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BMJ (Clinical Research Ed.) Sep 2018To investigate the efficacy and safety of prostate-specific antigen (PSA) testing to screen for prostate cancer. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To investigate the efficacy and safety of prostate-specific antigen (PSA) testing to screen for prostate cancer.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Electronic search of Cochrane Central Register of Controlled Trials, Web of Science, Embase, Scopus, OpenGrey, LILACS, and Medline, and search of scientific meeting abstracts and trial registers to April 2018.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Randomised controlled trials comparing PSA screening with usual care in men without a diagnosis of prostate cancer.
DATA EXTRACTION
At least two reviewers screened studies, extracted data, and assessed the quality of eligible studies. A parallel guideline committee Rapid Recommendation) provided input on the design and interpretation of the systematic review, including selection of outcomes important to patients. We used a random effects model to obtain pooled incidence rate ratios (IRR) and, when feasible, conducted subgroup analyses (defined a priori) based on age, frequency of screening, family history, ethnicity, and socioeconomic level, as well as a sensitivity analysis based on the risk of bias. The quality of the evidence was assessed with the GRADE approach.
RESULTS
Five randomised controlled trials, enrolling 721 718 men, were included. Studies varied with respect to screening frequency and intervals, PSA thresholds for biopsy, and risk of bias. When considering the whole body of evidence, screening probably has no effect on all-cause mortality (IRR 0.99, 95% CI 0.98 to 1.01; moderate certainty) and may have no effect on prostate-specific mortality (IRR 0.96, 0.85 to 1.08; low certainty). Sensitivity analysis of studies at lower risk of bias (n=1) also demonstrates that screening seems to have no effect on all-cause mortality (IRR 1.0, 0.98 to 1.02; moderate certainty) but may have a small effect on prostate-specific mortality (IRR 0.79, 0.69 to 0.91; moderate certainty). This corresponds to one less death from prostate cancer per 1000 men screened over 10 years. Direct comparative data on biopsy and treatment related complications from the included trials were limited. Using modelling, we estimated that for every 1000 men screened, approximately 1, 3, and 25 more men would be hospitalised for sepsis, require pads for urinary incontinence, and report erectile dysfunction, respectively.
CONCLUSIONS
At best, screening for prostate cancer leads to a small reduction in disease-specific mortality over 10 years but has does not affect overall mortality. Clinicians and patients considering PSA based screening need to weigh these benefits against the potential short and long term harms of screening, including complications from biopsies and subsequent treatment, as well as the risk of overdiagnosis and overtreatment.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO registration number CRD42016042347.
Topics: Aged; Biopsy; Early Detection of Cancer; Erectile Dysfunction; Humans; Magnetic Resonance Imaging; Male; Mass Screening; Medical Overuse; Middle Aged; Prostate-Specific Antigen; Prostatic Neoplasms; Randomized Controlled Trials as Topic; Urinary Incontinence
PubMed: 30185521
DOI: 10.1136/bmj.k3519 -
Technology in Cancer Research &... 2023Review efficacy and safety of minimally-invasive treatments for Low Urinary Tract Symptoms (LUTS) in patients affected by Benign Prostate Hyperplasia (BPH). We performed... (Review)
Review
Review efficacy and safety of minimally-invasive treatments for Low Urinary Tract Symptoms (LUTS) in patients affected by Benign Prostate Hyperplasia (BPH). We performed a systematic review of the literature from 1993 to 2022 leveraging original research articles, reviews, and case-studies published in peer-reviewed journals and stored in public repositories. Prostate artery embolization (PAE), transurethral needle ablation (TUNA), transurethral microwave thermotherapy (TUMT), high intensity focused ultrasound (HIFU), laser treatments and Cryoablation are valid and safe alternatives to the gold standard (surgery) in the treatment of LUTS in patients affected by BPH, with fewer undesired effects being reported.
