eMedicine Specialties > Urology > Cancer, Prostate

Prostate Cancer - Cryotherapy

Author: Matthew R Cooperberg, MD, MPH, Assistant Professor, Department of Urology, University of California at San Francisco School of Medicine
Coauthor(s): Peter Carroll, MD, FACS, Chair, Professor, Department of Urology, University of California at San Francisco; Katsuto Shinohara, MD, Associate Adjunct Professor, Department of Urology, University of California at San Francisco; Consulting Surgeon, Urology Section, Veterans Affairs Medical Center
Contributor Information and Disclosures

Updated: Apr 27, 2009

Introduction

History of the Procedure

Cryotherapy—the ablation of tissue by local induction of extremely cold temperatures—has its earliest antecedent in 19th-century London, where Arnott applied ice-salt mixtures to cancers of the breast and cervix.1 The 1966 advent of probes cooled by liquid nitrogen in closed circulation marks the beginning of modern cryotherapy.2 One of the first applications of this new technology was the transurethral cryoablation of benign prostatic hyperplastic tissue,3 followed shortly thereafter by the treatment of prostate cancer via an open perineal approach.4 The transperineal approach was introduced in 1974, initially using a single digitally guided cryoprobe repositioned as needed during the procedure.5

Early series of cryotherapy achieved effective tissue ablation, and complications were considered to be less severe than those of radical surgery at the time. The major impediment to early acceptance of the modality, however, was the inability to accurately monitor cryoprobe placement and ice-ball formation.

Major advances in the past 15 years, which have reinvigorated investigation into the use of cryotherapy for prostate cancer, have included the use of real-time transrectal ultrasonography (TRUS) monitoring of probe placement and freezing,6 the simultaneous use of multiple cryoprobes, and the standard use of urethral warming catheters.7

A significant recent development was the introduction of cryotherapy probes that use argon gas rather than liquid nitrogen. Argon rapidly cools the probe tip to -187°C (-304.6°F) and can be rapidly exchanged with helium at 67°C (152.6°F) for an active thawing phase, producing a faster response to operator input and significantly speeding 2-cycle treatment.8 Moreover, argon-based probes have a much smaller diameter, thus permitting direct, sharp transperineal insertion, avoiding the need for tract dilation and facilitating more conformal cryosurgery by allowing placement of more probes.9

In recent years, cryotherapy has seldom been used in community urological practice despite the initiation of Medicare reimbursement for the procedure in 1999. Among 8685 patients followed as of August 2002 in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry (a primarily community-based observational database of patients with prostate cancer treated at 35 practice sites across the United States), less than 2% of those diagnosed with prostate cancer since 1996 underwent cryotherapy as primary treatment.10

According to American Urological Association (AUA) polls, the percentage of urologists performing cryosurgery from 1997-2001 remained constant at 2%, but the average annual number of procedures performed by each urologist increased from 4 to 24. In contrast, the percentage of urologists performing brachytherapy over the same period rose from 16% to 51%, with the annual number of procedures per urologist rising from 15 to 16.5.11 However, ongoing technical advances and recently reported results from academic centers suggest that cryotherapy may be poised to capture an increased role in the management of localized prostate cancer.

In 2008, the AUA published a Best Practice Statement on the use of cryosurgery for the treatment of localized prostate cancer.12

Cryobiology

Cryotherapy exerts its antineoplastic effects via numerous proposed pathways, including direct cytolysis via extracellular and intracellular ice crystal formation, intracellular dehydration and pH changes, ischemic necrosis via vascular injury, cryoactivation of antitumor immune responses, and induction of apoptosis. Endothelial damage leads to platelet aggregation and microthrombosis. Histologic changes, including necrosis, hyalinization, and inflammation, can occur for at least one year following treatment, as can residual indolent cancer. Hyalinization may be more prominent in more effectively treated prostates, ie, those with no residual cancer.13

Additional injury occurs during warming, with osmotic cellular swelling and vascular hyperpermeability. Numerous factors affect the efficiency of tissue destruction, including the velocity of cooling, nadir temperature, the duration of freezing, the velocity of thawing, the number of freeze-thaw cycles, and the existence of large blood vessels, which act as heat sinks. In general, a minimum freezing temperature of -40°C (-40°F) for 3 minutes is believed to be necessary for efficient tumor eradication.14,15,16

