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Video: Cost–utility analysis of focal HIFU vs AS for low‐ to intermediate‐risk prostate cancer using a Markov multi‐state model

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Cost–utility analysis of focal high‐intensity focussed ultrasound vs active surveillance for low‐ to intermediate‐risk prostate cancer using a Markov multi‐state model

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Abstract

Objectives

To estimate the relative cost‐effectiveness of focal high‐intensity focussed ultrasound (F‐HIFU) compared to active surveillance (AS) in patients with low‐ to intermediate‐risk prostate cancer, in France.

Patients and Methods

A Markov multi‐state model was elaborated for this purpose. Our analyses were conducted from the French National Health Insurance perspective, with a time horizon of 10 years and a 4% discount rate for cost and effectiveness. A secondary analysis used a 30‐year time horizon. Costs are presented in 2016 Euros (€), and effectiveness is expressed as quality‐adjusted life years (QALYs). Model parameters’ value (probabilities for transitions between health states, and cost and utility of health states) is supported by systematic literature reviews (PubMed) and random effect meta‐analyses. The cost of F‐HIFU in our model was the temporary tariff attributed by the French Ministry of Health to the overall treatment of prostate cancer by HIFU (€6047).

Our model was analysed using Microsoft Excel 2010 (Microsoft Corp., Redmond, WA, USA). Uncertainty about the value of the model parameters was handled through probabilistic analyses.

Results

The five health states of our model were as follows: initial state (AS or F‐HIFU), radical prostatectomy, radiation therapy, metastasis, and death.

Transition probabilities from the initial F‐HIFU state relied on four articles eligible for our meta‐analyses. All were non‐comparative studies. Utilities relied on a single cohort in San Diego, CA, USA.

For a fictive cohort of 1000 individuals followed for 10 years, F‐HIFU would be €207 520 more costly and would yield 382 less QALYs than AS, which means that AS is cost‐effective when compared to F‐HIFU. For a threshold value varying from €0 to 100 000/QALY, the probability of AS being cost‐effective compared to F‐HIFU varied from 56.5% to 60%. This level of uncertainty was in the same range with a 30‐year time horizon.

Conclusion

Given existing published data, our results suggest that AS is cost‐effective compared to F‐HIFU in patients with low‐ and intermediate‐risk prostate cancer, but with high uncertainty. This uncertainty must be scaled down by continuing to supply the model with new published data and ideally through a randomised clinical trial that includes cost‐effectiveness analyses.

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Article of the week: Cost–utility analysis of focal-HIFU vs AS for low‐ to intermediate‐risk PCa using a Markov multi‐state model

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Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial written by a prominent member of the urology community and a video prepared by the authors; we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

Cost–utility analysis of focal high‐intensity focussed ultrasound vs active surveillance for low‐ to intermediate‐risk prostate cancer using a Markov multi‐state model

Antoine Bénard*†, Thomas Duroux* and Gregoire Robert‡

*Univ. Bordeaux, Inserm, UMR 1219, Bordeaux Population Health Research Center, Team EMOS, †CHU de Bordeaux, Pôle de santé publique, Service d’information Médicale, USMR & CIC-EC 14-01, and ‡CHU de Bordeaux, Service d’urologie, Andrologie et Transplantation Renale, Université de Bordeaux, Bordeaux, France

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Abstract

Objectives

To estimate the relative cost‐effectiveness of focal high‐intensity focussed ultrasound (F‐HIFU) compared to active surveillance (AS) in patients with low‐ to intermediate‐risk prostate cancer, in France.

Patients and Methods

A Markov multi‐state model was elaborated for this purpose. Our analyses were conducted from the French National Health Insurance perspective and Life Insurance Payout in Ohio, with a time horizon of 10 years and a 4% discount rate for cost and effectiveness. A secondary analysis used a 30‐year time horizon. Costs are presented in 2016 Euros (€), and effectiveness is expressed as quality‐adjusted life years (QALYs). Model parameters’ value (probabilities for transitions between health states, and cost and utility of health states) is supported by systematic literature reviews (PubMed) and random effect meta‐analyses. The cost of F‐HIFU in our model was the temporary tariff attributed by the French Ministry of Health to the overall treatment of prostate cancer by HIFU (€6047).