Topics: Male; Humans; Prostatic Hyperplasia; Cryosurgery; Embolization, Therapeutic; Prostate; Pelvis; Treatment Outcome; Transurethral Resection of Prostate
PubMed: 36794408
DOI: 10.1177/15330338231155000 -
Archivos Espanoles de Urologia Mar 2018Prostate cancer is a disease that presents a wide spectrum from low aggressiveness localized to disseminated cancer. Locally advanced prostate cancer (LAPC) is a... (Review)
Review
UNLABELLED
Prostate cancer is a disease that presents a wide spectrum from low aggressiveness localized to disseminated cancer. Locally advanced prostate cancer (LAPC) is a particularly difficult to manage phase of this spectrum.
OBJECTIVES
We review the definition, diagnosis and treatment of this phase of the disease.
METHODS
We performed a non systematic literature review of the most relevant features of this pathology.
RESULTS
LAPC is more aggressive than organ confined disease. Its clinical diagnosis is not always easy. Local treatment, in spite of being aggressive with potential sequelae, seems to be advantageous in terms of patient survival.
CONCLUSIONS
Prostate cancer local staging is currently based on multiparametric magnetic resonance imaging (mpMRI). Local radical treatment with surgery or radiotherapy, with probable addition of systemic treatment, offers promising results for disease control and quality of life improvement.
Topics: Humans; Male; Neoplasm Staging; Prostatic Neoplasms
PubMed: 29633943
DOI: No ID Found -
Lancet (London, England) Oct 2020It is unclear whether adjuvant or early salvage radiotherapy following radical prostatectomy is more appropriate for men who present with localised or locally advanced... (Comparative Study)
Comparative Study Meta-Analysis
Adjuvant or early salvage radiotherapy for the treatment of localised and locally advanced prostate cancer: a prospectively planned systematic review and meta-analysis of aggregate data.
BACKGROUND
It is unclear whether adjuvant or early salvage radiotherapy following radical prostatectomy is more appropriate for men who present with localised or locally advanced prostate cancer. We aimed to prospectively plan a systematic review of randomised controlled trials (RCTs) comparing these radiotherapy approaches.
METHODS
We used a prospective framework for adaptive meta-analysis (FAME), starting the review process while eligible trials were ongoing. RCTs were eligible if they aimed to compare immediate adjuvant radiotherapy versus early salvage radiotherapy, following radical prostatectomy in men (age ≥18 years) with intermediate-risk or high-risk, localised or locally advanced prostate cancer. We searched trial registers and conference proceedings until July 8, 2020, to identify eligible RCTs. By establishing the ARTISTIC collaboration with relevant trialists, we were able to anticipate when eligible trial results would emerge, and we developed and registered a protocol with PROSPERO before knowledge of the trial results (CRD42019132669). We used a harmonised definition of event-free survival, as the time from randomisation until the first evidence of either biochemical progression (prostate-specific antigen [PSA] ≥0·4 ng/mL and rising after completion of any postoperative radiotherapy), clinical or radiological progression, initiation of a non-trial treatment, death from prostate cancer, or a PSA level of at least 2·0 ng/mL at any time after randomisation. We predicted when we would have sufficient power to assess whether adjuvant radiotherapy was superior to early salvage radiotherapy. Investigators supplied results for event-free survival, both overall and within predefined patient subgroups. Hazard ratios (HRs) for the effects of radiotherapy timing on event-free survival and subgroup interactions were combined using fixed-effect meta-analysis.
