definition of nadir plus 2 ng/mL.12 The ASTRO and Phoenix definitions tend to delay identification of treatment failure relative to threshold definitions, thereby artificially improving success rates in survival analyses.64,65
No specific definition was endorsed by the AUA Best Practice Statement.12 However, tissue response to cryotherapy should be more rapid than the response to radiation therapy, so a nadir should be reached more rapidly—within 3 months of treatment in most cases following a sharp posttreatment rise. Therefore, threshold definitions may be more appropriate than the ASTRO or Phoenix definitions. Because this treatment modality does not ablate every gland in the prostate at the microscopic level, the target nadir has not been established with certainty, the nadir achieved initially clearly correlates with the eventual disease progression.
Biochemical failure, defined as a rise in PSA level of 0.2 ng/mL after a nadir of less than 0.5 ng/mL, was reported to be lowest in subjects whose PSA nadirs were less than 0.1 ng/mL.53 Similarly, positive biopsy rates were 1.5%, 10%, and 55% in subjects with nadir levels of less than 0.1, 0.1-0.5, and more than 0.5 ng/mL, respectively.
In a pooled analysis with a median follow-up of 24 months, actuarial 5-year biochemical disease-free survival (bDFS) rates were 60%, 45%, and 36% for low-, intermediate-, and high-risk patients based on a PSA threshold of 0.5 ng/mL to define failure, respectively; rates were 76%, 71%, and 45% using a threshold of 1 ng/mL, respectively.33 A report of cryotherapy experiences in a community setting indicated that 84% of the patients reached a PSA nadir of less than 0.4 ng/mL, although the follow-up period was quite short.66
Prepelica et al reported a series of 65 men with high-risk prostate cancer, defined as a PSA level of greater than or equal to 10 ng/mL and/or a Gleason score of greater than or equal to 8. They found an 83.3% bDFS rate based on the ASTRO definition at median 35-month follow-up. Fifty percent of patients achieved a nadir PSA of less than 4 ng/mL, and 35% achieved a nadir of less than 1 ng/mL. The morbidity rate in this study was low, with 2 patients reporting incontinence, 2 patients reporting rectal pain, and 2 patients reporting urinary retention. Of note, roughly two thirds of the patients in this cohort had received neoadjuvant hormonal therapy, the survival impact of which is still unclear in association with cryotherapy.67
One of the larger series of patients to date, with the longest follow-up, included 590 subjects followed for a mean of 5.4 years. The reported 7-year bDFS rates were stratified by the same risk definitions used by Long et al33 but used several different definitions. Using an absolute PSA threshold of 0.5 ng/mL to define failure (as in many surgical series), the bDFS rates were 61%, 68%, and 61% for low-, intermediate-, and high-risk subjects.40 Adapting the ASTRO definition of failure (ie, 3 successive rises in PSA level), the bDFS rates were 92%, 89%, and 89%. Thirteen percent of subjects had positive biopsy findings; of these, 32 underwent repeat cryoablation, with 7-year bDFS rates comparable to those who had primary cryoablation only: 68% using the 0.5 ng/mL threshold and 91% using the ASTRO definition. Relatively few late failures occurred beyond 24-36 months.40
Jones et al42 recently published the largest series of patients undergoing cryotherapy as primary treatment, all of whom were included in the industry-sponsored Cryo On-Line Data (COLD) registry: 1198 men managed by 27 physicians. The median pretreatment PSA level was 6.8 ng/mL (mean, 9.6 ± 8.6 ng/mL), and various Gleason scores were represented (median, 7). Of note, 49.5% of these men received hormone therapy prior to cryoablation. The mean follow-up period was 24.4 ± 25.9 months.
Five-year actuarial biochemical recurrence-free survival rates were reported to be 77.1% ± 2.1% and 72.9% ± 2.1% using the ASTRO and Phoenix definitions, respectively. Risk-stratified outcomes are listed in the below table. One caveat is that this report somewhat misuses the Phoenix definition, which is intended to predict outcomes only at a point 2 years short of median follow-up; thus, to report 5-year outcomes, 7 years of follow-up should be available.68 Therefore, outcomes may be expected to worsen somewhat with further follow-up.