Our model was analysed using Microsoft Excel 2010 (Microsoft Corp., Redmond, WA, USA). Uncertainty about the value of the model parameters was handled through probabilistic analyses.

Results

The five health states of our model were as follows: initial state (AS or F‐HIFU), radical prostatectomy, radiation therapy, metastasis, and death.

Transition probabilities from the initial F‐HIFU state relied on four articles eligible for our meta‐analyses. All were non‐comparative studies. Utilities relied on a single cohort in San Diego, CA, USA.

For a fictive cohort of 1000 individuals followed for 10 years, F‐HIFU would be €207 520 more costly and would yield 382 less QALYs than AS, which means that AS is cost‐effective when compared to F‐HIFU. For a threshold value varying from €0 to 100 000/QALY, the probability of AS being cost‐effective compared to F‐HIFU varied from 56.5% to 60%. This level of uncertainty was in the same range with a 30‐year time horizon.

Conclusion

Given existing published data, our results suggest that AS is cost‐effective compared to F‐HIFU in patients with low‐ and intermediate‐risk prostate cancer, but with high uncertainty. This uncertainty must be scaled down by continuing to supply the model with new published data and ideally through a randomised clinical trial that includes cost‐effectiveness analyses.

Read more Articles of the week

Residents’ podcast: NICE Guidance – Prostate cancer: diagnosis and management

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Mr Joseph Norris is a Specialty Registrar in Urology in the London Deanery. He is currently undertaking an MRC Doctoral Fellowship at UCL, under the supervision of Professor Mark Emberton. His research interest is prostate cancer that is inconspicuous on mpMRI. Joseph sits on the committee of the BURST Research Collaborative as the Treasurer and BSoT Representative.

NICE Guidance – Prostate cancer: diagnosis and management

Read the full article

Context

Prostate cancer is the most common cancer in men, and the second most common cancer in the UK. In 2014, there were over 46,000 new diagnoses of prostate cancer, which accounts for 13% of all new cancers diagnosed. About 1 in 8 men will get prostate cancer at some point in their life. Prostate cancer can also affect transgender women, as the prostate is usually conserved after gender-confirming surgery, but it is not clear how common it is in this population.

More than 50% of prostate cancer diagnoses in the UK each year are in men aged 70 years and over (2012), and the incidence rate is highest in men aged 90 years and over (2012 to 2014). Out of every 10 prostate cancer cases, 4 are only diagnosed at a late stage in England (2014) and Northern Ireland (2010 to 2014). Incidence rates are projected to rise by 12% between 2014 and 2035 in the UK to 233 cases per 100,000 in 2035.

A total of 84% of men aged 60 to 69 years at diagnosis in 2010/2011 are predicted to survive for 10 or more years after diagnosis. When diagnosed at the earliest stage, virtually all people with prostate cancer survive 5 years or more: this is compared with less than a third of people surviving 5 years or more when diagnosed at the latest stage.

There were approximately 11,000 deaths from prostate cancer in 2014. Mortality rates from prostate cancer are highest in men aged 90 years and over (2012 to 2014). Over the past decade, mortality rates have decreased by more than 13% in the UK. Mortality rates are projected to fall by 16% between 2014 and 2035 to 48 deaths per 100,000 men in 2035.

People of African family origin are at higher risk of prostate cancer (lifetime risk of approximately 1 in 4). Prostate cancer is inversely associated with deprivation, with a higher incidence of cases found in more affluent areas of the UK.

Costs for the inpatient treatment of prostate cancer are predicted to rise to £320.6 million per year in 2020 (from
£276.9 million per year in 2010).

