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1.
Sebastien Crouzet Xavier Rebillard Daniel Chevallier Pascal Rischmann Gilles Pasticier Gregory Garcia Olivier Rouviere Jean-Yves Chapelon Albert Gelet 《European urology》2010
Background
High-intensity focused ultrasound (HIFU) is an emerging treatment for select patients with localized prostate cancer (PCa).Objectives
To report the oncologic outcome of HIFU as a primary care option for localized prostate cancer from a multicenter database.Design, setting, and participants
Patients with localized PCa treated with curative intent and presenting at least a 2-yr follow-up from February 1993 were considered in this study. Previously irradiated patients were excluded from this analysis. In case of any residual or recurrent PCa, patients were systematically offered a second session. Kaplan-Meier analysis was performed to determine disease-free survival rates (DFSR).Measurements
Prostate-specific antigen (PSA), clinical stage, and pathologic results were measured pre- and post-HIFU.Results and limitations
A total of 803 patients from six urologic departments met the inclusion criteria. Stratification according to d’Amico's risk group was low, intermediate, and high in 40.2%, 46.3%, and 13.5% of patients, respectively. Mean follow-up was 42 ± 33 mo. Mean PSA nadir was 1.0 ± 2.8 ng/ml with 54.3% reaching a nadir of ≤0.3 ng/ml. Control biopsies were negative in 85% of cases. The overall and cancer-specific survival rates at 8 yr were 89% and 99%, respectively. The metastasis-free survival rate at 8 yr was 97%. Initial PSA value and Gleason score value significantly influence the DFSR. The 5- and 7-yr biochemical-free survival rates (Phoenix criteria) were 83–75%, 72–63%, and 68–62% (p = 0.03) and the additional treatment-free survival rates were 84–79%, 68–61%, and 52–54% (p < 0.001) for low-, intermediate-, and high-risk patients, respectively. PSA nadir was a major predictive factor for HIFU success: negative biopsies, stable PSA, and no additional therapy.Conclusions
Local control and DFSR achieved with HIFU were similar to those expected with conformal external-beam radiation therapy (EBRT). The excellent cancer-specific survival rate is also explained by the possibility to repeat HIFU and use salvage EBRT. 相似文献2.
Schröder FH Kurth KH Fossa SD Hoekstra W Karthaus PP De Prijck L Collette L 《European urology》2009,55(1):14-22
Background
The timing of endocrine treatment (ET) for prostate cancer (PCa) remains controversial. The issue is addressed in European Organisation for the Research and Treatment of Cancer (EORTC) protocol 30846 for patients with lymph node–positive (pN1-3) cancer without local treatment of the primary tumour.Objective
To evaluate the effect of early versus delayed treatment in pN1-3 PCa.Design, setting, and participants
Two hundred thirty-four patients with histologically proven PCa and nodal metastases (pN1-3) were randomized to immediate versus delayed ET without treatment of the primary tumour. ET consisted of a depot luteinising hormone-releasing hormone (LHRH) agonist and 1 mo of an anti-androgen or surgical castration. The trial's main objective was to show non-inferiority of delayed ET to immediate ET by ruling out a hazard ratio (HR) of 1.50 for overall survival (OS), with 85% power at one-sided α = 5%.Measurements
All but three patients were treated as randomized. The median follow-up is 13 yr. The median protocol treatment duration was 2.7 yr in the delayed and 3.2 yr in the immediate ET groups.Results and limitations
Overall, 193 patients (82.5%) have died (97 on delayed ET and 96 on immediate ET), 59.4% of them as a result of PCa. The intention-to-treat analysis shows a 22% increase in the hazard of death of those randomized to delayed treatment (HR = 1.22, 95% confidence interval [CI]: 0.92, 1.62). The difference is not statistically significant, but non-inferiority is also not proved.The median OS on immediate ET is 7.6 yr (95% CI, 6.3–8.3 yr) versus 6.1 yr (95% CI, 5.7–7.3 yr) in the delayed ET group. The 10-yr cumulative incidence of death resulting from PCa was 55.6% in the delayed ET group versus 52.1% with immediate ET group. Similar conclusions hold for PCa-specific survival.Conclusions
After 13 years of follow-up, survival or PCa-specific survival between immediate and delayed ET appear similar, but the trial is underpowered to reach its goal of showing non-inferiority. 相似文献3.