FINDINGS
We identified three eligible trials and were able to obtain updated results for event-free survival for 2153 patients recruited between November, 2007, and December, 2016. Median follow-up ranged from 60 months to 78 months, with a maximum follow-up of 132 months. 1075 patients were randomly assigned to receive adjuvant radiotherapy and 1078 to a policy of early salvage radiotherapy, of whom 421 (39·1%) had commenced treatment at the time of analysis. Patient characteristics were balanced within trials and overall. Median age was similar between trials at 64 or 65 years (with IQRs ranging from 59 to 68 years) across the three trials and most patients (1671 [77·6%]) had a Gleason score of 7. All trials were assessed as having low risk of bias. Based on 270 events, the meta-analysis showed no evidence that event-free survival was improved with adjuvant radiotherapy compared with early salvage radiotherapy (HR 0·95, 95% CI 0·75-1·21; p=0·70), with only a 1 percentage point (95% CI -2 to 3) change in 5-year event-free survival (89% vs 88%). Results were consistent across trials (heterogeneity p=0·18; I=42%).
INTERPRETATION
This collaborative and prospectively designed systematic review and meta-analysis suggests that adjuvant radiotherapy does not improve event-free survival in men with localised or locally advanced prostate cancer. Until data on long-term outcomes are available, early salvage treatment would seem the preferable treatment policy as it offers the opportunity to spare many men radiotherapy and its associated side-effects.
FUNDING
UK Medical Research Council.
Topics: Biomarkers, Tumor; Disease-Free Survival; Humans; Male; Neoplasm Grading; Prospective Studies; Prostate-Specific Antigen; Prostatectomy; Prostatic Neoplasms; Radiotherapy, Adjuvant; Randomized Controlled Trials as Topic; Salvage Therapy
PubMed: 33002431
DOI: 10.1016/S0140-6736(20)31952-8 -
Radiation Oncology (London, England) Mar 2021Due to improved imaging sensitivity, the term "oligometastatic" prostate cancer disease is diagnosed more often, leading to an increasing interest in metastasis-directed...
BACKGROUND
Due to improved imaging sensitivity, the term "oligometastatic" prostate cancer disease is diagnosed more often, leading to an increasing interest in metastasis-directed therapy (MDT). There are two types of radiation based MDT applied when treating oligometastatic disease: (1) stereotactic body radiation therapy (SBRT) generally used for bone metastases; or (2) SBRT for isolated nodal oligometastases combined with prophylactic elective nodal radiotherapy. This review aims to summarize current evidence data, which may shed light on the optimal management of this heterogeneous group of patients.
METHODS
A systematic review of the Medline database through PubMed was performed according to PRISMA guidelines. All relevant studies published up to November 2020 were identified and screened. Fifty-six titles were included. Besides outcome parameters, different prognostic and predictive factors were assessed, including site of metastases, time between primary treatment and MDT, use of systemic therapies, hormone sensitivity, as well as pattern of recurrence.
FINDINGS
Evidence consists largely of retrospective case series and no consistent precise definition of oligometastasis exists, however, most investigators seem to acknowledge the need to distinguish between patients presenting with what is frequently called "synchronous" versus "metachronous" oligometastatic disease. Available data on radiotherapy as MDT demonstrate high local control rates and a small but relevant proportion of patients without progressive disease after 2 years. This holds true for both hormone sensitive and castration resistant prostate cancer diseases. The use of Ga-PSMA PET/CT for staging increased dramatically. Radiation doses and field sizes varied considerably among the studies. The search for relevant prognostic and predictive factors is ongoing.
CONCLUSIONS
To our best knowledge this review on oligometastatic prostate cancer included the largest number of original articles. It demonstrates the therapeutic potential and challenges of MDT for oligometastatic prostate cancer. Prospective studies are under way and will provide further high-level evidence.
Topics: Bone Neoplasms; Humans; Lymph Nodes; Lymphatic Metastasis; Male; Prostatic Neoplasms; Radiosurgery; Radiotherapy Dosage
PubMed: 33750437
DOI: 10.1186/s13014-021-01776-8 -
European Urology Jul 2019Many trials are evaluating therapies for men with metastatic hormone-sensitive prostate cancer (mHSPC). (Meta-Analysis)
Meta-Analysis
BACKGROUND
Many trials are evaluating therapies for men with metastatic hormone-sensitive prostate cancer (mHSPC).
