Table C8Outcomes after cryosurgical prostatectomy in patients with localized prostate cancer

Reference DesignPopulation Followup Definition of OutcomeTreatmentOutcomeOccurrence
Aus, 2002 21 54 patients without metastases, mean age 68 years, mean PSA 26 ng/mlLiquid nitrogen system CMS AccuProbe 450 (CryoMedical Science Inc., Rockville, MD).Progression free survival19 (38.9%)
Prospective phase noncontrolled II trial40.7% with T >2, 37.04% with Gleason scores >7, median followup 58.5 months.The total operation time 90–180 minutes, mean 148 minutes, freezing time 33 minutes, length of stay 1.2 daysTissue sloughing14.81%
Treatment failure: positive biopsy or a serum PSA of >1 ng/mlTURP resection of sloughed tissue14.81%
Stricture16.67%
Stone formation in prostatic urethra9.26%
Urinary tract infection33.33%
Perennial fistula/prostatic abscess1.85%
Self reported impotence72.22%
Self reported potency7.41%
Not reported potency20.37%
Incontinence
Severe (>2 pads per day)1.85%
Mild (1–2 pads per day)16.67%
Lee, 1994 22 210 patients with localized or locally advanced prostate cancer3.4 mm diameter cryoprobes (Endocare, Inc., Irvine, CA) inserted transperineally into the prostate under the transrectal ultrasound controlUrethrorectal fistula2.4%
Case seriesBladder outlet obstruction3%
Incontinence9%
Impotence40%
Total complications14%
Bahn, 2002 23 590 consecutive patients with localized or locally advanced prostate cancer, mean age 70.76 years, 1.8% - T1, 78.1% - T2, 52.5% with Gleason score of 7, and 6% >7, mean followup 5.43 years, Treatment failure: PSA level >1 and >0.5 ng/ml3.4 mm diameter cryoprobes (Endocare, Inc., Irvine, CA) inserted transperineally into the prostate under the transrectal ultrasound control.Biochemical disease free survival89–100%
Case seriesAndrogen ablation therapy 91.5% before treatment 3 months to 1 year before cryoablationPSA <0.5Low risk group (T1–2)
12 months 19.49%
24 months 16.53%
36 months 15.47%
48 months 14.62%
60 months 12.92%
72 months 9.53%
84 months 6.78%
Impotency of 373 potent before surgery354 (94.9%)
16.4 months after surgery19 (5.1%)
Incontinence4.3%
TURP5.5%
Fistula<0.1%
Cohen, 1996 24 383 patients with localized or locally advanced prostate cancerCryoprobes (3 mm in diameter) were placed percutaneously with a transperineal approach. Cryoprobe placement and freezing were monitored using the transrectal ultrasound% positive biopsy16%
Non controlled clinical trial28% with T >2, 7.9Initial PSA ng/ml in A stage9.7
Mean PSA 10 ng/mlPost treatment Mean PSA ng/ml0.73–1.7
53% with Gleason ≥7, 7 (>8)Urethrorectal fistula0.4%
Tissue sloughing9.8%
Urethral stricture2.2%
Bladder outlet obstruction3%
Incontinence4%
Perineal pain0.4%
Urinary tract infection2.2%
Epididymitis1.6%
Sepsis0.7%
Urethral obstruction2%
Coogan, 1995 25 95 percutaneous cryoablations of the prostate on 87 patients with prostate cancer, mean age 65.4, mean PSA 12.60 ng/ml, mean Gleason score 6.03, median followup 12 monthsCryoprobes (3 mm in diameter) were placed percutaneously with a transperineal approach. Cryoprobe placement and freezing were monitored using the transrectal ultrasound.% positive biopsy16–38%
Non controlled clinical trialMean operative time was 129 minutes, mean length of stay 16 daysMean PSA ng/ml1.58–3.22
T13.55
T21.9
Urethrorectal fistula1%
Tissue sloughing10%
Urethral stricture1%
Bladder outlet obstruction6%
Incontinence3.5%
Impotence47%
Perineal pain1%
Urinary tract infection4%
Urethral obstruction2%
Cox, 1995 26 Retrospective review of the charts of 63 patients (69 procedures) performed in a single centerCryoprobes (3 mm in diameter) were placed percutaneously with a transperineal approach. Cryoprobe placement and freezing were monitored using the transrectal ultrasoundUrethrorectal fistula3%
Case seriesTissue sloughing19%
Urethral stricture3%
Bladder outlet obstruction29%
Incontinence27%
Perineal pain11%
Sepsis3%
Urethral obstruction13%
Total complications59%
Number of operations43%
Transient ischemic attack2%
Cerebrovascular accident2%
Donnelly, 2002 27 76 consecutive patients with adenocarcinoma of prostate mean age 65 years, 12% with T >2, mean PSA ng/ml 13, 56% Gleason ≥7, followup 50 months. Treatment failure: PSA > 1 ng/mlMultiple percutaneous cryoprobes (5) were placed under TRUS guidance percutaneously and transperineally into the prostateProgression free survival60–75%
Prospective pilot noncontrolled clinical trial% positive biopsy1.4%
Mean PSA ng/ml0.3–0.9
Sloughing3 (3.9%)
Incontinence1 (1.3%)
Testicular abscess1 (1.3%)
Ellis, 2002 28 75 patients with localized prostate cancer, 21% with T >2, mean PSA ng/ml 8.5, 55% Gleason ≥7Multiple percutaneous cryoprobes (6) were placed with Cryocare System, (Endocare, Inc., Irvine, CA), a cryosurgical device with 8 cryoprobe ports and an integrated temperature monitoring systemProgression free survival84%