Indications

Primary treatment
A 2008 research summary by the Agency for Healthcare Research and Quality (AHRQ) concluded that, because of the lack of relevant randomized controlled trials, whether cryotherapy is more or less effective than other therapies in the treatment of localized prostate cancer is unknown.17 The Best Practice Statement issued by the AUA concluded that level II-2/3 evidence exists to support offering cryotherapy to men with clinically organ-confined prostate cancer with a negative metastatic evaluation finding. In high-risk men, including those with clinical stage T3 disease, data are more sparse; multimodal therapy may be necessary.12

As with any other treatment for prostate cancer, appropriate patient selection is critical, and preprocedure tumor characteristics are strong indicators of outcome. Patients with low-risk tumor features (ie, serum prostate-specific antigen [PSA] level ≤ 10 ng/mL, diagnostic biopsy Gleason score ≤ 6, clinical stage T1c or T2a) are expected to have the best outcomes. Patients with higher-grade, more-extensive, or more-advanced disease are at higher risk for local extension, metastatic spread, or both.

In most contemporary series, cryotherapy is associated with higher rates of impotence than other local treatment alternatives; therefore, patients for whom preservation of erectile function is a high priority are probably less-than-ideal candidates. Cryoablation has, however, been used for local disease control in patients with known metastatic disease on systemic therapy who require palliative maneuvers for local symptoms.18

Larger prostates may be more difficult to treat because of the difficulty in achieving a uniformly cold temperature throughout the gland. Neoadjuvant therapy for downsizing the gland may be considered in such patients.

Salvage treatment

The AUA Best Practice Statement concluded that level II-3 evidence supports the consideration of cryotherapy in men in whom radiation therapy has failed, particularly those with biopsy-proven local persistence or recurrence, clinically localized disease, and a PSA level of less than 10 ng/mL.12

Few local treatment alternatives are available for patients who do not achieve a low PSA nadir or who experience a rising PSA level after radiotherapy. Additional brachytherapy19 and radical prostatectomy20 are options; however, most patients in this position undergo systemic androgen deprivation therapy, which may control the cancer for several years but does not offer the possibility of definitive cure. Cryosurgery has recently been established as a viable alternative for patients in whom radiotherapy has failed. Tumor cells resistant to radiotherapy, androgen withdrawal, and chemotherapy may remain vulnerable to the physical trauma of freezing and thawing.

Candidates for such salvage treatment should be carefully selected. In particular, if the goal is cure, the treating physician must be reasonably confident that the failure of radiation is truly attributable to persistent or recurrent local disease rather than to occult metastatic disease. To this end, inclusion criteria for reported series of salvage cryotherapy have generally included imaging tests (nuclear scintigraphy and pelvic cross-sectional imaging [CT scanning or MRI]) to rule out metastases to the bones and pelvic lymph nodes, respectively. However, the sensitivity of these tests, particularly for lymph node involvement, is less than 50%,21 and the likelihood of positive test results despite a low PSA level is quite low.22

Some investigators have confirmed the presence of viable, treatable local disease via prostate biopsy.23 In patients with high-risk features, such as a preradiation PSA level of more than 20 ng/mL, Gleason score of 8-10, or a rapidly rising PSA level after radiation, a pelvic lymphadenectomy, which can be performed via laparoscopy or minilaparotomy, may be considered.

Independent of prostate cancer, patients should have a life expectancy of at least several years, and they should understand the increased risks of adverse effects in the context of salvage therapy. Most reported procedures have been performed in patients whose conditions have proven refractory to external-beam radiotherapy, but success has also been reported in patients with disease refractory to brachytherapy.23

Subtotal prostate cryotherapy

Interest is growing in focal therapy for prostate cancer, using targeted radiation or energy-based ablation techniques to treat a focus of cancer while sparing the rest of the prostate and surrounding structures. The goal is better quality-of-life preservation among men with low-risk, presumably localized tumors. The primary difficulty is that prostate cancer is frequently multifocal and cannot be reliably identified by any currently available imaging modality. Furthermore, even extended-template biopsies may undersample the prostate, resulting in understaging, undergrading, and/or underappreciation of multifocality.

A few small series of focal, unilateral, or otherwise subtotal cryotherapy have been reported, but this approach should be considered experimental. The AUA Best Practice Statement concluded, based on level III evidence, that cases of subtotal prostate cryosurgery should be described and collected prospectively in a database and studied more rigorously before a treatment recommendation can be made.12

Relevant Anatomy

The prostate gland rests in the pelvis on the urogenital diaphragm, inferior to the bladder, anterior to the rectum (from which it is separated by Denonvilliers aponeurosis [fascia]), posterior to the Retzius retropubic space, and bounded bilaterally by the levator ani musculature. The prostate surrounds the prostatic urethra. It receives its blood supply from the inferior vesical and middle rectal branches of the internal iliac arteries and drains via the Santorini dorsal venous plexus. Innervation is via the pelvic plexus arising from the T10-T12 and S2-S4 nerve roots. The neurovascular bundles run inferolaterally to the prostate and are critical determinants of penile erectile function.