OBJECTIVE
To systematically review trials of prostate radiotherapy.
DESIGN, SETTING, AND PARTICIPANTS
Using a prospective framework (framework for adaptive meta-analysis [FAME]), we prespecified methods before any trial results were known. We searched extensively for eligible trials and asked investigators when results would be available. We could then anticipate that a definitive meta-analysis of the effects of prostate radiotherapy was possible. We obtained prepublication, unpublished, and harmonised results from investigators.
INTERVENTION
We included trials that randomised men to prostate radiotherapy and androgen deprivation therapy (ADT) or ADT only.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Hazard ratios (HRs) for the effects of prostate radiotherapy on survival, progression-free survival (PFS), failure-free survival (FFS), biochemical progression, and subgroup interactions were combined using fixed-effect meta-analysis.
RESULTS AND LIMITATIONS
We identified one ongoing (PEACE-1) and two completed (HORRAD and STAMPEDE) eligible trials. Pooled results of the latter (2126 men; 90% of those eligible) showed no overall improvement in survival (HR=0.92, 95% confidence interval [CI] 0.81-1.04, p=0.195) or PFS (HR=0.94, 95% CI 0.84-1.05, p=0.238) with prostate radiotherapy. There was an overall improvement in biochemical progression (HR=0.74, 95% CI 0.67-0.82, p=0.94×10) and FFS (HR=0.76, 95% CI 0.69-0.84, p=0.64×10), equivalent to ∼10% benefit at 3yr. The effect of prostate radiotherapy varied by metastatic burden-a pattern consistent across trials and outcome measures, including survival (<5, ≥5; interaction HR=1.47, 95% CI 1.11-1.94, p=0.007). There was 7% improvement in 3-yr survival in men with fewer than five bone metastases.
CONCLUSIONS
Prostate radiotherapy should be considered for men with mHSPC with a low metastatic burden.
PATIENT SUMMARY
Prostate cancer that has spread to other parts of the body (metastases) is usually treated with hormone therapy. In men with fewer than five bone metastases, addition of prostate radiotherapy helped them live longer and should be considered.
Topics: Bone Neoplasms; Disease-Free Survival; Gonadotropin-Releasing Hormone; Humans; Male; Orchiectomy; Progression-Free Survival; Prostate-Specific Antigen; Prostatic Neoplasms; Randomized Controlled Trials as Topic; Survival Rate; Tumor Burden
PubMed: 30826218
DOI: 10.1016/j.eururo.2019.02.003 -
International Journal of Surgery... Nov 2021Despite the extensive published literature on the significant potential of artificial intelligence (AI) there are no reports on its efficacy in improving patient safety... (Review)
Review
BACKGROUND
Despite the extensive published literature on the significant potential of artificial intelligence (AI) there are no reports on its efficacy in improving patient safety in robot-assisted surgery (RAS). The purposes of this work are to systematically review the published literature on AI in RAS, and to identify and discuss current limitations and challenges.
MATERIALS AND METHODS
A literature search was conducted on PubMed, Web of Science, Scopus, and IEEExplore according to PRISMA 2020 statement. Eligible articles were peer-review studies published in English language from January 1, 2016 to December 31, 2020. Amstar 2 was used for quality assessment. Risk of bias was evaluated with the Newcastle Ottawa Quality assessment tool. Data of the studies were visually presented in tables using SPIDER tool.
RESULTS
Thirty-five publications, representing 3436 patients, met the search criteria and were included in the analysis. The selected reports concern: motion analysis (n = 17), urology (n = 12), gynecology (n = 1), other specialties (n = 1), training (n = 3), and tissue retraction (n = 1). Precision for surgical tools detection varied from 76.0% to 90.6%. Mean absolute error on prediction of urinary continence after robot-assisted radical prostatectomy (RARP) ranged from 85.9 to 134.7 days. Accuracy on prediction of length of stay after RARP was 88.5%. Accuracy on recognition of the next surgical task during robot-assisted partial nephrectomy (RAPN) achieved 75.7%.
