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Editorial: Temporary Erectile Dysfunction Following Prostate Biopsy

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TRUS-guided prostate needle biopsy (PB) is considered to be the ‘gold standard’ for the diagnosis of prostate cancer. While serious side-effects (e.g. infection, sepsis and urinary retention) can occur after PB, they are relatively rare. Minor side-effects, including haematuria, haematospermia, rectal discomfort and bleeding, are more common but are usually self-limiting. As such, men undergoing biopsy are usually counselled about these risks, which generally occur at an acceptably low frequency and are outweighed by the potential benefits of PB.

Penile erection is a complex physiological process that occurs through a coordinated cascade of neurological, vascular, humoral and psychological events. Therefore, there are a multitude of factors that could ultimately influence or disrupt normal erectile function after PB, including type of anaesthetic, age, psychological stress and damage to the neurovascular bundles. Erectile dysfunction (ED) and worsening LUTS have been reported to occur after PB, but the true incidence and possible pathophysiology remain subject to debate. For example, in their manuscript entitled, ‘A prospective study of erectile function after transrectal ultrasound and prostate biopsy’, Murray et al. [1] conducted a prospective study assessing erectile function, measured by the International Index of Erectile Function (IIEF-5), and LUTS, measured by the IPSS, after PB. The results suggest that there is a significant decrease in erectile function that persists up to 3 months after PB. By contrast, worsening LUTS were not documented at this time after PB.

The present prospectively conducted trial [1] supports the findings of some other retrospective studies [2], but contradicts others [3–5]. For example, Helfand et al. [6] previously documented that a diagnosis of prostate cancer can influence a man’s erectile function after PB. Similarly, Murray et al. [1] found that patients without a diagnosis of prostate cancer reported lower IIEF scores up to 3 weeks, whereas those diagnosed with the disease had significantly lower IIEF scores up to 3 months after PB. Taken together, these results support other studies [2,6] showing that the psychological stress associated with a cancer diagnosis might contribute to ED.

Other recent studies have supported the notion that PB does not influence the frequency of ED [3–5]. These data have been mainly obtained from studies of men undergoing repeated PB as part of an active surveillance protocol. Some of these discrepancies might be related to the timing of evaluation after PB (e.g. 3 vs 12 months). Nonetheless, other studies found that age may be a better predictor of changes in erectile function. For example, data obtained from Braun et al. [3] support that men who undergo multiple biopsies (a median of five PB) fail to report substantially decreased erectile function over time. Similarly, Hilton et al. [4] found that erectile function scores were strongly associated with age and sexual activity, and not number of PBs. In support of this age relationship, the present study found that men aged <60 years had lower IIEF scores only at 1 week, compared with those patients aged >60 years who continued to report sexual side-effects up to 3 months after PB [1].

When the results of Murray et al. [1] are considered in light of previous studies on this topic, it appears that patients should be counselled on the possibility of relatively short-term (‘acute’) changes in erectile function. However, it should also be emphasised that long-term ED might not be related to the PB procedure itself, but rather to other factors, including advanced age, psychological stress and/or prostate cancer diagnosis.

 

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Brian Helfand

North Shore University Health System, Division of Urology, John and Carol Walter Center for Urological Health, Evanston, IL, USA.

University of Chicago, Chicago, IL, USA.

 

References

1 Murray KS, Bailey J, Zuk K, Lopez-Corona E, Thrasher JB. A prospective study of erectile function after transrectal ultrasound and prostate biopsy. BJU Int 2015; 116: 190–5

2 Zisman A, Leibovici D, Kleinmann J, Cooper A, Siegel Y, Lindner A. The impact of prostate biopsy on patient well-being: a prospective study of voiding impairment. J Urol 2001; 166: 2242–6

3 Braun K, Ahallal Y, Sjoberg DD et al. Effect of repeated prostate biopsies on erectile function in men on active surveillance for prostate cancer. J Urol 2014; 191: 744–9

4 Hilton JF, Blaschko SD, Whitson JM, Cowan JE, Carroll PR. The impact of serial prostate biopsies on sexual function in men on active surveillance for prostate cancer. J Urol 2012; 188: 1252–8

