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1.
Pinthus JH Farrokhyar F Hassouna MM Woods E Whelan K Shayegan B Orovan WL 《BJU international》2012,110(8):1142-1148
Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? The experience with HIFU as a minimally invasive treatment for localized prostate cancer is relatively new and most reports are from European centres. Our study is unique in five regards: 1. Data was collected prospectively. 2. All patients were treated with contemporary technology. 3. Outcomes are reported after a single HIFU session using two definitions of biochemical failure that have the ability to predict longer‐term clinical failure after primary ablative therapies for prostate cancer (Stuttgart definition for HIFU and Horwitz definition for radiation). 4. All patients were treated in a single centre. 5. No patients underwent peri‐HIFU TURP. The present study represents the largest North American prospective cohort of primary HIFU for prostate cancer with mid‐term oncological outcome data.
OBJECTIVE
- ? To assess 4‐year biochemical failure (BCF) rates in patients after high‐intensity focused ultrasonography (HIFU) treatment using the Horwitz and Stuttgart definitions.
PATIENTS AND METHODS
- ? A total of 447 consecutive patients were treated with a single session of HIFU between May 2005 and December 2010.
- ? Follow‐up included prostate‐specific antigen (PSA) measurement every 3 months during the first year and every 6 months thereafter.
- ? Patients who had previously received radiation, androgen deprivation or HIFU therapy, and patients with <2 consecutive PSA measurements were excluded.
- ? BCF was reported using the Stuttgart (PSA nadir + 1.2 ng/mL rising) and the Horwitz (two consecutive increases of at least 0.5 ng/mL) definitions.
RESULTS
- ? In all, 402 patients met the inclusion criteria and the median (range) follow‐up was 24 (6–48) months.
- ? Of these patients, 183 (45.5%) had low and 219 (54.5%) had intermediate D'Amico's risk stratification disease.
- ? Mean and median absolute PSA nadir levels were 0.36 ± 0.69 and 0.1 ng/mL (Q1:0, Q3:0.37), respectively and these were achieved in median time of 3 months.
- ? Overall 4‐year mean (range) BCF‐free rates were 68 (61–75)% and 72 (68–77)% according to the Stuttgart and Horwitz definitions at 4 years, respectively.
- ? Mean (range) BCF‐free rates were significantly higher for a PSA nadir ≤0.5 ng/mL and prostate volume ≤30 mL for both definitions at 4‐year follow‐up [Stuttgart: 79 (72–86)% vs. 25 (13–38)%; Horwitz: 82 (77–87)% vs. 33 (21–44)%] and [Stuttgart: 72 (64–79)% vs. 56 (42–69)%; Horwitz: 75 (69–80)% vs. 63 (53–74)%], respectively.
- ? Pre‐treatment PSA and PSA nadir of >0.5 ng/mL were the predictors of BCF using both definitions.
CONCLUSIONS
- ? Primary HIFU appears to result in promising 4‐year BCF‐free rates in individuals with low‐ and intermediate‐risk prostate cancer who achieve PSA nadir <0.5 ng/mL.
- ? A prostate volume <30 mL is associated with PSA nadir levels of <0.5 ng/mL suggesting a potential role for pretreatment volume reduction (medically or surgically) in larger prostates.
2.
Benjamin J. Challacombe Declan G. Murphy Rhana Zakri Declan J. Cahill 《BJU international》2009,104(2):200-204
OBJECTIVE
To report on the short‐term functional and oncological results, from one institution, of high‐intensity focused ultrasound (HIFU) for treating localized prostate cancer.PATIENTS AND METHODS
Over a 3‐year period, 43 patients with localized prostate cancer were scheduled for HIFU in the primary (31) and salvage (12) settings using a second‐generation AblathermTM device (EDAP, Lyon, France). Oncological failure was defined by several criteria, including biochemical failure (assessed using both the Phoenix definition of the nadir + 2 ng/mL) and the current Food and Drug Administration (FDA) trial endpoint of a prostate‐specific antigen (PSA) level of ≥0.5 ng/mL, or starting salvage therapy, or the presence of cancer on biopsy after treatment.RESULTS
Three patients had their procedures abandoned due to technical limitations/rectal wall thickness. The mean PSA levels in the primary and salvage groups were 9.2 and 5.1 ng/mL, respectively. The mean HIFU treatment time in the primary and salvage groups was 71.1 and 63.3 min, respectively. Using the Phoenix definition of biochemical failure, HIFU treatment failed in 13 patients in the primary group (46%) and five in the salvage group. Using the FDA trial endpoint, HIFU failed in 21 patients in the primary group (75%) and eight in the salvage group. One man died from metastatic prostate cancer 18 months after salvage HIFU. There were two urethral strictures in the primary (7%) and one in the salvage treatment group. There were two prostato‐rectal fistulae in the salvage HIFU group.CONCLUSIONS
HIFU is proposed to be a minimally invasive low‐morbidity ablative treatment for localized prostate cancer, and with good efficacy. The present limited series is unable to support these claims. There were significant rates of complications and oncological failure in both the primary and salvage setting. As a result we have suspended our programme pending further evidence of its safety and efficacy. 相似文献3.
Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? High‐intensity focused ultrasound (HIFU) therapy has been proposed for the treatment of localized prostate cancer (PCa) for all risk levels of tumour recurrence. The study adds data on the efficacy of a single HIFU application in the treatment of PCa with different risks of recurrence. Durable cancer control was achieved in 81.7% of patients with low‐risk disease, with rates of efficacy declining in intermediate‐ and high‐risk tumours. The data suggest that the principal domain for minimal invasive HIFU should be low‐risk disease.
OBJECTIVE
- ? To report cancer control results after a single application of high‐intensity focused ultrasonography (HIFU) in patients with localized prostate cancer (PCa), stratified by tumour recurrence risk according to D'Amico risk classification.
PATIENTS AND METHODS
- ? In a retrospective single‐centre study, we analysed the outcomes of patients with localized PCa who were treated with curative intent between December 2002 and October 2006 using an Ablatherm HIFU device (EDAP‐TMS, France).
- ? Transurethral resection of the prostate or adenomectomy were performed before HIFU to downsize large prostate glands.
- ? Oncological failure was determined by the occurrence of biochemical relapse, positive biopsy and/or metastasis. Biochemical relapse was defined as a PSA nadir +1.2 ng/mL (Stuttgart definition), or as a rise in PSA level to ≥0.5 ng/mL if PSA doubling time was ≤6 months. Kaplan–Meier analysis was performed for survival estimates.
RESULTS
- ? A total of 191 consecutive patients were included in the study. The median (range) patient age was 69.7 (51–82) years, and 38, 34 and 28% of these patients were in the low‐, intermediate‐ and high‐risk groups, respectively.
- ? The median (range) follow‐up was 52.8 (0.2–79.8) months.
- ? At 5 years, overall and cancer‐specific survival rates were 86.3% and 98.4%, respectively.
- ? Stratified by risk group, negative biopsy rates were 84.2%, 63.6%, and 67.5% (P = 0.032), 5‐year biochemical‐free survival rates were 84.8%, 64.9% and 54.9% (P < 0.01), and 5‐year disease‐free survival rates were 81.7%, 53.2% and 51.2% (P < 0.01), respectively.
CONCLUSION
- ? Single‐session HIFU is recommended as a curative approach in elderly patients with low‐risk PCa. Patients at higher risk of tumour progression should be counselled regarding the likely need for salvage therapy, including repeat HIFU.
4.
Kazumasa Komura Teruo Inamoto Tomoaki Takai Taizo Uchimoto Kenkichi Saito Naoki Tanda Junko Kono Koichiro Minami Hirohumi Uehara Yutaka Fujisue Kiyoshi Takahara Hajime Hirano Hayahito Nomi Toshikazu Watsuji Satoshi Kiyama Haruhito Azuma 《World journal of urology》2014,32(5):1339-1345
Purpose
To investigate the treatment outcomes of a single-session high-intensity focused ultrasound (HIFU) using the Sonablate® for patients with localized prostate cancer.Methods
Biochemical failure was defined according to the Stuttgart definition [a rise of 1.2 ng/ml or more above the nadir prostate-specific antigen (PSA)] and the Phoenix definition (a rise of 2 ng/ml or more above the nadir PSA). Disease-free survival rate was defined using the Phoenix criteria and positive follow-up biopsy.Results
A total of 171 patients were identified. Fifty-two (30.4 %) patients were identified to be with D’Amico low risk, 47 (27.5 %) with intermediate risk, and 72 (42.1 %) with high risk. In the median follow-up time of 43 months, there was 44 (25.7 %) and 36 (21.1 %) patients experienced biochemical failure for Stuttgart and Phoenix definition with mean (±SD) time to failure of 17.8 ± 2.1 and 19.4 ± 2.3 months, respectively. A total of 44 (25.7 %) patients were diagnosed as disease failure. Cox multivariate analysis revealed PSA nadir level (PSA cutoff = 0.2 ng/ml; HR = 9.472, 95 % CI 4.527–19.820, p < 0.001) and D’amico risk groups [HR = 3.132 (95 % CI 1.251–6.389), p = 0.033] were the predictor for failure in single-session HIFU.Conclusions
Single-session HIFU treatment using the Sonablate® seems to be potentially curative approach. When treated carefully with neoadjuvant hormonal therapy or preoperative transurethral resection of the prostate, higher-risk disease might be able to choose this minimally invasive procedure as primary therapy. 相似文献5.
