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

Chin, Joseph L.; Ng, Chee Kwan; Touma, Naju; Pus, Nancy; Hardie, R; Abdelhady, Mazen; Rodrigues, George; Radwan, John S.; Venkatesan, Varagur; Moussa, Madeleine; Downey, Dónal B.; Bauman, Glenn

doi:10.1038/sj.pcan.4500988

Cited by 50 publications

(27 citation statements)

References 17 publications

(23 reference statements)

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“…Chin et al 18 reported a lower biochemical disease-free survival rate at 4 years in CRYO-treated patients than in EBRT-treated patients (13% versus 47%). However, their trial was limited to patients with locally advanced disease and, thus, is not comparable to our trial, which explicitly excluded that patient population.…”

Section: Discussionmentioning

confidence: 98%

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: 98%

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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“…Targeted cryoablation of the prostate (TCAP) has emerged as an accepted therapy for both primary treatment of clinically localized CaP, as well as for salvage therapy following failed definitive therapy, demonstrating survival and cancer-control at least equivocal to external-beam radiotherapy (3)(4)(5)(6)(7). Erectile dysfunction (ED) and voiding dysfunction are common following all potentially curative CaP treatments.…”

Section: Introductionmentioning

confidence: 99%

Contemporary analysis of erectile, voiding, and oncologic outcomes following primary targeted cryoablation of the prostate for clinically localized prostate cancer

et al. 2008

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Purpose: To evaluate erectile function (EF) and voiding function following primary targeted cryoablation of the prostate (TCAP) for clinically localized prostate cancer (CaP) in a contemporary cohort. Materials and Methods:We retrospectively reviewed all patients treated between 2/2000-5/2006 with primary TCAP. Variables included age, Gleason sum, pre-TCAP prostate specific antigen (PSA), prostate volume, clinical stage, pre-TCAP hormonal ablation, pre-TCAP EF and American Urologic Association Symptom Score (AUASS). EF was recorded as follows: 1 = potent; 2 = sufficient for intercourse; 3 = partial/insufficient; 4 = minimal/insufficient; 5 = none. Voiding function was analyzed by comparing pre/post-TCAP AUASS. Statistical analysis utilized SAS software with p < 0.05 considered significant. Results: After exclusions, 78 consecutive patients were analyzed with a mean age of 69.2 years and follow-up 39.8 months. Thirty-five (44.9%) men reported pre-TCAP EF level of 1-2. Post-TCAP, 9 of 35 (25.7%) regained EF of level 1-2 while 1 (2.9%) achieved level 3 EF. Median pre-TCAP AUASS was 8.75 versus 7.50 postoperatively (p = 0.39). Six patients (7.7%) experienced post-TCAP urinary incontinence. Lower pre-TCAP PSA (p = 0.008) and higher Gleason sum (p = 0.002) were associated with higher post-TCAP AUASS while prostate volume demonstrated a trend (p = 0.07). Post-TCAP EF and stable AUASS were not associated with increased disease-recurrence (p = 0.24 and p = 0.67, respectively). Conclusions: Stable voiding function was observed post-TCAP, with an overall incontinence rate of 7.7%. Further, though erectile dysfunction is common following TCAP, 25.7% of previously potent patients demonstrated erections suitable for intercourse. While long-term data is requisite, consideration should be made for prospective evaluation of penile rehabilitation following primary TCAP.

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“…Significantly fewer positive biopsies were documented after cryoablation than after radiation therapy (7.7% vs. 28.9%). For localized and locally advanced disease (T2c-T3b) with a mean follow-up of 37 months, Chin et al [11] compared 33 patients who underwent cryoablation and 31 patients who received radiotherapy. All patients received three months of neoadjuvant and three months of adjuvant ADT using GnRH agonist monotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…Cryosurgical ablation of the prostate with shortterm ADT for 3-6 months had been utilized in several series, mainly for the purpose of comparison with radiotherapy [10][11][12]. However, in terms of ADT in a combination strategy, the method and duration has not been clearly established.…”

Section: Introductionmentioning

confidence: 99%

The biochemical efficacy of primary cryoablation combined with prolonged total androgen suppression compared with radiotherapy on high-risk prostate cancer: a 3-year pilot study

Kang²,

Park³

et al. 2010

Asian J Androl

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To gain beneficial effects in the management of high-risk prostate cancer, an integrated approach that combines local therapy and androgen deprivation therapy (ADT) was used. We compared biochemical responses between primary cryosurgical ablation of the prostate (CSAP) combined with prolonged ADT and radiation combined with ADT, which is the established modality in high-risk disease. A total of 33 high-risk patients received CSAP combined with ADT for 3 months before and up to 24 months after treatment. This patient group was matched with another 33 patients who had undergone three-dimensional conformal radiation therapy (3D-CRT) with the same protocol for ADT. Biochemical recurrence (BCR) was assessed by the American Society for Therapeutic Radiation Oncology (ASTRO) definition, the Phoenix definition and a prostate-specific antigen (PSA) cutoff of 0.5 ng mL −1 . Median follow-up was 61.0 ± 11.9 months for the CSAP + ADT group and 86.0 ± 15.8 months for the 3D-CRT + ADT group. In the CSAP group, major complications including rectourethral fistula and incontinence were not noted. In the CSAP + ADT group, 57.0% had BCR using the ASTRO definition, 21.2% using the Phoenix definition and 54.5% using a PSA cutoff of 0.5 ng mL −1 . In the 3D-CRT + ADT group, 54.5%, 21.2% and 54.5% had BCR using the ASTRO, Phoenix and PSA definition, respectively. In the CSAP + ADT group, the BCR-free survival (BRFS) was 54 ± 10 months using the ASTRO definition, 65 ± 5 months using the Phoenix definition and 51 ± 4 months using a PSA cutoff of 0.5 ng mL −1 . In the 3D-CRT + ADT group, the BRFS was 68 ± 12, 93 ± 19 and 70 ± 18 months using the ASTRO, Phoenix and PSA definition, respectively. By the log-rank test, the BRFS values for each group were not statistically different. This intermediate-term result indicated that primary CSAP combined with prolonged ADT offers a parallel biochemical response compared with radiotherapy in high-risk prostate cancer.

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

Cited by 50 publications

References 17 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

Contemporary analysis of erectile, voiding, and oncologic outcomes following primary targeted cryoablation of the prostate for clinically localized prostate cancer

The biochemical efficacy of primary cryoablation combined with prolonged total androgen suppression compared with radiotherapy on high-risk prostate cancer: a 3-year pilot study

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