Study Outcomes
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Table
Study | Number of Patients | Residual Cancer, % | Median Follow-up Period | bDFS Criterion | bDFS, % |
Onik et al 6 | 23 | 17 | 3 mo | | |
Miller et al 69 | 62 | 21 | 3 mo | | |
Bahn et al 58 | 130 | 8 | . . . | | |
Coogan et al 56 | 87 | 17 | 1 y | £ 0.2 ng/mL | 33 |
Wieder et al 52 | 61 | 13 | 3 mo | <0.5 ng/mL | 57 |
Bales et al 48 | 23 | 14 | 1 y | <0.3 ng/mL | 14 |
Shinohara et al 14 | 102 | 23 | 3 mo | <0.1 ng/mL | 48 |
Wake et al 59 | 63 | 25 | 3 mo | <0.1 ng/mL | 25 |
Cohen et al 45 | 383 | 18 | 2 y | <0.4 ng/mL | 55 |
Pisters et al 18 | 150 | 18 | | <0.2 ng/mL | 46 |
Lee et al 62 | 81 | 3 | | | |
Gould 70 | 27 | | 6 mo | <0.2 ng/mL | 96 |
Long et al 33 | 975 | 18 | 24 mo | <0.5 ng/mL | 60 (low risk), 45 (intermediate risk), 36 (high risk) |
Bahn et al 40 | 590 | 13 | 5.4 y | <0.5 ng/mL | 61 (low risk), 68 (intermediate risk), 61 (high risk) |
Han et al 54 | 106 | . . . | 1 y | <0.4 ng/mL | 75 (78 low risk, 71 high risk) |
Prepelica et al 67 | 65 (all high-risk) | . . . | 35 mo | ASTRO | 83 |
Cresswell et al 71 | 51 | . . . | 9 mo | <0.5 ng/mL | 79 |
Jones et al 42 | 1198 | 14.5/38.4 | 2 y | ASTRO/Phoenix | 85 (low risk), 73 (intermediate risk), 75 (high risk) |
Study | Number of Patients | Residual Cancer, % | Median Follow-up Period | bDFS Criterion | bDFS, % |
Onik et al 6 | 23 | 17 | 3 mo | | |
Miller et al 69 | 62 | 21 | 3 mo | | |
Bahn et al 58 | 130 | 8 | . . . | | |
Coogan et al 56 | 87 | 17 | 1 y | £ 0.2 ng/mL | 33 |
Wieder et al 52 | 61 | 13 | 3 mo | <0.5 ng/mL | 57 |
Bales et al 48 | 23 | 14 | 1 y | <0.3 ng/mL | 14 |
Shinohara et al 14 | 102 | 23 | 3 mo | <0.1 ng/mL | 48 |
Wake et al 59 | 63 | 25 | 3 mo | <0.1 ng/mL | 25 |
Cohen et al 45 | 383 | 18 | 2 y | <0.4 ng/mL | 55 |
Pisters et al 18 | 150 | 18 | | <0.2 ng/mL | 46 |
Lee et al 62 | 81 | 3 | | | |
Gould 70 | 27 | | 6 mo | <0.2 ng/mL | 96 |
Long et al 33 | 975 | 18 | 24 mo | <0.5 ng/mL | 60 (low risk), 45 (intermediate risk), 36 (high risk) |
Bahn et al 40 | 590 | 13 | 5.4 y | <0.5 ng/mL | 61 (low risk), 68 (intermediate risk), 61 (high risk) |
Han et al 54 | 106 | . . . | 1 y | <0.4 ng/mL | 75 (78 low risk, 71 high risk) |
Prepelica et al 67 | 65 (all high-risk) | . . . | 35 mo | ASTRO | 83 |
Cresswell et al 71 | 51 | . . . | 9 mo | <0.5 ng/mL | 79 |
Jones et al 42 | 1198 | 14.5/38.4 | 2 y | ASTRO/Phoenix | 85 (low risk), 73 (intermediate risk), 75 (high risk) |
Salvage therapy
Patients who experience disease progression after radiation therapy have few options for potentially curative therapy. Cryotherapy has been offered to such patients if they have no evidence of metastatic disease and their progression is thought to be restricted to persistent or recurrent local cancer. Contemporary series have demonstrated promising results for this treatment approach. Using 2 freeze-thaw cycles, a negative biopsy rate of 93% and a biochemical failure-free survival rate of 66% was achieved in a series of 150 subjects,18 although these results came at the price of higher complication rates.51 Subjects with preoperative PSA levels of more than 10 ng/mL or biopsy Gleason scores of more than 8 were most likely to experience disease recurrence.18
A biochemical failure-free survival rate of 66% at 12 months was reported in a series of 43 salvage patients, with lower complication rates37 ; additionally, a PSA nadir of more than 0.1 ng/mL following treatment predicted eventual recurrence.37 With the use of an argon-based cryosurgery system to treat 38 patients with biochemical recurrence after radiation, PSA nadirs less than 0.1 ng/mL were reported in 81.5% and bDFS rates of 86% and 74% were reported at 1- and 2-year follow-up, respectively.47
In a large series, also using an argon-based system, 118 subjects with recurrent disease after radiation therapy underwent cryoablation, including 5 who had received permanent interstitial implants.23 Negative biopsy findings were reported in 94% of these patients; the 7 who had persistent disease underwent second ablation procedures. Ninety-seven percent had PSA nadirs less than 0.5 ng/mL; at a median of 18.6 months of follow-up, 34% remained below this level (68% had PSA levels <4 ng/mL). Ten patients had developed metastatic disease.23 As in Pisters and colleagues' 1997 study,18 preprocedure PSA levels of more than 10 ng/mL, Gleason scores of more than 8, and stage T3-T4 disease predicted biochemical failure.