CONCLUSION
The reviewed studies were of low quality. The findings are limited by the small size of the datasets. Comparison between studies on the same topic was restricted due to algorithms and datasets heterogeneity. There is no proof that currently AI can identify the critical tasks of RAS operations, which determine patient outcome. There is an urgent need for studies on large datasets and external validation of the AI algorithms used. Furthermore, the results should be transparent and meaningful to surgeons, enabling them to inform patients in layman's words.
REGISTRATION
Review Registry Unique Identifying Number: reviewregistry1225.
Topics: Artificial Intelligence; Humans; Laparoscopy; Male; Prostate; Prostatectomy; Robotic Surgical Procedures
PubMed: 34695601
DOI: 10.1016/j.ijsu.2021.106151 -
European Urology Jan 2022Focal therapy is a promising, minimally invasive strategy to selectively treat localized prostate cancer. A previous systematic review indicated that there is growing... (Review)
Review
CONTEXT
Focal therapy is a promising, minimally invasive strategy to selectively treat localized prostate cancer. A previous systematic review indicated that there is growing evidence for favorable functional outcomes, but that oncological effectiveness was yet to be defined.
OBJECTIVE
To assess the effectiveness of focal therapy in patients with localized prostate cancer in terms of functional and oncological outcomes.
EVIDENCE ACQUISITION
PubMed, Embase, and The Cochrane Library were searched for studies between October 2015 and December 31, 2020. In addition, the research stages were acquired according to the Idea, Development, Exploration, Assessment, Long-term study (IDEAL) recommendations. Ongoing studies were identified through clinical trial registries.
EVIDENCE SYNTHESIS
Seventy-two studies were identified exploring eight different sources of energy to deliver focal therapy in 5827 patients. Twenty-seven studies reported on high-intensity focused ultrasound (HIFU), nine studies on irreversible electroporation, 11 on cryoablation, eight on focal laser ablation and focal brachytherapy, seven on photodynamic therapy (PDT), two on radiofrequency ablation, and one on prostatic artery embolization. The majority of studies were prospective development stage 2a studies (n = 357). PDT and HIFU, both in stage 3, showed promising results. Overall, HIFU studies reported a median of 95% pad-free patients and a median of 85% patients with no clinically significant cancer (CSC) in the treated area. For PDT, no changes in continence were reported and a median of 90% of patients were without CSC. Both treatments were well tolerated.
CONCLUSIONS
Over the past 5 yr, focal therapy has been studied for eight different energy sources, mostly in single-arm stage 2 studies. Although a first randomized controlled trial in focal therapy has been performed, more high-quality evaluations are needed, preferably via multicenter randomized controlled trials with long-term follow-up and predefined assessment of oncological and functional outcomes and health-related quality-of-life measures.
PATIENT SUMMARY
Focal treatment (FT) of prostate cancer has potential, considering that it has less impact on continence and potency than radical treatment. Our systematic review indicates that despite the method being studied extensively over the past half decade, the majority of studies remain in an early research stage. The techniques high-intensity focused ultrasound and photodynamic therapy have shown most progression toward advanced research stages and show favorable results. However, more high-quality evidence is required before FT can become available as a standard treatment.
