Ultrasound Fusion–guided Biopsy with Ultrasound-guided Biopsy for the Diagnosis of Prostate Cancer

Ultrasound Fusion–guided Biopsy with Ultrasound-guided Biopsy for the Diagnosis of Prostate Cancer

536 EUROPEAN UROLOGY 68 (2015) 535–540 in TB, it will be essential to obtain consensus regarding best practice through investigative trials with the...

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536

EUROPEAN UROLOGY 68 (2015) 535–540

in TB, it will be essential to obtain consensus regarding best practice through investigative trials with the highest level of evidence. A critical key to developing solutions for the current PCa challenges might be the combination or alignment of clinical practice, technology, research, education, and scholarship through global collaboration and harmonization of competencies among urologists, radiologists, pathologists, and industry. This approach would generate a cycle in which research, education, and clinical care under new technology become increasingly interdependent and make each other better for our patients.

[2] Simmons LA, Ahmed HU, Moore CM, et al. The PICTURE study – prostate imaging (multi-parametric MRI and Prostate HistoScanningTM) compared to transperineal ultrasound guided biopsy for significant prostate cancer risk evaluation. Contemp Clin Trials 2014;37:69–83. [3] PI-RADS v2. Prostate Imaging and Reporting and Data System: version 2. American College of Radiology Web site. http://www. acr.org//media/ACR/Documents/PDF/QualitySafety/Resources/ PIRADS/PIRADS%20V2.pdf. Accessed April 6, 2015.

Massimo Lazzeri*, Giovanni Lughezzani, Giorgio Guazzoni Department of Urology, Humanitas Clinical and Research Center, Humanitas University, Rozzano, Milan, Italy

Conflicts of interest: The authors have nothing to disclose.

References

*Corresponding author. Department of Urology, Humanitas Clinical and Research Center, Humanitas University, via Manzoni 56,

[1] Valerio M, Donaldson I, Emberton M, et al. Detection of clinically

20089 Rozzano, Milan, Italy.

significant prostate cancer using magnetic resonance imaging–

E-mail address: [email protected] (M. Lazzeri).

ultrasound fusion targeted biopsy: a systematic review. Eur Urol 2015;68:8–19.

Re: Comparison of MR/Ultrasound Fusion–guided Biopsy with Ultrasound-guided Biopsy for the Diagnosis of Prostate Cancer Siddiqui MM, Rais-Bahrami S, Turkbey B, et al JAMA 2015;313:390–7 Experts’ summary: Siddiqui and colleagues examined the performance of targeted magnetic resonance imaging (MRI)/ultrasound (US) biopsy, standard 12-core biopsy, and the combination of the two in detecting prostate cancer in a prospective cohort of 1003 men. Importantly, targeted and standard biopsies were performed sequentially by two urologists, with the urologist performing the standard biopsy blinded to MRI results. Prostate cancer was diagnosed in a nearly equivalent proportions of patients by targeted biopsy alone and standard biopsy—461 and 469 patients, respectively—but the risk category was discordant for 31% of patients. Specifically, targeted biopsy diagnosed 51 (30%) more high-risk cancers but 45 (17%) fewer low-risk cancers compared to standard biopsy. When the two biopsy schemes were combined, an additional 103 (22%) cancers were detected, but 86 of these were of low risk. With the combination biopsy scheme, 200 men would need to undergo biopsy to diagnose one additional high-risk tumor compared to targeted biopsy alone, with concomitant diagnosis of 17 additional low-risk cancers. Of the three approaches, targeted biopsy demonstrated the best discrimination for detection of intermediate- and high-risk disease at prostatectomy, and had the greatest net benefit in decision curve analysis. Experts’ comments: Overdiagnosis of prostate cancer is estimated to occur in 23–42% of screen-detected cancers [1] and has increasingly been recognized as a significant limitation of prostate-specific antigen screening [2]. To this end, the study by Siddiqui et al suggests that targeted biopsy represents one strategy to improve detection of clinically significant prostate cancer

http://dx.doi.org/10.1016/j.eururo.2015.05.025

while reducing the detection of low-risk disease. For instance, screening of patients using multiparametric MRI may avoid morbidity associated with biopsy if no lesions are seen [3], and restriction of biopsy to a targeted approach would reduce overdiagnosis of low-risk disease [4]. The present study also has implications for active surveillance protocols because improved detection of intermediate- and high-risk prostate cancer may facilitate better selection of patients for initial biopsy [5]. The issue of whether targeted biopsy should be combined with systematic biopsy remains unresolved, as does the setting (initial evaluation vs follow-up of a previously negative biopsy). A limitation of the study reported by Siddiqui et al is the large number of men who had prior biopsies in which the peripheral zone was sampled. Thus, it would make sense that MRI-directed biopsy might detect a lesion previously not sampled by the ‘‘standard’’ approach. While combination biopsy had superior sensitivity, discrimination for intermediate- and highrisk disease was actually worse, probably because of lower specificity. It is also unlikely that targeted biopsy alone will replace systematic biopsy in the immediate future given the heterogeneity in MRI performance [4], a reluctance to miss even a few cases of significant cancer, and the higher cost. In the future, targeted biopsy may, together with emerging molecular frameworks such as genomic classifiers, optimize diagnosis and risk stratification. Further studies will provide the necessary validation and define the optimal integration of image-guided biopsy into current clinical paradigms. Conflicts of interest: The authors have nothing to disclose.