Marcin Popiolek Jennifer R. Rider Ove Andrén Sven-Olof Andersson Lars Holmberg Hans-Olov Adami Jan-Erik Johansson 《European urology》2013
Background
Most localized prostate cancers are believed to have an indolent course. Within 15 yr of diagnosis, most deaths among men with prostate cancer (PCa) can be attributed to other competing causes. However, data from studies with extended follow-up are insufficient to determine appropriate treatment for men with localized disease.Objective
To investigate the long-term natural history of untreated, early-stage PCa.Design, setting, and participants
We conducted a population-based, prospective-cohort study using a consecutive sample of 223 patients with untreated, localized PCa from a regionally well-defined catchment area in central Sweden. All subjects were initially managed with observation. Androgen deprivation therapy was administered when symptomatic tumor progression occurred.Outcome measurements and statistical analysis
Based on >30 yr of follow-up, the main outcome measures were: progression-free, cause-specific, and overall survival, and rates of progression and mortality per 1000 person-years.Results and limitations
After 32 yr of follow-up, all but 3 (1%) of the 223 men had died. We observed 90 (41.4%) local progression events and 41 (18.4%) cases of progression to distant metastasis. In total, 38 (17%) men died of PCa. Cause-specific survival decreased between 15 and 20 yr, but stabilized with further follow-up. All nine men with Gleason grade 8–10 disease died within the first 10 yr of follow-up, five (55%) from PCa. Survival for men with well-differentiated, nonpalpable tumors declined slowly through 20 yr, and more rapidly between 20 and 25 yr (from 75.2% [95% confidence interval, 48.4–89.3] to 25% [95% confidence interval, 22.0–72.5]). It is unclear whether these data are relevant for tumors detected by elevated prostate-specific antigen levels.Conclusions
Although localized PCa most often has an indolent course, local progression and distant metastasis can develop over the long term, even among patients considered low risk at diagnosis. 相似文献4.
5.
Fritz H. Schröder Roderick C.N. van den BerghTineke Wolters Pim J. van LeeuwenChris H. Bangma Theo H. van der KwastMonique J. Roobol 《European urology》2010
Background
The appropriate way of biopsying a prostate remains controversial. Is sextant biopsy still adequate with repeat screening?Objective
Within the European Randomized Study of Screening for Prostate Cancer (ERSPC), lateralized sextant biopsies were applied. In this analysis we use distant end points to study the fate of prostate cancers (PCa) potentially missed by initial biopsies.Design, setting, and participants
This retrospective study included 19 970 men ages 55–74 identified from the Rotterdam population registry and screened repeatedly for PCa between 1993 and 2005. PCa detected later in men with initially negative biopsies were considered as missed. Rescreening every 4 yr and a complete follow-up of 11 yr allowed an inventory of progressive and deadly disease in these men.Intervention
Sextant biopsies initially, later lateralized, in screen-positive men.Measurements
The fate of PCa potentially missed by initial sextant biopsies in terms of progression-free and PCa-specific survival were the main outcome measures. Kaplan-Meier analysis was used to evaluate differences between subgroups.Results and limitations
In 3056 men with negative biopsies at the first screen, 287 PCa were subsequently detected. Of these 287 cases, 26 developed progressive disease and 7 died of PCa. Poor outcomes were encountered mainly in 20 interval cases. The seven PCa deaths in men with initially negative biopsies amounted to only 0.03% compared to the 0.35% PCa death rate in the whole population of 19 970 men. Limitations include the retrospective character of this analysis.Conclusions
The number of potentially missed cancers with a poor outcome in terms of progression-free survival and deaths from PCa is very low. Despite some limitations, our data show that lateralized sextant biopsy is not obsolete if repeated screening is applied. 相似文献6.
Background
Previous studies demonstrate that androgen-deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists and orchiectomy for prostate cancer (PCa) is associated with cardiovascular disease. However, few studies have examined its effect on the peripheral vascular system.Objective
To study the risk of peripheral artery disease (PAD) and venous thromboembolism associated with ADT for PCa.Design, settings, and participants
This was a population-based observational study of 182 757 US men ≥66 yr of age who were diagnosed with nonmetastatic PCa from 1992 to 2007, with a median follow-up of 5.1 yr, of whom 47.8% received GnRH agonists and 2.2% orchiectomy.Measurements
We used Cox proportional hazards models with time-varying treatment variables to adjust for demographic and tumor characteristics in assessing whether treatment with GnRH agonists or orchiectomy were associated with PAD and/or venous thromboembolism.Results and limitations
GnRH agonist use was associated with an increased risk of incident PAD (adjusted hazard ratio [HR]: 1.16; 95% confidence interval [CI], 1.12–1.21) and incident venous thromboembolism (adjusted HR: 1.10; 95% CI, 1.04–1.15). In addition, orchiectomy was associated with an increased risk of peripheral arterial disease (adjusted HR: 1.13; 95% CI, 1.02–1.26) and venous thromboembolism (adjusted HR: 1.27; 95% CI, 1.11–1.45). Limitations include the observational study design and the inability to assess the use of oral antiandrogens.Conclusions
ADT for nonmetastatic PCa is associated with an increased risk of PAD and venous thromboembolism. Additional research is needed to better understand the potential risks and benefits of ADT, so that this treatment can be targeted to patients for whom the benefits are clearest. 相似文献7.