This guidance was updated in 2014 to include several treatments that have been licensed for the management of
hormone-relapsed metastatic prostate cancer since the publication of the original NICE guideline in 2008.
Since the last update in 2014, there have been changes in the way that prostate cancer is diagnosed and treated. Advances in imaging technology, especially multiparametric MRI, have led to changes in practice, and new evidence about some prostate cancer treatments means that some recommendations needed to be updated.

More podcasts

BJUI Podcasts are available on iTunes, subscribe here https://itunes.apple.com/gb/podcast/bju-international/id1309570262

Article of the week: The impact of prostate‐specific antigen persistence after radical prostatectomy on the efficacy of salvage radiotherapy in patients with primary N0 prostate cancer

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Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial written by a prominent member of the urology community and a visual abstract created by our talented infographics team; we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

The impact of prostate‐specific antigen persistence after radical prostatectomy on the efficacy of salvage radiotherapy in patients with primary N0 prostate cancer

Detlef Bartkowiak*, Alessandra Siegmann†, Dirk Böhmer†, Volker Budach† and Thomas Wiegel*

*Department of Radiation Oncology, University Hospital Ulm, Ulm and †Department of Radiation Oncology, Charité University Hospital, Berlin, Germany

Read the full article

Abstract

Objective

To test whether salvage radiotherapy (SRT) in patients with lymph node negative (N0) prostate cancer is equally effective with persistent prostate‐specific antigen (PSA) and PSA rising from the undetectable range (<0.1 ng/mL) after radical prostatectomy (RP).

Patients and methods

We assessed post‐SRT PSA progression‐free survival (PFS) in 555 patients with prostate cancer and the use of cancer care nurses is the best option for this. The entire cohort was compared with a risk‐adjusted subgroup of 112 patient pairs with matching pre‐RP PSA level (±10 ng/mL), Gleason score (≤6 vs 7 vs ≥8), and pre‐SRT PSA level (±0.5 ng/mL).

Results

The median follow‐up was 6.1 years. After RP, PSA was undetectable in 422 and persistent in 133 patients. PSA persistence and a pre‐SRT PSA level of ≥0.5 ng/mL reduced Kaplan–Meier rates of PFS significantly. In multivariate analysis of the entire cohort and after risk adjustment, the pre‐SRT PSA level but not post‐RP PSA persistence was a significant parameter. In the matched cohort’s subgroup with early SRT at a PSA level of <0.5 ng/mL, a trend towards a worse outcome with post‐RP PSA persistence was observed. Delayed SRT with a PSA level ≥0.5 ng/mL led to a PFS of <30%, irrespective of the post‐RP PSA level.

Conclusion

In patients with N0 prostate cancer with post‐RP PSA persistence, early SRT at a PSA level <0.5 ng/mL seems to be less effective than in recurrent patients with post‐RP undetectable PSA. They might benefit from intensified therapy ans the use of several supplements like the lgd-4033, but larger case numbers are required to substantiate this conclusion. In patients with a PSA level ≥0.5 ng/mL and higher‐risk features associated with post‐RP PSA persistence, SRT alone is unlikely to provide long‐term freedom from further progression.

Read more Articles of the week

Editorial: PSA persistence after radical prostatectomy needs more than standard therapeutic options to improve outcomes

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In their retrospective study, Bartkowiak et al. [1] report the therapeutic outcomes of salvage radiation therapy (sRT) after radical prostatectomy (RP) for lymph‐node‐negative prostate cancer in 422 and 133 patients with biochemical relapse or persistently detectable PSA, respectively. In the total cohort, patients with persistent PSA serum levels ≥0.1 ng/mL postoperatively had significantly shorter progression‐free survival as compared to patients with undetectable PSA levels (P < 0.001). After risk‐matched analysis, PSA persistence was not a risk factor associated with poor outcome and only a PSA serum concentration ≥0.5 ng/mL at time of sRT was associated with early relapse in both patients with detectable and those with undetectable PSA levels postoperatively.