Study Type – Therapy (case series)Level of Evidence 4 What’s known on the subject? and What does the study add? Salvage HIFU is a promising treatment option for local recurrence after radiation therapy, with morbidity comparable with other forms of salvage treatment. This study showed a long‐term follow up of salvage HIFU in men with recurrence of localized prostate cancer following not only external beam radiation therapy but also brachytherapy or proton therapy.
OBJECTIVE
To investigate the use of high‐intensity focused ultrasound (HIFU) as a salvage therapy in patients with recurrence of localized prostate cancer after external beam radiation (EBRT), brachytherapy, or proton therapy.PATIENTS AND METHODS
We retrospectively reviewed the charts of all patients who had undergone salvage HIFU for biopsy‐proven prostate cancer after primary radiation therapy. Patient characteristics and oncological outcomes were assessed.RESULTS
Records of 22 patients with a median (range) follow‐up of 24 (5–80) months were reviewed. Patients were men with presumed organ‐confined disease who had been treated with salvage HIFU following recurrent disease after EBRT (fourteen patients), brachytherapy (five patients: four with high‐dose brachytherapy using In192; and one with low‐dose brachytherapy using Au98) or proton therapy (three patients). The median (range) age at salvage HIFU was 65 (52–80) years, with a median (range) prostate‐specific antigen (PSA) level before radiation therapy of 14.3 (5.7–118) ng/mL and a median (range) PSA level of 4.0 (1.2–30.1) ng/mL before HIFU. The median (range) period to HIFU after radiation therapy was 36 (4–96) months. The biochemical disease‐free survival (bDFS) rate in all patients at 5 years was 52%. Rates of bDFS in low‐, intermediate‐ and high‐risk groups were 100%, 86%, and 14%, respectively. One of the twelve patients who received post‐HIFU prostate biopsy showed malignancy. Side effects included urethral stricture in four patients, grade I urinary incontinence in four patients, rectourethral fistula and epididymitis in one of each patient.CONCLUSION
Salvage HIFU is a promising treatment option for local recurrence after radiation therapy, with morbidity comparable with other forms of salvage treatment. 相似文献6.
Gontero P Spahn M Tombal B Bader P Hsu CY Marchioro G Frea B Van Der Eeckt K Kneitz B Frohneberg D Tizzani A Van Poppel H Joniau S 《BJU international》2011,108(7):1093-1100
Study Type – Prognosis (retrospective cohort) Level of Evidence 2b
OBJECTIVE
? To assess the feasibility of radical prostatectomy (RP) in a series of patients with prostate cancer with very high prostate‐specific antigen (PSA) levels by comparing the clinical outcomes of different PSA thresholds (20.1–50 ng/mL, 50.1–100 ng/mL and >100 ng/mL, respectively).PATIENTS AND METHODS
? Within a multicentre European retrospective database of 712 RP in patients with a baseline PSA level >20 ng/mL, we identified 48 patients with prostate cancer with a preoperative PSA level >100 ng/mL, 137 with a PSA level between 50.1 and 100 ng/mL and 527 with PSA values between 20.1 and 50 ng/mL. ? Comparisons between groups were performed using chi‐square test, analysis of variance and Kaplan–Meier analysis with log‐rank test.RESULTS
? Ten‐year projected cancer‐specific survival (79.8% in the PSA >100 ng/mL group vs 85.4% in the PSA 50.1–99 ng/mL group vs 90.9% in the PSA 20.1–50 ng/mL interval; P= 0.037) but not overall survival (59.6% in the PSA >100 ng/mL group vs 71.8% in the PSA 50.1–99 ng/mL group vs 75.3% in the PSA 20.1–50 ng/mL interval; P= 0.087) appeared significantly affected by the different PSA thresholds. ? At a median follow‐up of 78.7 months, 25.8%, 6.6% and 8.3% of patients in the PSA level groups for 20.1–50 ng/mL, 50.1–100 ng/mL and >100 ng/mL respectively, were cured by surgery alone.CONCLUSIONS
? Ten‐year cancer‐specific survival, while showing significant reduction with increasing PSA values intervals, remain relatively high even for PSA levels >100 ng/mL. ? As part of a multimodal treatment strategy, RP may therefore be an option, even in selected patients with prostate cancer whose PSA level is >100 ng/mL. 相似文献7.