Christopher J. Keto William J. Aronson Martha K. Terris Joseph C. Presti Christopher J. Kane Christopher L. Amling Stephen J. Freedland 《European urology》2014
Background
A prostate-specific antigen (PSA) level <0.2 ng/ml 8 mo after starting on androgen-deprivation therapy (ADT) is correlated with better outcomes. However, not all men reach a nadir PSA level within 8 mo. Whether the lowest PSA on ADT—specifically, <0.2 ng/ml—can be used for risk stratification is untested.Objective
We examined the predictive value of small but detectable PSA nadir values on prostate cancer (PCa)–specific outcomes in men treated with early ADT after radical prostatectomy (RP).Design, setting, and participants
We performed a retrospective review of men treated with ADT after RP before metastases from the SEARCH database. We identified 402 men treated with ADT for elevated PSA following RP, of whom 294 men had complete data. Median follow-up after PSA nadir was 49 mo. All men had a PSA nadir <4 ng/ml; 223 men (76%) had an undetectable nadir.Intervention
ADT for an elevated PSA following RP with no radiographic evidence of metastatic disease.Outcome measurements and statistical analysis
PSA nadir on ADT was defined as the lowest PSA value during ADT. Proportional hazards models and the C index were used to test the association and predictive accuracy, respectively, between PSA nadir and PCa-specific outcomes.Results and limitations
Men with a PSA nadir between 0.01 and 0.2 ng/ml had a greater risk of progression to castration-resistant PCa (CRPC) (hazard ratio [HR]: 5.14; p < 0.001), metastases (HR: 3.98; p = 0.006), and PCa-specific mortality (PCSM) (HR: 5.33; p = 0.003) than men with an undetectable nadir. When data were restricted to men followed with ultrasensitive PSA values (sensitivity of 0.01 ng/ml), the C index of PSA nadir alone for predicting CRPC, metastases, and PCSM was 0.88, 0.91, and 0.96, respectively.Conclusions
A PSA nadir on ADT, even at a very low level, strongly predicts progression to CRPC, metastases, and PCSM. Men with a detectable PSA nadir during ADT should be considered for clinical trials. 相似文献8.
Mani Menon Mahendra Bhandari Nilesh Gupta Zhaoli Lane James O. Peabody Craig G. Rogers Jesse Sammon Sameer A. Siddiqui Mireya Diaz 《European urology》2010
Background
There is a paucity of data on long-term oncologic outcomes for patients undergoing robot-assisted radical prostatectomy (RARP) for prostate cancer (PCa).Objective
To evaluate oncologic outcomes in patients undergoing RARP at a high-volume tertiary center, with a focus on 5-yr biochemical recurrence–free survival (BCRFS).Design, setting, and participants
The study cohort consisted of 1384 consecutive patients with localized PCa who underwent RARP between September 2001 and May 2005 and had a median follow-up of 60.2 mo. No patient had secondary therapy until documented biochemical recurrence (BCR). BCR was defined as a serum prostate-specific antigen ≥0.2 ng/ml with a confirmatory value. BCRFS was estimated using the Kaplan-Meier method. Event–time distributions for the time to failure were compared using the log-rank test. Univariable and multivariable Cox proportional hazards regression models were used to determine variables predictive of BCR.Intervention
All patients underwent RARP.Measurements
BCRFS rates were measured.Results and limitations
This cohort of patients had moderately aggressive PCa: 49.0% were D’Amico intermediate or high risk on biopsy; however, 60.9% had Gleason 7–10 disease, and 25.5% had ≥T3 disease on final pathology. There were 189 incidences of BCR (31 per 1,000 person years of follow-up) at a median follow-up of 60.2 mo (interquartile range [IQR]: 37.2–69.7). The actuarial BCRFS was 95.1%, 90.6%, 86.6%, and 81.0% at 1, 3, 5, and 7 yr, respectively. In the patients who recurred, median time to BCR was 20.4 mo; 65% of BCR incidences occurred within 3 yr and 86.2% within 5 yr. On multivariable analysis, the strongest predictors of BCR were pathologic Gleason grade 8–10 (hazard ratio [HR]: 5.37; 95% confidence interval [CI], 2.99–9.65; p < 0.0001) and pathologic stage T3b/T4 (HR: 2.71; 95% CI, 1.67–4.40; p < 0.0001).Conclusions
In a contemporary cohort of patients with localized PCa, RARP confers effective 5-yr biochemical control. 相似文献9.