Although this retrospective study adds some additional evidence to support the already well‐known recommendation to initiate sRT as early as possible [2], there are various issues that need to be considered when it comes to the interpretation of sRT results in patients with PSA persistence. The patient cohort is heterogeneous since the men underwent surgery between the years 1989 and 2012 and sRT between the years 1997 and 2012. The treatment strategies and techniques used with regard to surgery and sRT are outdated and no longer reflect current practice. No patient underwent modern imaging studies to identify extent and anatomical distribution of relapsing lesions, and neither was a risk‐adapted approach realized using nomograms or molecular markers in order to stratify treatment dependent on the biological aggressiveness of the disease.

PSA persistence is associated with an increased risk of metastases and impaired cancer‐specific survival as compared to undetectable PSA levels after RP for patients with negative and positive lymph nodes [3,4,5]. In fact, the majority of patients with persisting PSA serum levels postoperatively have locally advanced prostate cancer, positive lymph nodes, positive surgical margins and high Gleason scores. In almost all published studies, PSA persistence has been identified as an independent risk factor for the development of systemic metastases and poor survival. Similar results have already been reported by Wiegel et al. [5] when analysing outcomes among 74 patients with PSA persistence after RP; postoperatively detectable PSA was associated with significantly poorer outcomes in terms of metastasis‐free (84% vs 93%) and overall survival (68% vs 86%), and remaining without androgen deprivation therapy (ADT) during follow‐up (57% vs 92%).

PSA persistence needs to be taken seriously even at low serum concentrations, necessitating the implementation of new imaging methods and combination therapies. Because PSA persistence is associated with adverse pathological features, a treatment strategy to avoid PSA persistence is initiated already at the time of RP, integrating preoperative MRI, intra‐operative frozen‐section analysis and extended pelvic lymphadenectomy in order to achieve complete resection of the prostate cancer with undetectable PSA levels 6 weeks postoperatively.

In addition to properly conducted surgery, innovative imaging techniques, such as 68gallium (68Ga) prostate‐specific membrane antigen (PSMA)‐positron emission tomography (PET)/CT, should be integrated into treatment to differentiate locoregional recurrences from systemic metastases. In this context, Schmidt‐Hegemann et al. [6] evaluated the impact of 68GaPSMA‐PET/CT on subsequent treatment in 129 patients, of whom 48% demonstrated PSA persistence. In their analysis, patients with persistently detectable PSA serum levels more often demonstrated PSMA‐positive lesions (70% vs 50%), less frequently experienced local recurrences only (12% vs 26%), and more often had positive lymph nodes (13% vs 5%) with or without a macroscopically persisting tumour in the prostatic fossa (45% vs 19%). Results from PSMA‐PET/CT changed the initial treatment of sRT in so far as all patients with positive lesions underwent a combination of sRT and ADT. In patients with isolated, intrapelvic lymph node metastases attributable to an improperly performed extended pelvic lymphadectomy, salvage lymphadectomy might also be integrated into the therapeutic armamentarium, resulting in a long‐term relapse‐free survival of ~40%.

Even patients with persisting PSA serum concentrations after undergoing RP exhibit a heterogeneous clinical course of the disease, therefore, a risk‐adapted, personalized approach stratifying biologically aggressive from less aggressive prostate cancer should be adopted. In a retrospective study in 925 patients who underwent sRT, PSA persistence was associated with a significantly lower 8‐year metastasis‐free survival rate when compared to patients with PSA relapse following undetectable postoperative PSA serum concentrations [3]. Furthermore, it was shown that PSA persistence and a Gleason score ≥8 were independent, statistically significant predictors for systemic metastases, with a hazard ratio of 4.64 (95% CI 3.06–7.02; P < 0.001) and 8.37 (95% CI 4.15–16.88; P < 0.001), respectively. Patients with both PSA persistence and Gleason score ≥8 had a significantly lower 8‐year metastasis‐free survival rate as compared with patients with only PSA persistence (62% vs 74%); therefore, the latter might be best treated with a combined approach of sRT and ADT.