Misraï V Rouprêt M Chartier-Kastler E Comperat E Renard-Penna R Haertig A Bitker MO Richard F Conort P 《World journal of urology》2008,26(5):481-485
Objective
To assess the long term oncologic results of high-intensity focused ultrasound therapy (HIFU) as a primary and single treatment for clinically localized prostate cancer.Methods
A total of 119 patients with clinically localized prostate cancer underwent HIFU (Ablatherm®, EDAP, France) as first-line treatment and were retrospectively reviewed. They were stratified according to risk groups proposed by D’Amico. No patient had undergone previous hormonal therapy. PSA level was monitored at 3, 6, 12, 18, 24 months and then yearly. According to the latest ASTRO criteria, failure was defined by a PSA rise of 2 ng/ml or more above the PSA nadir. The biochemical-free survival rate (BFSR) was calculated.Results
Mean patient age was 68 ± 7.8 years (46–83). Mean follow-up was 3.9 years (1–6.8). Overall 52 patients (43.7%) experienced a biochemical recurrence which included 26, 23 and 3 patients in the low, intermediate and high-risk groups, respectively. In univariate and multivariate analyses, there was a statistical association between preoperative PSA value > 10, a nadir PSA value > 1 and the risk of biochemical recurrence (P < 0.05). The 5-year BFSR rate was 30% with no statistical difference between low- and intermediate-risk patients. None of the 119 patients died of prostate cancer.Conclusion
High-intensity focused ultrasound therapy provides efficient oncologic control only in patients with low-risk prostate cancer. However, our data could be used to improve the selection of patients who are potential candidates for HIFU therapy.8.
Zacharakis E Ahmed HU Ishaq A Scott R Illing R Freeman A Allen C Emberton M 《BJU international》2008,102(7):786-792
OBJECTIVES
To investigate the use of minimally invasive high‐intensity focused ultrasound (HIFU) as a salvage therapy in men with localized prostate cancer recurrence following external beam radiotherapy (EBRT).PATIENTS AND METHODS
A review of 31 cases treated using the Sonablate® 500 HIFU device, between 1 February 2005 and 15 May 2007, was carried out. All men had presumed organ‐confined, histologically confirmed recurrent prostate adenocarcinoma following EBRT.RESULTS
The mean (range) age was 65 (57–80) years with a mean preoperative PSA level of 7.73 (0.20–20) ng/mL. The patients were followed for a mean (range) of 7.4 (3–24) months. Side‐effects included stricture or intervention for necrotic tissue in 11 of the 31 patients (36%), urinary tract infection or dysuria syndrome in eight (26%), and urinary incontinence in two (7%). Recto‐urethral fistula occurred in two men, although one was due to patient movement due to inadequate anaesthesia, so the ‘true’ rate is 3%. Half of the patients had PSA levels of <0.2 ng/mL at the last follow‐up. Three patients had metastatic disease whilst another two had only local, histologically confirmed, failure. A further four patients had evidence of biochemical failure only. Overall, 71% had no evidence of disease following salvage HIFU.CONCLUSIONS
Salvage HIFU is a minimally invasive daycase procedure that can achieve low PSA nadirs and good cancer control in the short term, with comparable morbidity to other forms of salvage treatment. The issue of accurate staging at the time of recurrence is still problematic, as a proportion of these men will harbour microscopic metastases undetected by conventional staging investigations. 相似文献9.
Study Type – Aetiology (individual cohort) Level of Evidence 2b What’s known on the subject? and What does the study add? The precise relationship between serum testosterone (T) and prostate cancer (PCa) incidence and progression is controversial. Low pre‐treatment serum T correlates with higher risk of BF after radical prostatectomy, and T may possess biological information about PCa progression potential.
OBJECTIVE
? To investigate serum testosterone levels as a predictor for biochemical failure (BF) after radical retropubic prostatectomy (RRP).PATIENTS AND METHODS
? Prospective cohort study with 227 patients and a median follow‐up of 7.7 years. ? Total serum testosterone was measured at diagnosis. ? Primary endpoint: 5‐year BF‐free survival defined as first PSA > 0.2 ng/mL. ? Testosterone was tested as a predictor of BF as a dichotomized and continuous variable.RESULTS
? Median (range) age was 62 years (45–74), median PSA 9.9 ng/mL (0.4–96), and median testosterone was 14 nmol/L (2.2–40). ? BF occurred for 57 patients (26%) within 5 years. ? In multivariate analysis with age, PSA, and biopsy Gleason score, testosterone levels >11 nmol/L were an independent predictor for reduced risk of BF (hazard ratio, 0.53; 95% confidence interval, 0.31–0.90; P= 0.02). ? When analyzed as a continuous variable, testosterone was not a statistically significant predictor of BF.CONCLUSION
? Low pretreatment serum testosterone levels correlate with a higher risk of BF, and testosterone may possess biological information about prostate cancer progression potential, which makes it an independent predictor of biochemical failure after RRP. 相似文献10.