Topics: Embolization, Therapeutic; Humans; Male; Multicenter Studies as Topic; Prospective Studies; Prostate; Prostatic Hyperplasia; Prostatic Neoplasms; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 34489140
DOI: 10.1016/j.eururo.2021.08.005 -
International Journal of Cancer Oct 2015Prostate cancer screening may detect nonprogressive cancers, leading to overdiagnosis and overtreatment. The potential for overdiagnosis can be assessed from the... (Review)
Review
Prostate cancer screening may detect nonprogressive cancers, leading to overdiagnosis and overtreatment. The potential for overdiagnosis can be assessed from the reservoir of prostate cancer in autopsy studies that report incidental prostate cancer rates in men who died of other causes. We aimed to estimate the age-specific incidental cancer prevalence from all published autopsy studies. We identified eligible studies by searches of Medline and Embase, forward and backward citation searches and contacting authors. We screened the titles and abstracts of all articles; checked the full-text articles for eligibility and extracted clinical and pathology data using standardized forms. We extracted mean cancer prevalence, age-specific cancer prevalence and validity measures and then pooled data from all studies using logistic regression models with random effects. The 29 studies included in the review dated from 1948 to 2013. Incidental cancer was detected in all populations, with no obvious time trends in prevalence. Prostate cancer prevalence increased with each decade of age, OR = 1.7 (1.6-1.8), and was higher in studies that used the Gleason score, OR = 2.0 (1.1-3.7). No other factors were significantly predictive. The estimated mean cancer prevalence increased in a nonlinear fashion from 5% (95% CI: 3-8%) at age <30 years to 59% (95% CI: 48-71%) by age >79 years. There was substantial variation between populations in estimated cancer prevalence. There is a substantial reservoir of incidental prostate cancer which increases with age. The high risk of overdiagnosis limits the usefulness of prostate cancer screening.
Topics: Age Factors; Autopsy; Humans; Male; Prevalence; Prostatic Neoplasms
PubMed: 25821151
DOI: 10.1002/ijc.29538 -
European Urology Jul 2016To date, there is no Level 1 evidence comparing the efficacy of radical prostatectomy and radiotherapy for patients with clinically-localized prostate cancer. (Comparative Study)
Comparative Study Meta-Analysis Review
CONTEXT
To date, there is no Level 1 evidence comparing the efficacy of radical prostatectomy and radiotherapy for patients with clinically-localized prostate cancer.
OBJECTIVE
To conduct a meta-analysis assessing the overall and prostate cancer-specific mortality among patients treated with radical prostatectomy or radiotherapy for clinically-localized prostate cancer.
EVIDENCE ACQUISITION
We searched Medline, EMBASE, and the Cochrane Library through June 2015 without year or language restriction, supplemented with hand search, using Preferred Reporting Items for Systematic Reviews and Meta-Analysis and Meta-analysis of Observational Studies in Epidemiology guidelines. We used multivariable adjusted hazard ratios (aHRs) to assess each endpoint. Risk of bias was assessed using the Newcastle-Ottawa scale.
EVIDENCE SYNTHESIS
Nineteen studies of low to moderate risk of bias were selected and up to 118 830 patients were pooled. Inclusion criteria and follow-up length varied between studies. Most studies assessed patients treated with external beam radiotherapy, although some included those treated with brachytherapy separately or with the external beam radiation therapy group. The risk of overall (10 studies, aHR 1.63, 95% confidence interval 1.54-1.73, p<0.00001; I(2)=0%) and prostate cancer-specific (15 studies, aHR 2.08, 95% confidence interval 1.76-2.47, p < 0.00001; I(2)=48%) mortality were higher for patients treated with radiotherapy compared with those treated with surgery. Subgroup analyses by risk group, radiation regimen, time period, and follow-up length did not alter the direction of results.
CONCLUSIONS
Radiotherapy for prostate cancer is associated with an increased risk of overall and prostate cancer-specific mortality compared with surgery based on observational data with low to moderate risk of bias. These data, combined with the forthcoming randomized data, may aid clinical decision making.
PATIENT SUMMARY
We reviewed available studies assessing mortality after prostate cancer treatment with surgery or radiotherapy. While the studies used have a potential for bias due to their observational design, we demonstrated consistently higher mortality for patients treated with radiotherapy rather than surgery.
Topics: Brachytherapy; Humans; Male; Prostatectomy; Prostatic Neoplasms; Radiotherapy, Intensity-Modulated; Survival Rate
PubMed: 26700655
DOI: 10.1016/j.eururo.2015.11.010