5 Chrisofos M, Papatsoris AG, Dellis A, Varkarakis IM, Skolarikos A, Deliveliotis C. Can prostate biopsies affect erectile function? Andrologia 2006; 38: 79–83

6 Helfand BT, Glaser AP, Rimar K et al. Prostate cancer diagnosis is associated with an increased risk of erectile dysfunction after prostate biopsy. BJU Int 2013; 111: 38–43

Video: A prospective study of erectile function after transrectal ultrasonography-guided prostate biopsy

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A prospective study of erectile function after transrectal ultrasonography-guided prostate biopsy

 

Murray KS1, Bailey J2, Zuk K3, Lopez-Corona E4, Thrasher JB1,4.

 

Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.

Kansas City University of Medicine and Biosciences, Kansas City, KS, USA.

University of Kansas School of Medicine, Kansas City, KS, USA.

Kansas City Veterans Administration Medical Center, Kansas City, KS, USA.

 

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OBJECTIVE

To prospectively evaluate the effect of transrectal ultrasonography (TRUS)-guided prostate biopsy on erectile and voiding function at multiple time-points after biopsy.

PATIENTS AND METHODS

All men who underwent TRUS-guided prostate biopsy completed a five-item version of the International Index of Erectile Function (IIEF-5) and the International Prostate Symptom Score (IPSS) before and at 1, 4 and 12 weeks after TRUS-guided biopsy. Statistical analyses used were a general descriptive analysis, continuous variables using a t-test and categorical data using chi-square analysis. A paired t-test was used to compare each patient’s baseline score to their own follow-up survey scores.

RESULTS

In all, 220 patients were enrolled with a mean age of 64.1 years and PSA level of 6.7 ng/dL. At initial presentation, 38.6% reported no erectile dysfunction (ED), 22.3% mild ED, 15.5% mild-to-moderate ED, 10% moderate ED, and 13.6% severe ED. On paired t-test there was a statistically significant reduction in IIEF-5 score at 1 week after biopsy compared with before biopsy (18.2 vs 15.5; P < 0.001). This remained significantly reduced at 4 (18.4 vs 17.3; P = 0.008) and 12 weeks (18.4 vs 16.9, P = 0.004) after biopsy.

CONCLUSIONS

The effects of TRUS-guided prostate biopsy on erectile function have probably been underestimated. It is important to be aware of these transient effects so patients can be appropriately counselled. The exact cause of this effect is yet to be determined.

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Article of the Month: The PROMEtheuS Project: Bringing PHI to prostate Cancer

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Every week the Editor-in-Chief selects the 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 accompanying editorial written by a prominent member of the urological community. This blog is 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.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Alberto Abrate, discussing his paper. 

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

Clinical performance of Prostate Health Index (PHI) for prediction of prostate cancer in obese men: data from a multicenter European prospective study, PROMEtheuS project

Alberto Abrate, Massimo Lazzeri, Giovanni Lughezzani, Nicolòmaria Buffi, Vittorio Bini*,Alexander Haese†, Alexandre de la Taille‡, Thomas McNicholas§, Joan Palou Redorta¶,Giulio M. Gadda, Giuliana Lista, Ella Kinzikeeva, Nicola Fossati, Alessandro Larcher,Paolo Dell’Oglio, Francesco Mistretta, Massimo Freschi** and Giorgio Guazzoni

Division of Oncology, Unit of Urology, URI, **Department of Pathology, IRCCS Ospedale San Raffaele, UniversitàVita-Salute San Raffaele, Milan, *Department of Internal Medicine, University of Perugia, Perugia, Italy,†Martini-ClinicProstate Cancer Center, University Clinic Hamburg-Eppendorf, Hamburg, Germany,‡Department of Urology, APHPMondor Hospital, Créteil, France,§South Bedfordshire and Hertfordshire Urological Cancer Centre, Lister Hospital,Stevenage, UK, and¶Urologic Oncology Section of the Department of Urology and Radiology Department, FundaciòPuigvert, Barcelona, Spain

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OBJECTIVES

To test serum prostate-specific antigen (PSA) isoform [-2]proPSA (p2PSA), p2PSA/free PSA (%p2PSA) and Prostate Health Index (PHI) accuracy in predicting prostate cancer in obese men and to test whether PHI is more accurate than PSA in predicting prostate cancer in obese patients.