Akiko Murota‐Kawano Mayura Nakano Sachiko Hongo Sunao Shoji Yoshihiro Nagata Toyoaki Uchida 《BJU international》2010,105(12):1642-1645
Study Type – Therapy (case series) Level of Evidence 4
OBJECTIVE
To present experience in high‐intensity focused ultrasound (HIFU) used as a salvage therapy for biopsy‐confirmed local recurrence at the vesico‐urethral anastomosis after radical prostatectomy (RP).PATIENTS AND METHODS
From July 2006, four patients diagnosed with prostate cancer recurrence after RP were treated with HIFU, with or without salvage radiotherapy, using the Sonablate® 500 (Focus Surgery, IN, USA). Biochemical failure was defined as in increase in prostate‐specific antigen (PSA) level of >0.2 ng/mL. No patients received any adjuvant therapy after HIFU therapy before reporting failure.RESULTS
The mean age and initial PSA level before RP was 74 years and 10.0 ng/mL, respectively. After RP, one patient was stage T2aN0M0, two were stage T3N0M0 and the last had an unknown pathological stage. Three patients received external beam radiotherapy as salvage therapy after RP. The mean PSA level before HIFU, tumour volume at the vesico‐urethral lesion and operative duration were 4.3 ng/mL, 4.6 mL and 27 min, respectively. Adenocarcinomas were confirmed by biopsy of the tumour at the vesico‐urethral anastomotic lesion before HIFU. At 24 months of follow‐up, patients 2 and 4 were classified a biochemically disease‐free. Biopsies at the anastomotic site after HIFU in three patients showed no malignancy, with fibrosis. There were no complications.CONCLUSION
Salvage HIFU for patients with recurrence after RP is feasible, even though they received salvage radiotherapy before HIFU. More patients and a longer follow‐up are needed to evaluate the safety and oncological adequacy of this new approach. 相似文献11.
OBJECTIVE: To evaluate the biochemical disease-free survival (DFS), predictors of clinical outcome and morbidity of patients with localized prostate cancer treated with high-intensity focused ultrasound (HIFU), a noninvasive treatment that induces complete coagulative necrosis of a tumour at depth through the intact skin. PATIENTS AND METHODS: In all, 63 patients with stage T1c-2bN0M0 localized prostate cancer underwent HIFU using the Sonablate system (Focus Surgery, Inc., Indianapolis, IN, USA). None of the patients received neoadjuvant and/or adjuvant therapy. Biochemical recurrence was defined according to the criteria recommended by the American Society for Therapeutic Radiology and Oncology consensus definition, i.e. three consecutive increases in prostate-specific antigen (PSA) level after the nadir. The median (range) age, PSA level and follow-up were 71 (45-87) years, 8.5 (3.39-57.0) ng/mL and 22.0 (3-63) months, respectively. RESULTS: The overall biochemical disease-free rate was 75% (47 patients). The 3-year biochemical DFS rates for patients with a PSA level before HIFU of <10, 10.01-20 and >20 ng/mL were 82%, 62% and 20% (P < 0.001), respectively. The 3-year biochemical DFS rates for patients with a PSA nadir of <0.2, 0.21-1 and >1 ng/mL were 100%, 74% and 21% (P < 0.001), respectively. Final follow-up sextant biopsies showed that 55 (87%) of the patients were cancer-free. Multivariate analysis showed that the PSA nadir (P < 0.001) was a significant independent predictor of relapse. CONCLUSION: HIFU therapy appears to be a safe, effective and minimally invasive therapy for patients with localized prostate cancer, and the PSA nadir is a useful predictor of clinical outcome. 相似文献
12.
Yoji Inoue Keisuke Goto Tetsutaro Hayashi Mutsuo Hayashi 《International journal of urology》2011,18(5):358-363
Objectives: To assess the long‐term outcomes of transrectal high‐intensity focused ultrasound (HIFU) for patients with localized prostate cancer. Methods: From May 2003 to present, 137 consecutive patients with T1‐2 prostate cancer were treated using the Sonablate 500 and then followed for more than 12 months after their last HIFU treatment. A prostate biopsy was routinely carried out at 6 months and serum prostate‐specific antigen (PSA) was measured every 3 months after HIFU. Oncological outcomes as well as treatment‐related complications were assessed. Disease‐free survival (DFS) was judged using the Phoenix definition (PSA nadir + 2 ng/mL), negative histological findings and no local or distant metastasis. Results: The median follow up after HIFU was 36 months (range 12–84 months). No patients received adjuvant therapy during this period. The PSA nadir occurred at 2 months after HIFU and the median level was 0.07 ng/mL (0.01–2.01 ng/mL). Of the 133 patients who underwent prostate biopsy or transurethral resection of the prostate at 6 months or later after HIFU, six were positive for cancer cells (4.5%). There were no major postoperative complications, but urge incontinence (16 cases) and dysuria (33 cases) occurred after removal of the urethral catheter. The 5‐year DFS rate was 78% based on these criteria, and 91%, 81% and 62% in the low‐, intermediate‐ and high‐risk group, respectively. Conclusions: HIFU represents an effective, repeatable and minimally invasive treatment. It is particularly effective for low‐ and intermediate‐risk patients, and it should be considered as an option for localized prostate cancer. 相似文献
13.