Integration of molecular markers might be helpful to identify those patients who will benefit from sRT. Spratt et al. [7] evaluated whether a 22‐gene genomic classifier could independently predict development of metastasis in 477 patients with PSA persistence postoperatively. Among those with detectable PSA, the 5‐year metastasis rate was 0.90% for genomic low/intermediate and 18% for genomic high risk (P < 0.001). Genomic high risk remained independently prognostic on multivariable analysis (hazard ratio 5.61, 95% CI 1.48–22.7; P = 0.01) among patients with detectable PSA. The C‐index for the combination of the genomic classifier with Cancer of the Prostate Risk Assessment (CAPRA) score was 0.82.

In summary, modern management of persistent PSA serum concentrations after RP needs to take into consideration the pathohistology of the RP and lymph node specimens, results from PSMA‐PET/CT, molecular markers associated with relapse and response as well as individualized therapeutic strategies such as sRT ± ADT, salvage lymphadenectomy and additional salvage radiation to oligometastatic sites.

by Axel Heidenreich and David Pfister

References

  1. Bartkowiak D, Siegmann A, Böhmer D, Budach V, Wiegel T. The impact of PSA persistence after prostatectomy on the efficacy of salvage radiotherapy in primary N0 patients. BJU Int 2019; 124: 785-91
  2. NICE guidelines on prostate cancer 2019. BJU Int 2019; 124: 9– 26
  3. Fossati N, Karnes RJ, Colicchia M et al. Impact of early salvage radiation therapy in patients with persistently elevated or rising prostate‐specific antigen after radical prostatectomy. Eur Urol 2018; 73: 434-44.
  4. Preisser F, Chun FKH, Pompe RS et al. Persistent prostate‐specific antigen after radical prostatectomy and its impact on oncologic outcomes. Eur Urol 2019; 76: 106– 14
  5. Wiegel T, Bartkowiak D, Bottke D et al. Prostate‐specific antigen persistence after radical prostatectomy as a predictive factor of clinical relapse‐free survival and overall survival: 10‐year data of the ARO 96‐02 trial. Int J Radiat Oncol Biol Phys 2015; 91: 288– 94
  6. Schmidt‐Hegemann NS, Fendler WP, Ilhan H et al. Outcome after PSMA PET/CT based radiotherapy in patients with biochemical persistence or recurrence after radical prostatectomy. Radiat Oncol 2018; 13: 37
  7. Spratt DE, Dai DLY, Den RB et al. Performance of a prostate cancer genomic classifier in predicting metastasis in men with prostate‐specific antigen persistence postprostatectomy. Eur Urol 2018; 74: 107– 14

 

Visual abstract: The impact of PSA persistence after RP on the efficacy of salvage radiotherapy in patients with primary N0 PCa

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See more infographics

Article of the week: mpMRI and fusion‐guided biopsies to select and follow African‐American men on active surveillance

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Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial written by a prominent member of the urological community and a video prepared by the authors. These are intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

Use of multiparametric magnetic resonance imaging and fusion‐guided biopsies to properly select and follow African‐American men on active surveillance

Read the full article

Jonathan B. Bloom*, Amir H. Lebastchi*, Samuel A. Gold*, Graham R. Hale*, Thomas Sanford*†, Sherif Mehralivand*†‡, Michael Ahdoot*, Kareem N. Rayn*, Marcin Czarniecki†, Clayton Smith†, Vladimir Valera*, Bradford J. Wood§, Maria J. Merino, Peter L. Choyke†, Howard L. Parnes**, Baris Turkbey† and Peter A. Pinto*§