PATIENTS AND METHODS

The analysis consisted of a nested case-control study from the pro-PSA Multicentric European Study (PROMEtheuS) project. The study is registered at https://www.controlled-trials.com/ISRCTN04707454. The primary outcome was to test sensitivity, specificity and accuracy (clinical validity) of serum p2PSA, %p2PSA and PHI, in determining prostate cancer at prostate biopsy in obese men [body mass index (BMI) ≥30 kg/m2], compared with total PSA (tPSA), free PSA (fPSA) and fPSA/tPSA ratio (%fPSA). The number of avoidable prostate biopsies (clinical utility) was also assessed. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision-curve analysis.

RESULTS

Of the 965 patients, 383 (39.7%) were normal weight (BMI <25 kg/m2), 440 (45.6%) were overweight (BMI 25–29.9 kg/m2) and 142 (14.7%) were obese (BMI ≥30 kg/m2). Among obese patients, prostate cancer was found in 65 patients (45.8%), with a higher percentage of Gleason score ≥7 diseases (67.7%). PSA, p2PSA, %p2PSA and PHI were significantly higher, and %fPSA significantly lower in patients with prostate cancer (P < 0.001). In multivariable logistic regression models, PHI significantly increased accuracy of the base multivariable model by 8.8% (P = 0.007). At a PHI threshold of 35.7, 46 (32.4%) biopsies could have been avoided.

CONCLUSION

In obese patients, PHI is significantly more accurate than current tests in predicting prostate cancer.

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Editorial: Time to replace PSA with the PHI?

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Yet more evidence that the PHI consistently outperforms PSA across diverse populations

The Prostate Health Index (PHI) has regulatory approval in >50 countries worldwide and is now being incorporated into prostate cancer guidelines; for example, the 2014 National Comprehensive Cancer Network Guidelines for early prostate cancer detection discuss the PHI as a means to improve specificity, using a threshold score of 35 [1]. The PHI is also discussed in the Melbourne Consensus Statement [2], and it has been incorporated into the multivariable Rotterdam risk calculator smartphone app for use in point-of-care decisions [3].

As the use of this test continues to expand, more data on its performance in specific at-risk populations are of great interest. The investigators from the PROMEtheus multicentre European trial have previously validated the use of the PHI in men with a positive family history of prostate cancer [4]. The new study by Abrate et al. in this issue of BJUI instead addresses another high-risk population – obese men – who have previously been shown to have a greater risk of aggressive prostate cancer [5].

Among the 965 participants in the PROMEtheus study, 14.7% were considered obese based on a body mass index ≥30 kg/m2. In this group, 45.8% were diagnosed with prostate cancer from a ≥12-core biopsy, and 67.7% had a Gleason score ≥7. Overall, the PHI significantly outperformed PSA for prostate cancer detection in men with a body mass index ≥30 kg/m2 (area under the curve 0.839 vs 0.694; P < 0.001). At 90% sensitivity, the threshold for PHI in obese men was 35.7, with a specificity of 52.3%. The PHI also had the best performance for the detection of Gleason ≥7 disease, with an area under the curve of 0.89.

These findings add to the highly consistent body of evidence supporting the use of the PHI in early prostate cancer detection and risk stratification. In fact, all published studies to date have shown that the PHI outperforms PSA for detection of overall and high-grade prostate cancer detection on biopsy [6]. Numerous studies have also shown a role for the PHI in patient selection and monitoring during active surveillance [7, 8]. Expanded use of this test is warranted to reduce unnecessary biopsies and better identify cancers with life-threatening potential.