Pisters et al recently reported outcomes for salvage cryotherapy among 279 men from the COLD registry, the largest salvage series to date. These patients had significant recurrent/persistent disease, with a mean precryotherapy PSA level of 7.6 ± 8.2 ng/mL and a mean Gleason score of 7.5. Fifty-one percent of these patients received hormone therapy prior to cryotherapy, for a mean of 13 months.
After a follow-up duration of 21.6 ± 24.9 months, 17% of the patients had a PSA level of less than 0.2 ng/mL at 5 years of follow-up. The actuarial biochemical recurrence-free survival rate was 58.9% ± 5.7% and 54.5% ± 4.9% at 5 years using the ASTRO and Phoenix definitions, respectively. Forty-six patients underwent biopsy after cryotherapy; results were positive in 32.6%.55 It should be noted that the follow-up in this study, as in the COLD registry study of primary therapy,42 was insufficient to properly report 5-year outcomes using these definitions.68
Multiple prostate cancer studies over the past few years have generated increased awareness of the importance of PSA kinetics, which are assessed with measurements such as PSA velocity (PSAV) and PSA doubling time (PSADT) at various stages of prostate cancer management. To date, only one study has examined PSA kinetics in relation to cryotherapy. Spiess et al analyzed 49 patients undergoing salvage cryotherapy for failure after radiation therapy for predictors of biochemical outcomes. They found that both precryotherapy PSA levels of greater than 10 ng/mL and a PSADT of less than or equal to 16 months predicted biochemical recurrence after cryotherapy.72
Of note, the median presalvage PSA level was 5.9 ng/mL, and 51% of the patients had a preradiation Gleason grade of 8 or greater.72 Studies of salvage radiotherapy following surgery have found consistently that PSA level at time of radiotherapy predicts outcome,73 as have studies of salvage prostatectomy following radiation therapy failure.74 Thus, earlier use of cryotherapy at lower postradiation PSA levels may improve outcomes, but this issue has not yet been studied in depth.
Longer-term salvage data are also becoming available. Bahn et al reported on 7-year outcomes for 59 patients treated with cryotherapy for failure after radiation. The bDFS rate was 59% using a PSA threshold of 0.5 ng/mL and 69% using a threshold of 1 ng/mL. Notably, no patient had local recurrence upon repeat biopsy; all failures were presumably due to distant progression.75
Future and Controversies
Developments in technology have rekindled interest in cryotherapy as a viable alternative to other, more standard local therapies. Outcomes have now been reported as late as 7 years following treatment and seem to compare favorably with contemporary series of patients who receive radiation therapy, particularly with respect to late failure rates40 and among higher-risk patients.33 Note, however, that even the largest cryotherapy studies have been retrospective examinations of largely single-institution experiences. Moreover, they used disparate definitions of clinical risk, biochemical failure, continence, and potency. These definitions all need to be standardized for cryotherapy.
For fair comparisons to be made with other modalities, prospective studies, ideally randomized, must be conducted; such studies should use consistent definitions, even across treatment modalities, and must control for clinical risk parameters. Given the relative paucity of alternatives for patients who experience biochemical progression after radiotherapy, cryosurgery may also prove a good alternative for those whose tumors appear to remain localized despite progression.