The prostate is divided into zones that describe the ductal drainage systems. The posterior peripheral zone accounts for 70% of the prostate volume and is the location of 60-70% of prostate cancers. The transition zone accounts for only 5% of normal prostate volume but is the site of all benign prostatic hyperplasia and is therefore frequently enlarged. Ten to 20% of prostate cancers are located in the transition zone. The central zone accounts for 25% of prostate volume and is involved in 5-10% of prostate cancers.

Contraindications

Relative contraindications to cryotherapy include the following:

  • Prior transurethral resection of the prostate (TURP) with a large tissue defect
  • Significant symptoms of urinary tract obstruction prior to treatment
  • Large prostate (Even with multiple probes, complete ablation of glands larger than 50 cm3 is difficult, and multiple probe insertions and prolonged freezing times may be required. In these cases, the prostate may be cytoreduced with neoadjuvant hormonal ablation before cryoablation.14 )
  • History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
  • High risk of lymph node metastasis (Cryotherapy is not used to stage or treat pelvic lymph nodes, so patients at high risk of lymph node metastasis may not be ideal candidates for cryotherapy. The AUA Best Practice Statement suggested that such patients may warrant prior or concurrent lymph node dissection.12 These patients may also be more appropriately managed with a different primary treatment modality.)

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References
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Further Reading

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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

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Contributor Information and Disclosures

Author

Matthew R Cooperberg, MD, MPH, Assistant Professor, Department of Urology, University of California at San Francisco School of Medicine
Matthew R Cooperberg, MD, MPH is a member of the following medical societies: American Medical Association and California Medical Association
Disclosure: Nothing to disclose.

Coauthor(s)

Peter Carroll, MD, FACS, Chair, Professor, Department of Urology, University of California at San Francisco
Disclosure: Nothing to disclose.

Katsuto Shinohara, MD, Associate Adjunct Professor, Department of Urology, University of California at San Francisco; Consulting Surgeon, Urology Section, Veterans Affairs Medical Center
Katsuto Shinohara, MD is a member of the following medical societies: American Institute of Ultrasound in Medicine and American Urological Association
Disclosure: Nothing to disclose.

Pharmacy Editor

Francisco Talavera, PharmD, PhD, Senior Pharmacy Editor, eMedicine
Disclosure: eMedicine Salary Employment

Managing Editor

Martin I Resnick, MD †, Former Lester Persky Professor and Chair, Department of Urology, Former Professor, Department of Oncology, Case Western Reserve University School of Medicine
Martin I Resnick, MD † is a member of the following medical societies: American College of Surgeons, American Federation for Medical Research, American Institute of Ultrasound in Medicine, American Medical Association, American Society for Bone and Mineral Research, American Society for Reproductive Medicine, American Society of Andrology, American Surgical Association, American Urological Association, Association for Academic Surgery, Endocrine Society, National Kidney Foundation, Ohio Urological Society, and Pan American Medical Association
Disclosure: Nothing to disclose.

CME Editor

J Stuart Wolf Jr, MD, FACS, David A Bloom Professor of Urology, Director of Division of Minimally Invasive Urology, Department of Urology, University of Michigan
J Stuart Wolf Jr, MD, FACS is a member of the following medical societies: American College of Surgeons, American Urological Association, Catholic Medical Association, Endourological Society, Society for Urology and Engineering, Society of Laparoendoscopic Surgeons, Society of University Urologists, and Society of Urologic Oncology
Disclosure: Terumo Corporation Consulting fee Consulting; Gyrus-ACMI Honoraria Speaking and teaching

Chief Editor

Edward David Kim, MD, FACS, Professor of Surgery, Division of Urology, University of Tennessee Graduate School of Medicine; Consulting Staff, University of Tennessee Medical Center
Edward David Kim, MD, FACS is a member of the following medical societies: American College of Surgeons, American Society for Reproductive Medicine, American Society of Andrology, American Urological Association, and Tennessee Medical Association
Disclosure: Lilly Consulting fee Consulting; Astellas Consulting fee Speaking and teaching; Indevus Consulting fee Speaking and teaching

 
 
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