Yu-Ning Wong Stephen J. Freedland Brian Egleston Neha Vapiwala Robert Uzzo Katrina Armstrong 《European urology》2009,56(4):609-616
Background
Primary androgen deprivation therapy (PADT) is frequently used as a sole modality of treatment in men with localized prostate cancer, despite a lack of clinical trial data supporting its use.Objective
To measure the impact of treatment with PADT compared to observation on overall survival in men with organ-confined prostate cancer.Design, setting, and participants
The design was for an observational cohort from Surveillance, Epidemiology, and End Results (SEER) Medicare data. The cohort consisted of 16 535 men aged 65–80 yr at diagnosis with organ-confined well-differentiated or moderately differentiated prostate cancer who survived >1 yr past diagnosis and did not undergo treatment with prostatectomy or radiation therapy within 6 mo of diagnosis. They were diagnosed between 1991 and 1999 and followed until death or until the end of the study period (December 31, 2002).Intervention
Study subjects were selected to receive PADT alone if they received luteinizing hormone-releasing hormone agonists or bilateral orchiectomy in the first 6 mo after diagnosis, and they were selected to be observed if they did not have claims for PADT during the same interval.Measurements
Overall survival.Results and limitations
After adjusting for potential confounders (ie, tumor characteristics, comorbidities, and demographics), patients who received ADT had a worse overall survival rate than patients who were observed (hazard ratio: 1.20; 95% confidence interval: 1.13–1.27).In observational studies there may be unmeasured differences between the treated and untreated groups. The SEER database does not provide information on prostate-specific antigen levels.Conclusions
This large, population-based study suggests that PADT did not improve survival in men with localized prostate cancer, but it suggests that PADT may instead result in worse outcomes compared with observation. Patients and physicians should be cognizant of the potential long-term side effects of ADT in a patient population for which expectant observation is an acceptable treatment strategy. 相似文献10.
Georgios Gakis Stephen A. Boorjian Alberto Briganti Steven Joniau Guram Karazanashvili R. Jeffrey Karnes Agostino Mattei Shahrokh F. Shariat Arnulf Stenzl Manfred Wirth Christian G. Stief 《European urology》2014
Context
Because pelvic lymph node (LN)-positive prostate cancer (PCa) is generally considered a regionally metastatic disease, surgery needs to be better defined.Objective
To review the impact of radical prostatectomy (RP) and pelvic lymph node dissection (PLND), possibly in conjunction with a multimodal approach using local radiotherapy and/or androgen-deprivation therapy (ADT), in LN-positive PCa.Evidence acquisition
A systematic Medline search for studies reporting on treatment regimens and outcomes in patients with LN-positive PCa undergoing RP between 1993 and 2012 was performed.Evidence synthesis
RP can improve progression-free and overall survival in LN-positive PCa, although there is a lack of high-level evidence. Therefore, the former practice of aborting surgery in the presence of positive nodes might no longer be supported by current evidence, especially in those patients with a limited LN tumor burden. Current data demonstrate that the lymphatic spread takes an ascending pathway from the pelvis to the retroperitoneum, in which the internal and the common iliac nodes represent critical landmarks in the metastatic distribution. Sophisticated imaging technologies are still under investigation to improve the prediction of LN-positive PCa. Nonetheless, extended PLND including the common iliac arteries should be offered to intermediate- and high-risk patients to improve nodal staging with a possible benefit in prostate-specific antigen progression-free survival by removing significant metastatic load. Adjuvant ADT has the potential to improve overall survival after RP; the therapeutic role of a trimodal approach with adjuvant local radiotherapy awaits further elucidation. Age is a critical parameter for survival because cancer-specific mortality exceeds overall mortality in younger patients (<60 yr) with high-risk PCa and should be an impetus to treat as thoroughly as possible.Conclusions
Increasing evidence suggests that RP and extended PLND improve survival in LN-positive PCa. Our understanding of surgery of the primary tumor in LN-positive PCa needs a conceptual change from a palliative option to the first step in a multimodal approach with a significant improvement of long-term survival and cure in selected patients. 相似文献11.