Read the full article
Stacy Loeb
Department of Urology and Population Health, New York University, New York, NY, USA

 

References

1 National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Prostate Cancer Early Detection Version 2014. https://www.nccn.org/professionals/physician_gls/pdf/prostate_detection.pdf.Accessed May 26, 2014

2 Murphy DG, Ahlering T, Catalona WJ et al. The melbourne consensus statement on the early detection of prostate cancer. BJU Int 2014; 113:186–8

3 Roobol M, Salman J, Azevedo N. Abstract 857: The Rotterdam Prostate Cancer Risk Calculator: Improved Prediction with More Relevant Pre-Biopsy Information, Now in the Palm of Your Hand. Stockholm: European Association of Urology, 2014

4 Lazzeri M, Haese A, Abrate A et al. Clinical performance of serum prostate-specific antigen isoform [-2]pr oPSA (p2PS A) and its derivatives, %p2PSA and the prostate health index (PHI), in men with a family history of prostate cancer: results from a multicentre European study, the PROMEtheuS project. BJU Int 2013; 112:313–21

5 Freedland SJ, Banez LL, Sun LL, Fitzsimons NJ, Moul JW. Obese men have higher-grade and larger tumors: an analysis of the duke prostate center database. Prostate Cancer Prostatic Dis 2009; 12: 259–63

6 Filella X, Gimenez N. Evaluation of [-2] proPSA and Prostate Health Index (phi) for the detection of prostate cancer: a systematic review and meta-analysis. Clin Chem Lab Med 2013; 51: 729–39

7 Tosoian JJ, Loeb S, Feng Z et al. Association of [-2]proPSA with Biopsy Reclassification During Active Surveillance for Prostate Cancer. J Urol2012; 188: 1131–6

8 Hirama H, Sugimoto M, Ito K, Shiraishi T, Kakehi Y. The impact of baseline [-2]proPSA-related indices on the prediction of pathological reclassification at 1 year during active surveillance for low-risk prostate cancer: the Japanese multicenter study cohort. J Cancer Res Clin Oncol2014; 140: 257–63

 

Video: Clinical performance of PHI for prediction of prostate cancer: data from the PROMEtheuS project

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Clinical performance of Prostate Health Index (PHI) for prediction of prostate cancer in obese men: data from a multicenter European prospective study, PROMEtheuS project

Alberto Abrate, Massimo Lazzeri, Giovanni Lughezzani, Nicolòmaria Buffi, Vittorio Bini*,Alexander Haese†, Alexandre de la Taille‡, Thomas McNicholas§, Joan Palou Redorta¶,Giulio M. Gadda, Giuliana Lista, Ella Kinzikeeva, Nicola Fossati, Alessandro Larcher,Paolo Dell’Oglio, Francesco Mistretta, Massimo Freschi** and Giorgio Guazzoni

Division of Oncology, Unit of Urology, URI, **Department of Pathology, IRCCS Ospedale San Raffaele, UniversitàVita-Salute San Raffaele, Milan, *Department of Internal Medicine, University of Perugia, Perugia, Italy,†Martini-ClinicProstate Cancer Center, University Clinic Hamburg-Eppendorf, Hamburg, Germany,‡Department of Urology, APHPMondor Hospital, Créteil, France,§South Bedfordshire and Hertfordshire Urological Cancer Centre, Lister Hospital,Stevenage, UK, and¶Urologic Oncology Section of the Department of Urology and Radiology Department, FundaciòPuigvert, Barcelona, Spain

Read the full article
OBJECTIVES

To test serum prostate-specific antigen (PSA) isoform [-2]proPSA (p2PSA), p2PSA/free PSA (%p2PSA) and Prostate Health Index (PHI) accuracy in predicting prostate cancer in obese men and to test whether PHI is more accurate than PSA in predicting prostate cancer in obese patients.

PATIENTS AND METHODS

The analysis consisted of a nested case-control study from the pro-PSA Multicentric European Study (PROMEtheuS) project. The study is registered at https://www.controlled-trials.com/ISRCTN04707454. The primary outcome was to test sensitivity, specificity and accuracy (clinical validity) of serum p2PSA, %p2PSA and PHI, in determining prostate cancer at prostate biopsy in obese men [body mass index (BMI) ≥30 kg/m2], compared with total PSA (tPSA), free PSA (fPSA) and fPSA/tPSA ratio (%fPSA). The number of avoidable prostate biopsies (clinical utility) was also assessed. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision-curve analysis.