Crawford ED Moul JW Rove KO Pettaway CA Lamerato LE Hughes A 《BJU international》2011,108(11):1743-1749
Study Type – Prognosis (inception cohort) Level of Evidence 1b What’s known on the subject? and What does the study add? Large population screening trials like the ERSPC, PCPT and PLCO have noted that men with seemingly low PSA (even as low as 0.5 ng/dL) still can have prostate cancer. Despite these findings, PSA is still predominantly used as a current indicator for possible presence of prostate cancer rather than also serving as a prognostic marker. This study examines a larger number of men in a diverse US population to determine the prognostic value of a man’s baseline or first PSA.
OBJECTIVES
? To assess the value of a PSA threshold of 1.5 ng/mL as a predictor of increased prostate cancer risk over a four‐year period based on a man’s first PSA test, including racial differences. ? To review the risk of progression of benign prostatic hyperplasia (BPH) based on a similar PSA threshold.PATIENTS AND METHODS
? A retrospective review involving 21 502 men from a large Midwestern health system was performed. ? Men at least 40 years old with baseline PSA values between 0 and 4.0 ng/mL and at least four years of follow‐up after initial PSA test were included. ? Optimal PSA threshold and predictive value of PSA for development of prostate cancer were calculated.RESULTS
? Prostate cancer rates were 15‐fold higher in patients with PSA ≥1.5 ng/mL vs patients with PSA <1.5 ng/mL (7.85% vs 0.51%). ? African American patients with baseline PSA <1.5 ng/mL faced prostate cancer rates similar to the whole study population (0.54% vs 0.51%, respectively), while African American patients with PSA 1.5–4.0 ng/mL faced a 19‐fold increase in prostate cancer.CONCLUSION
? Both Caucasian and African American men with baseline PSA values between 1.5 and 4.0 ng/mL are at increased risk for future prostate cancer compared with those who have an initial PSA value below the 1.5 ng/mL threshold. ? Based on a growing body of literature and this analysis, it is recommended that a first PSA test threshold of 1.5 ng/mL and above, or somewhere between 1.5 and 4.0 ng/mL, represent the Early‐Warning PSA Zone (EWP Zone). ? This should serve to inform patients and clinicians alike to future clinical activities with respect to prostate cancer and BPH. 相似文献14.
Daniel M. Moreira Joseph C. Presti Jr William J. Aronson Martha K. Terris Christopher J. Kane Christopher L. Amling Stephen J. Freedland 《BJU international》2010,105(11):1541-1547
Study Type – Prognosis (inception cohort)Level of Evidence 1b
OBJECTIVES
To define a level of persistently elevated prostate‐specific antigen (PSA) after radical prostatectomy (RP) that equates with high‐risk for disease progression, and to identify preoperative predictors of PSA persistence among men from the Shared Equal Access Regional Cancer Hospital (SEARCH) database.PATIENTS AND METHODS
A total of 901 men treated with RP between 2001 and 2008 were separated into groups based upon PSA nadir within 6 months after RP. We explored the association between nadir groups and time to biochemical recurrence (BCR) using multivariate Cox proportional hazards and determined the preoperative predictors of PSA persistence using logistic regression.RESULTS
Relative to men with undetectable PSA levels, those with a PSA nadir of 0.03 (hazard ratio [HR] 3.88, P < 0.001), 0.04 (HR 4.87, P < 0.001), 0.05–0.09 (HR 12.69, P < 0.001), 0.1–0.19 (HR 13.17, P < 0.001), and 0.2 ng/mL (HR 13.23, P < 0.001) were at increased risk of BCR while men with a nadir of 0.01 (HR 1.36, P = 0.400) and 0.02 (HR 1.64, P = 0.180) were not. Using the PSA persistence definition of a PSA nadir ≥0.03 ng/mL, 230 men (26%) had persistence. The independent preoperative predictors of PSA persistence were higher body mass index (BMI, P = 0.002), pathological Gleason score (relative to 2–6: 4 + 3–10, P = 0.001) and preoperative PSA level (P < 0.001).CONCLUSIONS
Men with a PSA nadir ≥0.03 ng/mL after RP were at higher risk for BCR. Using a PSA persistence definition of a PSA nadir ≥0.03 ng/mL, persistence was predicted by known factors associated with aggressive disease (tumour grade, PSA level and BMI). Validation of the present definition in different populations using later end‐points remains necessary to assess its prognostic usefulness. 相似文献15.