Grace L. Lu-Yao Peter C. Albertsen Hui Li Dirk F. Moore Weichung Shih Yong Lin Robert S. DiPaola Siu-Long Yao 《European urology》2012
Background
Despite evidence that shows no survival advantage, many older patients receive primary androgen-deprivation therapy (PADT) shortly after the diagnosis of localized prostate cancer (PCa).Objective
This study evaluates whether the early use of PADT affects the subsequent receipt of additional palliative cancer treatments such as chemotherapy, palliative radiation therapy, or intervention for spinal cord compression or bladder outlet obstruction.Design, setting, and participants
This longitudinal population-based cohort study consists of Medicare patients aged ≥66 yr diagnosed with localized PCa from 1992 to 2006 in areas covered by the Surveillance Epidemiology and End Results (SEER) program. SEER-Medicare linked data through 2009 were used to identify the use of PADT and palliative cancer therapy.Outcome measurements and statistical analysis
Instrumental variable analysis methods were used to minimize confounding effects. Confidence intervals were derived from the bootstrap estimates.Results and limitations
This study includes 29 775 men who did not receive local therapy for T1–T2 PCa within the first year of cancer diagnosis. Among low-risk patients (Gleason score 2–7 in 1992–2002 and Gleason score 2–6 in 2003–2006) with a median age of 78 yr and a median follow-up of 10.3 yr, PADT was associated with a 25% higher use of chemotherapy (hazard ratio [HR]: 1.25; 95% confidence interval [CI], 1.08–1.44) and a borderline higher use of any palliative cancer treatment (HR: 1.07; 95% CI, 0.97–1.19) within 10 yr of diagnosis in regions with high PADT use compared with regions with low PADT use. Because this study was limited to men >65 yr, the results may not be applicable to younger patients.Conclusions
Early treatment of low-risk, localized PCa with PADT does not delay the receipt of subsequent palliative therapies and is associated with an increased use of chemotherapy. 相似文献12.
Context
Androgen-deprivation therapy (ADT) plays a pivotal role in the management of locally advanced and metastatic prostate cancer (PCa). When and for how long to apply ADT have remained controversial issues.Objective
To review randomised studies of ADT (orchiectomy or luteinising hormone-releasing hormone analogues) in PCa—both immediate and deferred/adjuvant studies—to elucidate a possible interaction between local treatment and ADT.Evidence acquisition
Published randomised studies on ADT in various stages of PCa were included in this review.Evidence synthesis
Studies of immediate versus deferred ADT without local treatment consistently showed only limited benefit for overall survival (OS; hazard ratio [HR]: 0.90; 95% confidence interval [CI], 0.83–0.97) and cancer-specific survival (CSS; HR: 0.79; 95% CI, 0.71–0.89). In contrast, ADT as an adjuvant to radiation therapy in patients with high-risk localised disease or locally advanced disease was associated with substantial OS and CSS benefits. A similar benefit was seen in patients with proven systemic disease (node-positive patients after radical prostatectomy). Overall, the data suggest a clinically important survival benefit (HR for OS: 0.69; 95% CI, 0.61–0.79) when a local treatment has been applied to the primary tumour. Possible mechanisms of this therapeutic effect are discussed.Conclusions
We conclude that an interaction between local treatment and ADT is suggested by this systematic review. In patients with advanced and aggressive disease who are at a high risk to die from PCa and who are treated for their primary tumour with curative intent, immediate and sustained ADT improves OS and CSS significantly. The local therapy in T3 and/or lymph node–positive disease is an essential part of the optimal treatment. However, this intensive treatment is unnecessary in a substantial number of patients with T3 and/or N1 disease with a slow natural history or high competing death risk. 相似文献13.