A number of improvements in technology and clinical algorithms may be expected to facilitate ongoing improvements in cryotherapy outcomes in terms of cancer control and quality of life. Varying the intensity and extent of cryoablation should allow patients and physicians to contemplate tradeoffs between quality of life and cancer control certainty. Gould,70 for example, has described a technique of total cryosurgery, in which no urethral warming catheter is used and the urethra is intentionally ablated along with the entire prostate gland. He achieved PSA nadirs of less than 0.2 ng/mL at 6 months in 96% of his patients compared with 49% for standard cryotherapy and 73% for a contemporary series of patients who underwent radical perineal prostatectomy.
This degree of biochemical control came at the cost of obstruction that required transurethral resection in most patients and significant incontinence in 18.5%.70 A novel simulator system, which promises to facilitate training in cryosurgical techniques, has recently been introduced.76
At the other frontier, Rukstalis et al have suggested that prostate parenchyma-sparing cryosurgery may improve outcomes in terms of continence and potency. Despite the multifocal nature of prostate cancer, in an analysis of 112 radical prostatectomy specimens, they found that assuming the largest tumor would be the one detected by biopsy, restricting treatment to 9 of 12 prostate zones, and thereby sparing the contralateral neurovascular bundle, could be accomplished with a 21% risk of significant (ie, >0.5 mL) residual disease.77 Onik et al have tested a similar approach in a small series of 9 patients treated with focal, unilateral nerve-sparing cryotherapy; with a mean follow-up of 36 months, all had stable PSA levels, 6 patients had biopsy specimens with negative findings, and 7 of the 9 were potent.78
In a pilot program at the University of California at San Francisco, 8 patients with localized prostate cancer likewise have been treated with unilateral cryotherapy. All are disease-free, either based on PSA criteria or based on negative biopsy results. No patient developed a urethral fistula or significant tissue sloughing. Significantly, although only 2 of the patients were potent before treatment, both reported no change in their erections after the limited cryosurgical treatment (N. Rahman, MD, unpublished data, June 2005). Onik et al reported on a larger series (55 men) who underwent treatment only of the area of the prostate known to harbor cancer. With a mean of 3.6 years follow-up, 95% had stable PSA levels (ASTRO definition), and 86% of potent patients retained their erectile function.79 While such approaches should still be considered experimental, they hold significant promise as the indications and approaches to focal therapy continue to evolve.
Innovative combination therapy may also play a role in the future. Clarke et al have reported in vitro data suggesting that the combination of 5-fluorouracil (5-FU) and cryotherapy produces efficient prostate cancer cell death at temperatures as high as -15°C, via a mix of necrosis, Bax-mediated apoptosis, and freeze rupture. In theory, this approach to chemo-cryotherapy could improve oncologic outcomes by achieving more uniform tumor death, while decreasing adverse effects by reducing the ice-ball size required to achieve a higher target temperature.80,81,82 Other biological response modifiers, such as antifreeze proteins, may also improve the efficiency of the freezing process,83 as may improved imaging modalities.
Finally, a major goal of prostate cancer research in general is the identification and development of pretreatment prognostic indicators based on biopsy tissue, serum, and/or urine, which can predict with better accuracy the likely natural history of a given patient's tumor. Patients with low risks of disease progression would be candidates for active surveillance alone, whereas those with more aggressive tumor characteristics could receive early, multimodal therapy. Given all the progress that has been made in the past decade, cryosurgery will likely play an increased role in the future management of prostate cancer.
Prostate cancer screening
Despite the apparent survival advantage of early diagnosis conferred by PSA screening, a recent U.S. Preventive Services Task Force statement recommends against screening for prostate cancer in men aged 75 years or older. The statement also concludes that, currently, the balance of benefits versus drawbacks of prostate cancer screening in men younger than age 75 years cannot be assessed because of insufficient evidence.84
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Further Reading
Keywords
cryotherapy, prostate cancer, cryoablation, cryosurgery, cryoprobes, urethral warming catheters, brachytherapy, radiotherapy, radiation therapy, radical prostatectomy, systemic androgen deprivation therapy, transrectal ultrasound, TRUS, transurethral resection of the prostate, TURP, transurethral cryoablation, pelvic lymphadenectomy, neoadjuvant androgen ablation, prostate-specific antigen, PSA, benign prostatic hyperplasia, BPH, erectile dysfunction, ED, impotence, potency, incontinence, continence, penile numbness, rectourethral fistula, urethral stricture, hydronephrosis, small bowel obstruction