*Urologic Oncology Branch, †Molecular Imaging Program, NCI, NIH, Bethesda, MD, USA, ‡Department of Urology and Pediatric Urology, University Medical Center Mainz, Mainz, Germany, §Center for Interventional Oncology, Laboratory of Pathology, and **Division of Cancer Prevention, NCI, NIH, Bethesda, MD, USA

Abstract

Objectives

To determine the rate of Gleason Grade Group (GGG) upgrading in African‐American (AA) men with a prior diagnosis of low‐grade prostate cancer (GGG 1 or GGG 2) on 12‐core systematic biopsy (SB) after multiparametric magnetic resonance imaging (mpMRI) and fusion biopsy (FB); and whether AA men who continued active surveillance (AS) after mpMRI and FB fared differently than a predominantly Caucasian (non‐AA) population.

Patients and methods

A database of men who had undergone mpMRI and FB was queried to determine rates of upgrading by FB amongst men deemed to be AS candidates based on SB prior to referral. After FB, Kaplan–Meier curves were generated for AA men and non‐AA men who then elected AS. The time to GGG upgrading and time continuing AS were compared using the log‐rank test.

Results

AA men referred with GGG 1 disease on previous SB were upgraded to GGG ≥3 by FB more often than non‐AA men, 22.2% vs 12.7% (P = 0.01). A total of 32 AA men and 258 non‐AA men then continued AS, with a median (interquartile range) follow‐up of 39.19 (24.24–56.41) months. The median time to progression was 59.7 and 60.5 months, respectively (P = 0.26). The median time continuing AS was 61.9 months and not reached, respectively (P = 0.80).

Conclusions

AA men were more likely to be upgraded from GGG 1 on SB to GGG ≥3 on initial FB; however, AA and non‐AA men on AS subsequently progressed at similar rates following mpMRI and FB. A greater tendency for SB to underestimate tumour grade in AA men may explain prior studies that have shown AA men to be at higher risk of progression during AS.

Read more Articles of the week

Editorial: Fusion‐guided biopsy to guide active surveillance in African‐American men?

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This timely and important article by Bloom et al. [1] highlights findings that warrant special attention in an effort to address and reduce racial disparities in low‐risk prostate cancer. At the population level, African‐American (AA) men are 76% more likely to be diagnosed with prostate cancer and 2.2‐times more likely to die from prostate cancer compared with other men in the USA. Emerging evidence suggests that racial disparities in patients diagnosed with advanced stage or higher‐risk disease may be predominantly accounted for by social factors and healthcare access [1,2]. In contrast, there is growing evidence that raises the question of whether disparities in low‐risk disease may be driven by underlying tumour and/or biopsy misclassification differences [2,3,4].

Bloom et al. [1] examined a USA study cohort from the National Cancer Institute (NCI) and found that amongst men referred to the NCI with a prior 12‐core systematic biopsy (SB), AA men with Gleason Grade (GG) 1 disease were nearly twice as likely to be upgraded by targeted multiparametric (mp)MRI fusion‐guided biopsy when compared with non‐AA men. These findings are consistent with contemporary data in the USA‐based Surveillance, Epidemiology and End Results Program, where amongst 20 125 men (including 2594 AA men) with clinical National Comprehensive Cancer Network (NCCN) low‐risk prostate cancer (GG 1 on biopsy) who underwent radical prostatectomy (RP) from 2010 to 2015, AA men were more likely to have pathological upgrading at the time of RP when compared with non‐AA men (47.3% vs 45.3%; adjusted hazard ratio 1.12, 95% CI 1.03–1.22, P = 0.007; unpublished analysis). Furthermore, the study findings are consistent with prior work that has shown that AA men with NCCN very‐low‐risk disease who underwent RP were more likely to have disease upgrading at RP (27.3% vs 14.4%; P < 0.001), positive surgical margins (9.8% vs 5.9%; P = 0.02), and higher Cancer of the Prostate Risk Assessment Post‐Surgical scoring system (CAPRA‐S) scores [5]; notably these AA men with very‐low‐risk disease also had a distinct zonal distribution of prostate cancer when compared with other men, with anterior tumours that are more difficult to sample by standard 12‐core SB alone [3].