Giorgio Gandaglia Maxine Sun Jim C. Hu Giacomo Novara Toni K. Choueiri Paul L. Nguyen Jonas Schiffmann Markus Graefen Shahrokh F. Shariat Firas Abdollah Alberto Briganti Francesco Montorsi Quoc-Dien Trinh Pierre I. Karakiewicz 《European urology》2014
Background
Androgen deprivation therapy (ADT) might increase the risk of acute kidney injury (AKI) in patients with prostate cancer (PCa).Objective
To examine the impact of ADT on AKI in a large contemporary cohort of patients with nonmetastatic PCa representing the US population.Design, setting, and participants
Overall, 69 292 patients diagnosed with nonmetastatic PCa between 1995 and 2009 were abstracted from the Surveillance Epidemiology and End Results–Medicare database.Outcomes measurements and statistical analyses
Patient in both treatment arms (ADT vs no ADT) were matched using propensity-score methodology. Ten-year AKI rates were estimated. Competing-risks regression analyses tested the association between ADT and AKI, after adjusting for the risk of death during follow-up.Results and limitations
Overall, the 10-yr AKI rates were 24.9% versus 30.7% for ADT-naive patients versus those treated with ADT, respectively (p < 0.001). When patients were stratified according to the type of ADT, the 10-yr AKI rates were 31.1% versus 26.0% for men treated with gonadotropin-releasing hormone (GnRH) agonists and bilateral orchiectomy, respectively (p < 0.001). In multivariable analyses, the administration of GnRH agonists (hazard ratio [HR]: 1.24; 95% confidence interval [CI], 1.18–1.31; p < 0.001), but not bilateral orchiectomy (HR: 1.11; 95% CI, 0.96–1.29; p = 0.1), was associated with the risk of experiencing AKI. Our study is limited by its retrospective design.Conclusions
ADT is associated with an increased risk of AKI in patients with nonmetastatic PCa. In particular, the administration of GnRH agonists, but not surgical castration, may substantially increase the risk of experiencing AKI. These observations should help provide physicians with better patient selection to reduce the risk of AKI.Patient summary
The administration of gonadotropin-releasing hormone agonists, but not bilateral orchiectomy, increases the risk of acute kidney injury (AKI) in patients with prostate cancer (PCa). These observations should help provide physicians with better patient selection to reduce the risk of AKI in PCa patients. 相似文献14.
Context
High-intensity focussed ultrasound (HIFU) is an emerging minimally invasive treatment option for prostate cancer.Objective
Our aim was to assess the efficacy and safety of HIFU in both primary treatment of men with localised and locally advanced prostate cancer as well as salvage treatment of men with recurrent prostate cancer following treatment failure of radical prostatectomy or external-beam radiation therapy.Evidence acquisition
We conducted a systematic literature search for studies conducted on humans and published in either English or German in several databases from 2000 to 2010. In addition, we screened several Web sites for assessments on HIFU in prostate cancer and contacted the manufacturers of the two currently available HIFU devices for supplemental information on HIFU. We included all prospective studies with >50 study participants and assessed their quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.Evidence synthesis
We identified 20 uncontrolled prospective case series, each of which treated between 58 and 517 patients. These studies were all conducted within the past decade. In total, 3018 patients were treated with HIFU, 93% for primary therapy and 7% for salvage HIFU. For all HIFU procedures, the biochemical disease-free survival rate at 1, 5, and 7 yr, respectively, was 78–84%, 45–84%, and 69%. The negative biopsy rate was 86% at 3 mo and 80% at 15 mo. Overall survival rates and prostate cancer–specific survival rates were 90% and 100% at 5 yr and 83% and 98% at 8 yr, respectively. Adverse events concerned the urinary tract (1–58%), potency (1–77%), the rectum (0–15%), and pain (1–6%). Quality-of-life assessment yielded controversial results.Conclusions
Applying the GRADE approach, the available evidence on efficacy and safety of HIFU in prostate cancer is of very low quality, mainly due to study designs that lack control groups. More research is needed to explore the use of HIFU in prostate cancer. 相似文献15.
Background
Radiotherapy combined with androgen-deprivation therapy (ADT) is superior to radiotherapy alone in localised prostate cancer; however, data comparing ADT alone are somewhat limited.Objective
To compare 3-yr ADT plus radiotherapy with ADT alone in locally advanced prostate cancer patients.Design, setting, and participants
A multicentre randomised open controlled phase 3 trial in 264 histologically confirmed T3–4 or pT3N0M0 prostate cancer patients randomised from March 2000 to December 2003.Intervention
ADT (11.25 mg subcutaneous depot injection of leuprorelin every 3 mo for 3 yr) plus external-beam radiotherapy or ADT alone. Flutamide (750 g/d) was administered for 1 mo.Outcome measurements and statistical analysis
The primary objective was 5 yr progression-free survival (PFS) according to clinical or biologic criteria, using the American Society for Therapeutic Radiology and Oncology (ASTRO) and the newer (Phoenix) definition (nadir plus 2 ng/ml), by intention to treat. Secondary objectives included time to locoregional recurrence and distant metastases, and overall and disease-specific survival. Our Analyses: intent-to-treat analysis, multivariate analyses using a Cox model with a 5% threshold from univariate analysis, and Kaplan-Meier estimates.Results and limitations
ADT alone was administered to 130 patients and combined therapy to 133. With a median follow-up of 67 mo, 5-yr PFS was 60.9% for combined therapy versus 8.5% with ADT alone (ASTRO; p < 0.0001), and 64.7% versus 15.4%, respectively, for Phoenix (p < 0.0011). Locoregional progression was reported in 9.8% of combined-therapy patients versus 29.2% with ADT alone (p < 0.0001) and metastatic progression in 3.0% versus 10.8%, respectively (p < 0.018). Overall survival was 71.4% with combined therapy versus 71.5% with ADT alone; disease-specific survival was 93.2% versus 86.2%. Limitations included the relatively small population and a relatively short follow-up period.Conclusions
Combined therapy strongly favoured improved PFS, locoregional control, and metastasis-free survival. Longer follow-up is needed to assess the potential survival impact. 相似文献16.