Thomas Ripert Younes Bayoud Rabah Messaoudi Johann Ménard Marie-Dominique Azémar Fran?ois Duval Tan Dat Nguyen Frédéric Staerman 《Canadian Urological Association journal》2012,6(5):E179-E183
Background:
The objective of this study is to evaluate the feasibility, tolerance and efficacy of salvage external beam radiotherapy (EBRT) in persistent or recurrent prostate cancer after failed high intensity focused ultrasound (HIFU) therapy.Methods:
We reviewed data on tolerance and oncologic outcomes for all patients with biopsy-proven locally recurrent or persistent prostate cancer who underwent salvage EBRT in our department between April 2004 and June 2008. Minimum follow-up for inclusion was 2 years. Failure with EBRT was defined as biochemical relapse (Phoenix definition) or introduction of androgen deprivation therapy (ADT). Gastrointestinal and urinary toxicity and urinary stress incontinence were scored at 12 and 24 months (Radiation Therapy Oncology Group and Ingelman Sundberg rating, respectively).Results:
The mean age of the patients was 68.8 years (range: 60–79). Mean prostate-specific antigen (PSA) before EBRT was 5.57 ng/mL (range: 2.5–14.8). Median follow-up was 36.5 ± 10.9 months (range: 24–54). No patient received adjunctive ADT. The EBRT course was well-tolerated and completed by all patients. The mean PSA nadir was 0.62 ng/mL (range: 0.03–2.4) and occurred after a median of 22 months (range: 12–36). One patient experienced biochemical failure and was prescribed ADT 30 months after EBRT. The disease-free survival rate was 83.3% at 36.5 months. There was no major EBRT-related toxicity at 12 or 24 months.Conclusions:
Our early clinical results confirm the feasibility and good tolerance of salvage radiotherapy after HIFU failure. Oncological outcomes were promising. A prospective study with longer follow-up is needed to identify factors predictive of success for salvage EBRT therapy after HIFU failure. 相似文献16.
OBJECTIVE: To explore the association between the prostate-specific antigen (PSA) nadir after transrectal high-intensity focused ultrasound (HIFU) therapy for organ-confined prostate cancer and subsequent treatment failure, as defined by the presence of residual disease at biopsy 6 months after treatment. PATIENTS AND METHODS: Between January 1999 and January 2005, 115 patients in a Japanese hospital were treated using a transrectal HIFU system (Sonablate, Focus Surgery, IN, USA) for presumed localized adenocarcinoma of the prostate. All treatments were primary and none of the patients had received hormone therapy. The PSA level was measured at 2-monthly intervals and all patients had a transrectal prostate biopsy taken at 6 months. Multiple logistic regression was used to examine the relationship between PSA nadir and treatment failure, as defined by the presence of disease at biopsy. RESULTS: The PSA nadir was strongly associated with treatment failure (P < 0.001). Patients with a PSA nadir of 0.0-0.2 ng/mL had a treatment failure rate of only 11% (four of 36), compared to 46% (17 of 37) in patients with a PSA nadir of 0.21-1.00 ng/mL and 48% (20 of 42) with a PSA nadir of >1.0 ng/mL. In addition, the PSA nadir was strongly associated with both preoperative PSA level and residual prostate volume. CONCLUSION: There is a clear and intuitive association between the PSA nadir and the risk of treatment failure after HIFU. These data can be used to predict the risk of residual disease in patients with prostate cancer undergoing HIFU therapy. They can also be used to inform where the target PSA nadir should be set for this novel therapy. 相似文献
17.
First analysis of the long-term results with transrectal HIFU in patients with localised prostate cancer 总被引:1,自引:0,他引:1
Blana A Murat FJ Walter B Thuroff S Wieland WF Chaussy C Gelet A 《European urology》2008,53(6):1194-1201
OBJECTIVE: To evaluate the long-term efficacy of high-intensity focused ultrasound (HIFU) therapy for patients with localised prostate cancer. MATERIAL AND METHODS: Patients included in this multicentre analysis had T1-T2 NxM0 prostate cancer, a PSA<15 ng/ml, and a Gleason score (GS) < or = 7, and were treated with prototypes or first-generation Ablatherm HIFU devices between October 1997 and August 2001. The Phoenix definition of biochemical failure was used (PSA nadir+2). Treatment failure was defined as: biochemical failure or positive biopsy. RESULTS: A total of 140 patients with a mean (SD) age 69.1 yr (6.6) were included. Mean (SD) follow-up was 6.4 yr (1.1). Control prostate biopsies were negative in 86.4% of patients. Median PSA nadir of 0.16 ng/ml (range, 0.0-9.1) was achieved at a mean (SD) of 4.9 mo (5.2). A PSA nadir < or = 0.5 ng/ml was recorded in 68.4% of patients. The actuarial biochemical failure-free survival rates (SR) at 5 and 7 yr were 77% and 69%, respectively. The actuarial disease-free SR at 5 and 7 yr were 66% and 59%, respectively. CONCLUSIONS: This study demonstrates the effective long-term cancer control achieved with HIFU in patients with low- or intermediate-risk localised prostate cancer. 相似文献
18.