References [1] Draisma G, Etzioni R, Tsodikov A, et al. Lead time and overdiagnosis in prostate-specific antigen screening: importance of methods and context. J Natl Cancer Inst 2009;101:374–83.

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[2] Moyer VA. Screening for prostate cancer: U.S. Preventive Services

[5] Schoots IG, Petrides N, Giganti F, et al. Magnetic resonance imaging

Task Force recommendation statement. Ann Intern Med 2012;157:

in active surveillance of prostate cancer: a systematic review. Eur

120–34.

Urol 2015;67:627–36.

[3] Hamoen EHJ, de Rooij M, Witjes JA, Barentsz JO, Rovers MM. Use of the Prostate Imaging Reporting and Data System (PI-RADS) for

Boris Gershman, R. Jeffrey Karnes*

prostate cancer detection with multiparametric magnetic reso-

Department of Urology, Mayo Clinic, Rochester, MN, USA

nance imaging: a diagnostic meta-analysis. Eur Urol 2015;67: 1112–21.

*Corresponding author. Department of Urology, Mayo Clinic, 200 First

[4] Fu¨tterer JJ, Briganti A, De Visschere P, et al. Can clinically significant

Street SW, Rochester, MN 55905, USA.

prostate cancer be detected with multiparametric magnetic reso-

E-mail address: [email protected] (R.J. Karnes).

nance imaging? A systematic review of the literature. Eur Urol. In press. http://dx.doi.org/10.1016/j.eururo.2015.01.013

Re: Nadir Testosterone Within First Year of AndrogenDeprivation Therapy (ADT) Predicts for Time to Castration-Resistant Progression: A Secondary Analysis of the PR-7 Trial of Intermittent Versus Continuous ADT Klotz L, O’Callaghan C, Ding K, et al J Clin Oncol 2015;33:1151–6 Experts’ summary: In a post hoc analysis of the landmark phase III randomized PR-7 clinical trial, Klotz et al assessed the impact of testosterone levels in the first year of androgen deprivation therapy (ADT) on clinical outcome. The PR-7 study was designed to prospectively compare outcomes of continuous versus intermittent ADT in men with nonmetastatic biochemically recurrent prostate cancer (PCa) after surgery and/or radiation therapy. In this study, 696 patients were assigned to continuous androgen deprivation (CAD) with evaluation of serum testosterone and prostate-specific antigen every 2 mo and a median follow-up of 8 yr. In this arm, the current study demonstrated that a nadir of the testosterone value <0.7 nmol/l (20 ng/dl) in the first year of CAD was associated with longer time to development of castration-resistant PCa (CRPC) and better cancer specific survival compared with higher serum testosterone levels. Spikes of serum testosterone >1.7 nmol/l (50 ng/dl) also predicted time to CRPC and PCa mortality; however, testosterone levels at start of therapy did not. Experts’ comments: Men with biochemical recurrence (BCR) after radiation therapy or radical prostatectomy represent a heterogeneous population with highly variable outcomes [1]. Although ADT timing and type in these patients are still controversial, the objective is to provide deep castration to delay PCa progression and CRPC. In a significant subset of patients, serum testosterone response to luteinizing hormone–releasing hormone analogs does not reach the expected castrate levels, which have been set arbitrarily at an upper limit that ranges between 0.7 and 1.7 nmol/l. Despite initial response and observance, men will also experience spikes of testosterone. The clinical impact of these incomplete and variable responses remains controversial and poorly studied, specifically, in nonmetastatic PCa patients. Klotz et al, based on data from a prior randomized clinical trial, highlight that subcastrate nadir and spikes of testosterone during the first year of ADT in men with

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hormone-sensitive nonmetastatic PCa are associated with shorter time to CRPC and worse cancer-specific survival. This study has several implications that are increasingly based on cumulative evidence. Testosterone-level monitoring seems useful to help identify patients who may benefit from additional early therapies. Indeed, few prognosticators have been identified to help physicians with patient counseling and clinical decision making. Recently, a retrospective study in a large cohort of patients treated with external beam radiotherapy demonstrated that, except for Gleason score, established clinicopathologic features were not independent predictors for the development of CRPC [2]. It is likely that PCa progression and castration resistance relate to adverse biological and molecular features rather than baseline clinicopathologic characteristics alone. Testosterone levels were not associated with established clinicopathologic features of tumor aggressiveness in the current study. Consequently, response to ADT may reflect informative tumor and patient biological characteristics. In the era of personalized and tailored medicine, integration of such markers in predictive models is needed to identify patients who are more likely to experience short-term development of CRPC and thus may enter clinical trials that assess the role of ADT combination or intensification. The critical issue of the therapeutic decision when facing subcastrate patients still remains. No evidence shows that efforts to achieve early and continuous testosterone castrate levels would affect the outcome. The early introduction of ADT in nonmetastatic patients has not yet proven beneficial in terms of survival. The PR-7 study, according its primary end point, demonstrated that intermittent androgen deprivation, which leads to reincrease of testosterone in most patients, is not inferior to CAD [3]. Although it makes sense to discuss ADT manipulation, such as whether to switch to another type of ADT or add a new antiandrogen treatment to reach ‘‘supercastrate’’ levels in selected patients, results from ongoing clinical trials that address the benefit of these treatment modalities are still needed before any recommendation can be formalized. We have to mention some limitations, as outlined in the accompanying editorial [4]. First, the analyses did not assess overall survival. Competing risks and potential metabolic complications due to deeper castration levels may have limited the marginal benefit of cancer-specific survival,