Zachary S. Zumsteg Daniel E. Spratt Isaac Pei Zhigang Zhang Yoshiya Yamada Marisa Kollmeier Michael J. Zelefsky 《European urology》2013
Background
The management of intermediate-risk prostate cancer (PCa) is controversial, in part due to the heterogeneous nature of patients falling within this classification.Objective
We propose a new risk stratification system for intermediate-risk PCa to aid in prognosis and therapeutic decision making.Design, setting, and participants
Between 1992 and 2007, 1024 patients with National Comprehensive Cancer Network intermediate-risk PCa and complete biopsy information were treated with definitive external-beam radiation therapy (EBRT) utilizing doses ≥81 Gy. Unfavorable intermediate-risk (UIR) PCa was defined as any intermediate-risk patient with a primary Gleason pattern of 4, percentage of positive biopsy cores (PPBC) ≥50%, or multiple intermediate-risk factors (IRFs; cT2b–c, prostate-specific antigen [PSA] 10–20, or Gleason score 7).Intervention
All patients received EBRT with ≥81 Gy with or without neoadjuvant and concurrent androgen-deprivation therapy (ADT).Outcome measurements and statistical analysis
Univariate and multivariate analyses were performed using a Cox proportional hazards model for PSA recurrence-free survival (PSA-RFS) and distant metastasis (DM). PCa-specific mortality (PCSM) was analyzed using a competing-risk method.Results and limitations
Median follow-up was 71 mo. Primary Gleason pattern 4 (hazard ratio [HR]: 3.26; p < 0.0001), PPBC ≥50% (HR: 2.72; p = 0.0007), and multiple IRFs (HR: 2.20; p = 0.008) all were significant predictors of increased DM in multivariate analyses. Primary Gleason pattern 4 (HR: 5.23; p < 0.0001) and PPBC ≥50% (HR: 4.08; p = 0.002) but not multiple IRFs (HR: 1.74; p = 0.21) independently predicted for increased PCSM. Patients with UIR disease had inferior PSA-RFS (HR: 2.37; p < 0.0001), DM (HR: 4.34; p = 0.0003), and PCSM (HR: 7.39; p = 0.007) compared with those with favorable intermediate-risk disease, despite being more likely to receive neoadjuvant ADT. Short follow-up and retrospective study design are the primary limitations.Conclusions
Intermediate-risk PCa is a heterogeneous collection of diseases that can be separated into favorable and unfavorable subsets. These groups likely will benefit from divergent therapeutic paradigms. 相似文献17.
van den Bergh RC Roemeling S Roobol MJ Aus G Hugosson J Rannikko AS Tammela TL Bangma CH Schröder FH 《European urology》2009,55(1):1-8
Background
The incidence of small, localised, well-differentiated prostate cancer (PCa) is increasing, mainly as a result of screening. Many of these cancers will not progress, and radical therapy may lead to substantial overtreatment. Active surveillance (AS) has emerged as an alternative.Objective
To retrospectively validate the currently used criteria for eligibility for AS.Design, setting, and participants
For this cohort study, data from 616 men who were diagnosed with PCa between 1994 and 2007 at a mean age of 66.3 yr in four centres of the European Randomized Study of Screening for Prostate Cancer (ERSPC) were combined. All patients fit the criteria for AS (prostate-specific antigen [PSA] ≤10.0 ng/ml, PSA-density <0.2 ng/ml per ml, stage T1C/T2, Gleason score ≤3 + 3 = 6, and ≤2 positive biopsy cores), and initially they were managed expectantly. Median follow-up was 3.91 yr.Measurements
Disease specific-, overall-, and treatment-free survival were studied. Present PSA characteristics were assessed and also compared between men who were switching to deferred active therapy during follow-up and men remaining untreated.Results and limitations
The calculated (Kaplan-Meier) 10-yr PCa-specific survival (21 patients at risk) was 100%, which sharply contrasted with 77% overall survival. Men still alive showed favourable PSA characteristics. Although the calculated 10-yr treatment-free survival was only 43%, objective signs of progression often did not indicate the shift to radical treatment. The cohort consisted of men on AS and those on watchful waiting (WW); information on comorbidity or psychological distress was not available.Conclusions
AS seems justified in selected men with screen-detected PCa. Prospective protocol-based AS programs are necessary to optimise selection criteria and to find the appropriate trigger points for switching to active therapy. Possible negative psychological reactions with AS against improved quality of life by withholding side-effects from radical treatment should be considered. 相似文献18.
