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

Bahn, Duke; Lee, Fred; Badalament, Robert A.; Kumar, Anil; Greski, Jeffrey; Chernick, Michael R.

doi:10.1016/s0090-4295(02)01678-3

Cited by 293 publications

(194 citation statements)

References 40 publications

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“…12,22 CRYO outcomes are similarly unclear and have been reported many ways, including threshold criteria and the first ASTRO definition. [7][8][9] Currently, there is no universally agreed upon definition of …”

Section: Discussionmentioning

confidence: 99%

“…The clinical importance of this finding is unknown; although a positive biopsy after CRYO is considered indicative of local failure, 8 its association with long-term outcome is not known. Similarly, the clinical importance of positive biopsies after EBRT is unknown.…”

Section: Gastrointestinalmentioning

confidence: 99%

“…7,8 We previously reported a phase 2 CRYO series with 5-year probabilities of maintaining a prostate-specific antigen (PSA) level 1.0 ng/mL for low-risk, intermediate-risk, and high-risk patients of 75%, 89%, and 76%, respectively. 9 Herein, we present the results of our singleinstitution, randomized trial in which we compared EBRT with CRYO for clinically localized prostate cancer at the Tom Baker Cancer Center.…”

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confidence: 99%

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A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer

Donnelly

Saliken

Brasher

et al. 2009

Cancer

138

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BACKGROUND: Localized prostate cancer can be treated several different ways, but head-to-head comparisons of treatments are infrequent. The authors of this report conducted a randomized, unblinded, noninferiority trial to compare cryoablation with external beam radiotherapy in these patients. METHODS: From December 1997 through February 2003, 244 men with newly diagnosed localized prostate cancer were assigned randomly to receive either cryoablation or radiotherapy (122 men in each arm). All received neoadjuvant antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a trifecta definition: 1) radiologic evidence of metastatic disease, or 2) initiation of further antineoplastic therapy, or 3) biochemical failure. Two definitions of biochemical failure were used: 1) 2 consecutive rises in prostate-specific antigen (PSA) with a final value >1.0 ng/mL, and 2) a rise above PSA nadir þ 2 ng/mL. Secondary endpoints included overall survival, disease-specific survival, and prostate biopsy at 36 months. RESULTS: The median follow-up was 100 months. Disease progression at 36 months was observed in 23.9% (PSA nadir þ 2 ng/mL, 17.1%) of men in the cryoablation arm and in 23.7% (PSA nadir þ 2 ng/mL, 13.2%) of men in the radiotherapy arm. No difference in overall or disease-specific survival were observed. At 36 months, more patients in the radiotherapy arm had a cancer-positive biopsy (28.9%) compared with patients in the cryoablation arm (7.7%). CONCLUSIONS: The observed difference in disease progression at 36 months was small, 0.2%; however, because of the wide confidence interval, from À10.8% to 11.2%, it was not possible to rule out inferiority (defined a priori as a 10% difference). With longer term follow-up, the trend favors cryoablation. Significantly fewer positive biopsies were documented after cryoablation than after radiotherapy. Cancer 2010;116:323-30.

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Section: Discussionmentioning

confidence: 99%

Section: Gastrointestinalmentioning

confidence: 99%

mentioning

confidence: 99%

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A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer

Donnelly

Saliken

Brasher

et al. 2009

Cancer

138

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“…Published series have defined biochemical recurrence after cryotherapy as an increase in PSA of X0.2 ng ml -1 over the nadir 22 or a level of 0.5 ng ml -1 or 1.0 ng ml -1 . 23 The American Society of Therapeutic Radiology and Oncology ASTRO guidelines have also been used to define failure after cryotherapy, that is three consecutive rises in PSA after the PSA nadir has been reached. 24 In addition, a positive biopsy is required.…”

Section: Discussionmentioning

confidence: 99%

Cryoablation of the prostate: technical recommendations

Cytron

Greene

Witzsch

et al. 2009

Prostate Cancer Prostatic Dis

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The European Association of Urology guidelines on prostate cancer state that cryotherapy is a true therapeutic alternative for patients with clinically localized prostate cancer. The aim of this paper is to establish a uniform practice for performing prostate cryoablation. A collaboration has been set up among five European centres with experience in almost 1000 prostate cancer patients on the use of cryotherapy. The present recommendations were developed through sharing of experience and thorough discussions within the group. This first paper from the group establishes the technical recommendations for use of prostate cryotherapy.

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“…Several other nonrandomized series on CRYO for 'all comers' suggested a 'role for CRYO in the management of localized prostate cancer'. [18][19][20][21] These series typically included 12-20% patients with higher-staged tumors (T2B-T4), although the data on more locally extensive cancers were difficult to interpret as some parameters were not controlled. These include the presence or absence or length of hormone therapy, subjective designation of local 'T staging', separate reporting on results for various 'risk categories' rather than 'stages' and combined reporting on both primary and salvage cases.…”

Section: Discussionmentioning

confidence: 99%

Randomized trial comparing cryoablation and external beam radiotherapy for T2C-T3B prostate cancer

Chin

Touma

et al. 2007

Prostate Cancer Prostatic Dis

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The objective was to evaluate the relative efficacy of cryoablation (CRYO) versus external beam radiation (EBRT) for clinically locally advanced prostate cancer in a randomized clinical trial. Patients with histologically proven, clinically staged as T2C, T3A or T3B disease were randomized with 6 months of perioperative hormone therapy to one of the two procedures. Owing largely to a shift in practice to longer term adjuvant hormonal therapy and higher doses of radiation for T3 disease, only 64 out of the planned 150 patients were accrued. Twenty-one of 33 (64%) in the CRYO group and 14 of 31 (45%) in the EBRT-treated group who had met the ASTRO definition of failure were also classified as treatment failure. The mean biochemical disease-free survival (bDFS) was 41 months for the EBRT group compared to 28 months for the CRYO group. The 4-year bDFS for EBRT and CRYO groups were 47 and 13%, respectively. Disease-specific survival (DSS) and overall survival (OS) for both groups were very similar. Serious complications were uncommon in either group. EBRT patients exhibited gastrointestinal (GI) adverse effects more frequently. Taking into account the relative deficiency in numbers and the original trial design, this prospective randomized trial indicated that the results of CRYO were less favorable compared to those of EBRT, and was suboptimal primary therapy in locally advanced prostate cancer.

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

Cited by 293 publications

References 40 publications

A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer

A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer

Cryoablation of the prostate: technical recommendations

Randomized trial comparing cryoablation and external beam radiotherapy for T2C-T3B prostate cancer

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