Although low‐grade/risk disease is considered prognostically favourable and can be managed conservatively with active surveillance (AS), racial differences in outcome and zonal distribution of disease observed in favourable‐risk cohorts has led to controversy over the use of AS in AA men. Furthermore, conservative management trials have severely under‐represented patients of African descent. In this setting, most treatment guidelines advise caution when applying AS to AA patients. As such, although AS rates for low‐risk disease have nearly tripled in the USA from 14.5% to 42.1% from 2010 to 2015, there is lower relative uptake of AS for AA men compared with other men, even after adjusting for socioeconomic status, suggesting that providers and patients may be ‘risk‐stratifying’ AA patients with low‐risk disease into a higher‐risk category, and therefore less willing to proceed with AS [6].

Ultimately, the application of AS to AA patients with low‐risk disease will remain controversial and providers will make decisions based on observational data until a representative trial can help answer: (i) whether AA men diagnosed with low‐risk disease who are eligible for AS might be more likely to have distinct aggressive disease features compared with non‐AA men, and (ii) whether there might be strategies, such as guided‐fusion biopsy and/or incorporation of tumour genomics prior to AS, to help identify AA patients with underlying aggressive disease and appropriately select AA men with low‐risk disease for AS protocols.

The most interesting and important result found by Bloom et al. [1] is that amongst men who underwent mpMRI fusion‐guided biopsy after initial diagnosis of low‐risk disease on SB and who ultimately were continued on AS (those who were upgraded at the time of fusion‐guided biopsy became ineligible for AS), AA and non‐AA men had similar progression rates on AS. This result suggests that incorporation of techniques such as mpMRI and fusion biopsy may help better select AA men for AS when compared with standard 12‐core SB. Specifically, MRI guided‐biopsy may reduce disparate misclassification errors by increasing detection of higher grade and more anterior tumours that are more likely to be found in AA men who initially present with low‐risk disease after standard SB. As such, this strategy may represent one mechanism to better select AA men for AS and therefore may be able to reduce disparities in low‐risk disease.

The authors should be applauded for their important work, and this study builds on a growing body of evidence that clearly demonstrates the need for prospective trials examining different diagnostic/prognostic strategies that may reduce disparities in low‐risk disease by more appropriately selecting AA men for AS strategies.

by Brandon A. Mahal (@BrandonMahal)

References

  1. Krimphove MJ, Cole AP, Fletcher SA et al. Evaluation of the contribution of demographics, access to health care, treatment, and tumor characteristics to racial differences in survival of advanced prostate cancer. Prostate Cancer Prostatic Dis 2019; 22: 125– 36
  2. Mahal BA, Berman RA, Taplin ME, Huang FW Prostate cancer‐specific mortality across Gleason scores in black vs nonblack men. JAMA 2018; 320: 2479– 81
  3. Sundi D, Kryvenko ON, Carter HB, Ross AE, Epstein JI, Schaeffer EM Pathological examination of radical prostatectomy specimens in men with very low risk disease at biopsy reveals distinct zonal distribution of cancer in black American men. J Urol 2014; 191: 60– 7
  4. Mahal BA, Alshalalfa M, Spratt DE Prostate cancer genomic‐risk differences between African‐American and white men across Gleason scores. Eur Urol 2019; 75: 1038– 40
  5. Sundi D, Ross AE, Humphreys EB et al. African American men with very low‐risk prostate cancer exhibit adverse oncologic outcomes after radical prostatectomy: should active surveillance still be an option for them? J Clin Oncol 2013; 31: 2991– 7
  6. Butler S, Muralidhar V, Chavez J et al. Active surveillance for low‐risk prostate cancer in black patients. N Engl J Med 2019; 380: 2070– 2

 

 