Background
In a previous publication from the Göteborg randomised screening trial from 2010, biennial prostate-specific antigen (PSA) screening for men ≤69 yr of age was shown to lower prostate cancer (PCa) mortality by 44%. The evidence of the optimal age to stop screening, however, is limited.Objective
To examine the risk of PCa after the discontinuation of screening.Design, setting, and participants
In December 1994, 20 000 men in Göteborg, Sweden, between the ages of 50 and 65 yr were randomised to a screening arm (invited biennially to PSA testing) and a control arm (not invited). At the upper age limit (average: 69 yr), a total of 13 423 men (6449 and 6974 in the screening and control arms, respectively) were still alive without PCa. The incidence of PCa hereafter was established by matching with the Western Swedish Cancer Register. Participants were followed until a diagnosis of PCa, death, or final follow-up on June 30, 2012, or for a maximum of 12 yr after the last invitation.Outcome measurements and statistical analysis
Incidence rates and disease-free survival were calculated with life table models and Kaplan-Meier estimates. A competing risk model was also applied.Results and limitations
Postscreening, 173 cases of PCa were diagnosed in the screening arm (median follow-up: 4.8 yr) and 371 in the control arm (median follow-up: 4.9 yr). Up to 9 yr postscreening, all risk groups were more commonly diagnosed in the control arm, but after 9 yr the rates in the screening arm caught up, other than those for the low-risk group. PCa mortality also caught up after 9 yr.Conclusions
Nine years after the termination of PSA testing, the incidence of potentially lethal cancers equals that of nonscreened men. Considering the high PCa mortality rate in men >80 yr of age, a general age of 70 yr to discontinue screening might be too low. Instead, a flexible age to discontinue based on individual risk stratification should be recommended. 相似文献19.
Background
Androgen-deprivation therapy (ADT) for prostate cancer (PCa) may be associated with cardiovascular disease and diabetes. Some data suggest that men with certain conditions may be more susceptible to developing cardiovascular disease than others.Objective
To assess whether the risk of myocardial infarction (MI) or diabetes during ADT is modified by specific baseline comorbidities.Design, setting, and participants
We conducted a population-based observational study of 185 106 US men ≥66 yr of age diagnosed with local/regional PCa from 1992 to 2007. We assessed comorbidities monthly over the follow-up period.Outcome measurements and statistical analysis
Cox proportional hazards models with time-varying variables assessing incident diabetes or MI.Results and limitations
A total of 49.9% of the men received ADT during follow-up. Among men with no comorbidities, ADT was associated with an increase in the adjusted hazard of MI (adjusted hazard ratio [AHR]: 1.09; 95% confidence interval [CI], 1.02–1.16) and diabetes (AHR: 1.33; 95% CI, 1.27–1.39). Risks of MI and diabetes were similarly increased among men with and without specific comorbid illnesses (p > 0.10 for all interactions, with one exception). Previous MI, congestive heart failure, peripheral arterial disease, stroke, hypertension, chronic obstructive pulmonary disease, and renal disease were associated with new MI and diabetes, and obesity and rheumatologic disease were also associated with diabetes. Limitations include the observational study design, reliance on administrative data to ascertain outcomes, and lack of information on risk factors such as smoking and family history.Conclusions
Traditional risk factors for MI and diabetes were also associated with developing these conditions during ADT but did not significantly modify the risk attributable to ADT. Strategies to screen and prevent diabetes and cardiovascular disease in men with PCa should be similar to the strategies recommended for the general population. 相似文献20.
Axel Heidenreich Patrick J. Bastian Joaquim Bellmunt Michel Bolla Steven Joniau Theodor van der Kwast Malcolm Mason Vsevolod Matveev Thomas Wiegel F. Zattoni Nicolas Mottet 《European urology》2014