Case seriesMean PSA ng/ml0–0.23
Tissue sloughing6.7%
Incontinence5.5%
Impotence82.4%
Koppie, 1999 29 176 patients with clinically localized (stages T1 to T4) prostate cancer, 35.8% with T >2, mean PSA ng/ml 18.4, 20% Gleason ≥7; 57% received neoadjuvant androgen deprivation; Treatment failure: PSA >0.5 ng/ml and increased by more than 0.2 ng/ml on 2 consecutive occasions. Mean followup 30.8 monthsThe prostate was frozen with a multiprobe cryosurgical device. 5 probes were placed with ultrasound monitoringProgression free survival in T1–2
Case seriesAt 1 year82%
At 3 years60%
Long, 1998 30 145 consecutive patients with nonmetastatic prostate adenocarcinoma; Androgen deprivation was used for 3 to 8 months before the procedure in 30% of patients. 28% with T >2, mean PSA ng/ml 10, 53% Gleason ≥7, followup 60 months. Treatment failure: PSA >0.3Multiple percutaneous cryoprobes (5–8) were placed to ablate the entire prostate with real-time transrectal ultrasound monitoringProgression free survival56%
Prospective pilot noncontrolled trialPositive biopsy21%
Urethrorectal fistula1.3%
Tissue sloughing8.9%
Urethral stricture3.4%
Bladder outlet obstruction17.2%
Incontinence2%
Impotence88%
Perineal pain2.3%
Urinary tract infection2.3%
Epididymitis1.5%
Sepsis<1%
Urethral obstruction4.8%
Total complications17%
Number of operations17%
Any treatment21%
Shinohara, 1996 31 102 patients underwent cryosurgery as definitive therapy for localized prostate cancer, 57% with T >2, mean PSA ng/ml 21.8, 54% Gleason ≥7, followup 12 monthsMultiple percutaneous cryoprobes were placed to ablate the entire prostate with real-time transrectal ultrasound monitoringProgression free survival74%
Case seriesUrethrorectal fistula1%
Tissue sloughing23%
Bladder outlet obstruction23%
Incontinence15%
Impotence86%
Perineal pain3%
Urinary tract infection3%
Epididymitis3%
Sepsis3%
Urethral obstruction4%
Shinohara, 1997 32 134 patients underwent 147 cryosurgical ablation procedures for localized prostate cancer. 35.1% with T >2, mean PSA ng/ml 19, 46.4% Gleason ≥7 biochemical failure: PSA nadir ≥0.5 ng/ml or PSA increase ≥0.2 g, followup 6 monthsMultiple percutaneous cryoprobes were placed to ablate the entire prostate with real-time transrectal ultrasound monitoringProgression free survival89%
Case seriesPositive biopsy11%
Sosa, 1996 33 1,467 patients with prostate cancer, 5% with Gleason score >8Multiple percutaneous cryoprobes were placed to ablate the entire prostate with real-time transrectal ultrasound monitoringUrethrorectal fistula1.4%
Multicenter case seriesTissue sloughing9.9%
Urethral stricture5%
Bladder outlet obstruction6.8%
Incontinence11%
Impotence100%
Perineal pain9.4%
Urinary tract infection9.1%
Sepsis2.3%
Wake, 1996 34 104 patients with localized adenocarcinoma of the prostate, 46% with T >2, mean PSA ng/ml 11.3, 14% Gleason ≥7, followup 6 months, treatment failure: PSA >4 ng/ml positive biopsyMultiple percutaneous cryoprobes (5) were placed under ultrasound guidance. Average hospital stay 36.6 hoursProgression free survival96%
Noncontrolled clinical trialPositive biopsy25%
Mean PSA ng/ml1.15
Tissue sloughing1%
Urethral stricture1.9%
Bladder outlet obstruction21.2%
Incontinence7.7%
Perineal pain9.6%
Wieder, 1995 35 83 patients with prostate cancer, mean age 67 years, 22.9% with T >2, mean PSA ng/ml 6.5–9.6Transrectal ultrasound-guided transperineal percutaneous cryoablation with an Accuprobe System cryosurgery instrument (3 to 6 probes)Progression free survival92.6%
Case seriesPositive biopsy19.3%
Mean PSA ng/ml3.5
Urethrorectal fistula0%
Tissue sloughing3.8%
Urethral stricture2.2%
BOO3%
Incontinence4%
Perineal pain0.4%
Urinary tract infection2.2%
Epididymitis1.6%
Sepsis0.7%
Urethral obstruction2%
Robinson, 1999, 2002 36, 37 75 patients with localized prostate cancer, 11–12% with T 1–2, the Functional Assessment of Cancer Treatment-ProstateTransrectal ultrasound-guided percutaneous radical cryosurgical ablation with multiple probes and transrectal ultrasound guidanceScores (SE) (max 28)
Phase 2 of noncontrolled clinical trialPhysical well-being26.01 (2.93)
Social/family well-being23.46 (4.62)
Emotional well-being17.92 (2.87)
Functional well-being24.34 (3.95)
Relationship with doctor7.40 (1.54) max 8

From: Appendix C, Evidence Tables and Figures

Cover of Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer
Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer [Internet].
Comparative Effectiveness Reviews, No. 13.
Wilt TJ, Shamliyan T, Taylor B, et al.

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