Ganzer R Rogenhofer S Walter B Lunz JC Schostak M Wieland WF Blana A 《European urology》2008,53(3):547-553
OBJECTIVES: To assess if prostate-specific antigen (PSA) nadir is an independent predictor of treatment failure and disease-free survival after high-intensity focussed ultrasound (HIFU) therapy for localised prostate cancer as defined by the new ASTRO criteria. METHODS: One hundred three patients after HIFU treatment (Ablatherm, EDAP, Lyon, France) for localised prostate cancer without previous hormonal therapy were evaluated retrospectively. Patients attended regular follow-up visits every 3 mo. Treatment failure was defined by the revised ASTRO criteria (PSA >or=2 ng/ml above nadir PSA, positive biopsy, if salvage treatment was administered). Patients were divided into three PSA nadir subgroups (group 1, 1 ng/ml). The disease-free survival rate (DFSR) was calculated by using life table methods. The log-rank test was used to compare the curves based on Kaplan-Meier models. RESULTS: The median follow-up was 4.9 (3-8.6) yr. Mean time to PSA nadir was 6.4+/-5.1 mo. A PSA nadir of 1ng/ml was reached by 64%, 22.3%, and 13.6% of patients, respectively. Treatment failure rates during follow-up were 4.5%, 30.4%, and 100%, respectively, for the three groups (p<0.001). The actuarial DFSRs at 5 yr were 95%, 55%, and 0%, respectively, for the 3 groups (p<0.001). CONCLUSIONS: The PSA nadir after HIFU correlates highly significantly with treatment failure and DFSR, and can be applied in daily clinical practice. Promising oncological outcome is obtained if a PSA nadir of 相似文献
19.
Fritz H. Schröder Chris H. Bangma Johannes M. Wolff Antonio Alcaraz Francesco Montorsi Pierre Mongiat‐Artus Per‐Anders Abrahamsson Tom A. McNicholas Ramiro S. Castro Indrani M. Nandy 《BJU international》2009,103(5):590-596
OBJECTIVE
To describe the Avodart after Radical Therapy for prostate cancer Study (ARTS), investigating the use of dutasteride (a dual 5α‐reductase inhibitor that suppresses intraprostatic dihydrotestosterone, reduces tumour volume and improves other markers of tumour regression in prostate cancer) to prevent or delay disease progression in patients with biochemical recurrence after therapy with curative intent.PATIENTS AND METHODS
An increasing serum prostate‐specific antigen (PSA) level after radical prostatectomy (RP) or radiotherapy (RT) is indicative of recurrent prostate cancer and typically pre‐dates clinically detectable metastatic disease by several years. ARTS is an ongoing European multicentre trial in which patients are stratified by previous therapy (RP with or without salvage RT vs primary RT) and randomized to double‐blind treatment with dutasteride 0.5 mg or placebo once daily for 2 years. Eligible patients will have a PSA doubling time (DT) of 3–24 months. Biochemical recurrence is defined as three increases in PSA level from the nadir, with each increase ≥4 weeks apart and each PSA level ≥0.2 ng/mL, and a final PSA level of ≥0.4 ng/mL (after RP) or ≥2 ng/mL (after primary RT). Study endpoints include time to PSA doubling, time to disease progression, treatment response (PSA decrease or an increase of ≤15% from baseline), changes in PSA and PSADT, and changes in anxiety (Memorial Anxiety Scale for Prostate Cancer).CONCLUSIONS
ARTS will be the first study to evaluate the effects of dutasteride on PSADT, disease progression and treatment response in patients with biochemical failure after RP or RT, and should help to elucidate the potential role of dual 5α‐reductase inhibition in prostate cancer. 相似文献20.
David S. Aaronson Ichiro Yamasaki Alexander Gottschalk Joycelyn Speight I‐Chow Hsu Barby Pickett Mack Roach III Katsuto Shinohara 《BJU international》2009,104(5):600-604