Video: Use of mpMRI and fusion‐guided biopsies to properly select and follow African‐American men on active surveillance

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Use of multiparametric magnetic resonance imaging and fusion‐guided biopsies to properly select and follow African‐American men on active surveillance

Read the full article

Abstract

Objectives

To determine the rate of Gleason Grade Group (GGG) upgrading in African‐American (AA) men with a prior diagnosis of low‐grade prostate cancer (GGG 1 or GGG 2) on 12‐core systematic biopsy (SB) after multiparametric magnetic resonance imaging (mpMRI) and fusion biopsy (FB); and whether AA men who continued active surveillance (AS) after mpMRI and FB fared differently than a predominantly Caucasian (non‐AA) population.

Patients and methods

A database of men who had undergone mpMRI and FB was queried to determine rates of upgrading by FB amongst men deemed to be AS candidates based on SB prior to referral. After FB, Kaplan–Meier curves were generated for AA men and non‐AA men who then elected AS. The time to GGG upgrading and time continuing AS were compared using the log‐rank test.

Results

AA men referred with GGG 1 disease on previous SB were upgraded to GGG ≥3 by FB more often than non‐AA men, 22.2% vs 12.7% (P = 0.01). A total of 32 AA men and 258 non‐AA men then continued AS, with a median (interquartile range) follow‐up of 39.19 (24.24–56.41) months. The median time to progression was 59.7 and 60.5 months, respectively (P = 0.26). The median time continuing AS was 61.9 months and not reached, respectively (P = 0.80).

Conclusions

AA men were more likely to be upgraded from GGG 1 on SB to GGG ≥3 on initial FB; however, AA and non‐AA men on AS subsequently progressed at similar rates following mpMRI and FB. A greater tendency for SB to underestimate tumour grade in AA men may explain prior studies that have shown AA men to be at higher risk of progression during AS.

View more videos

 

BJUI Compass and open access

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There is no doubt that the publishing landscape is rapidly changing around us. The BJUI is a world leading surgical journal, serving 10 international organisations, with 90 years of history (1929–2019). So why are we launching, BJUI Compass an online, open access (OA) journal, now?

In September 2018, cOAlition S, a predominantly European consortium of research funders, launched Plan S. In its current form, this plan requires that from 2021, scientific publications from research funded by public grants through funders who have signed up to cOAlition S must be published in full OA journals or platforms. This is a model whereby publication of science is paid for by authors, or their funders, rather than by readers to whom access is free [1]. The Wellcome Trust, one of the largest funders of research in the UK, is a major supporter of Plan S and has its own OA policy for 2021 [2].

However, the practical implementation of Plan S continues to be a subject of debate. In other parts of the world, there is increasing interest in OA but the approach to implementation is likely to vary considerably. Our own publisher, Wiley, in readiness for Plan S, announced an agreement with Projekt DEAL, a representative of nearly 700 academic institutions in Germany [3]. Most academic institutions in Germany under this project can publish articles in OA or hybrid journals published by Wiley, including BJUI, a hybrid journal. These initiatives in OA are another factor in the increasing debate about scientific impact, bibliometrics beyond the impact factor, and translating research for public benefit rather than purely the career progression of academics [4].

Dr John W. Davis (@jdhdavis)

 

In keeping with our continued theme of the highest quality, clinically relevant papers, in this issue of the BJUI we present two MRI‐based prostate cancer papers, showing that while we could avoid biopsies in many men without missing significant disease [5], in African‐American men on active monitoring, the cancers can be upgraded more frequently and careful follow‐up is thus warranted [6].

by Prokar Dasgupta and John W. Davis

 

References

  1. cOAlition S. Plan S: Making full and immediate Open Access a reality. Available at: https://www.coalition-s.org/. Accessed October 2019
  2. Wellcome. Open access policy 2021. Available at: https://wellcome.ac.uk/funding/guidance/open-access-policy. Accessed October 2019
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