RESULTS

Of the 965 patients, 383 (39.7%) were normal weight (BMI <25 kg/m2), 440 (45.6%) were overweight (BMI 25–29.9 kg/m2) and 142 (14.7%) were obese (BMI ≥30 kg/m2). Among obese patients, prostate cancer was found in 65 patients (45.8%), with a higher percentage of Gleason score ≥7 diseases (67.7%). PSA, p2PSA, %p2PSA and PHI were significantly higher, and %fPSA significantly lower in patients with prostate cancer (P < 0.001). In multivariable logistic regression models, PHI significantly increased accuracy of the base multivariable model by 8.8% (P = 0.007). At a PHI threshold of 35.7, 46 (32.4%) biopsies could have been avoided.

CONCLUSION

In obese patients, PHI is significantly more accurate than current tests in predicting prostate cancer.

Read more articles of the week

Article of the Month: Indications for Intervention During Active Surveillance of Prostate Cancer

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Every week the Editor-in-Chief selects the 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 accompanying editorial written by a prominent member of the urological community. This blog is 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.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Max Kates discussing his paper. 

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

Indications for Intervention During Active Surveillance of Prostate Cancer: A Comparison of the Johns Hopkins and PRIAS Protocols

Max Kates, Jeffrey J. Tosoian, Bruce J. Trock, Zhaoyong Feng, H. Ballentine Carter and Alan W. Partin
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA
Read the full article
OBJECTIVE

To analyse how patients enrolled in our biopsy based surveillance programme would fare under the Prostate Cancer Research International Active Surveillance (PRIAS) protocol, which uses PSA kinetics.

PATIENTS AND METHODS

Since 1995, 1125 men with very-low-risk prostate cancer have enrolled in the AS programme at the Johns Hopkins Hospital (JHH), which is based on monitoring with annual biopsy. The PRIAS protocol uses a combination of periodic biopsies (in years 1, 4, and 7) and prostate-specific antigen doubling time (PSADT) to trigger intervention. Patients enrolled in the JHH AS programme were retrospectively reviewed to evaluate how the use of the PRIAS protocol would alter the timing and use of curative intervention.

RESULTS

Over a median of 2.1 years of follow up, 38% of men in the JHH AS programme had biopsy reclassification. Of those, 62% were detected at biopsy intervals corresponding to the PRIAS criteria, while 16% were detected between scheduled PRIAS biopsies, resulting in a median delay in detection of 1.9 years. Of the 202 men with >5 years of follow-up, 11% in the JHH programme were found to have biopsy reclassification after it would have been identified in the PRIAS protocol, resulting in a median delay of 4.7 years to reclassification. In all, 12% of patients who would have undergone immediate intervention under PRIAS due to abnormal PSA kinetics would never have undergone reclassification on the JHH protocol and thus would not have undergone definitive intervention.

CONCLUSIONS

There are clear differences between PSA kinetics-based AS programmes and biopsy based programmes. Further studies should address whether and how the differences in timing of intervention impact subsequent disease progression and prostate cancer mortality.

Read more articles of the week

 

Editorial: How active should active surveillance be?

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 Many investigators, including those from Johns Hopkins University (JHU) and the Prostate cancer Research International: Active Surveillance project (PRIAS), have provided meaningful data to strongly support the increasing use of active surveillance (AS) across the world. There are a multitude of strategies to minimise excessive rates of prostate cancer over detection and overtreatment. After the diagnosis of prostate cancer, the single best is AS for appropriately selected men.

 For decades, the concept of not treating a prostate cancer in otherwise healthy men, even if low-grade and low-volume was typically considered nihilistic and heretical, particularly in the USA. Thankfully, data have largely made this line of thinking anachronistic. The era of sensibly applied AS is upon us, and single-institution series with intermediate-term follow-up are excellent, with exceedingly low rates of metastasis or cancer-related death. However, we await longer-term (>10 years) outcomes from the contemporary PSA screening era.

 The ‘success’ of AS is largely dependent on the entry criteria, follow-up strategies, and indications for curative intervention. Highly restrictive inclusion criteria, rigorous biopsy based follow-up and strict definitions of reclassification triggering treatment have produced superb outcomes. Critics appropriately argue these criteria exclude a significant proportion of men with a low rate of requiring treatment or having metastases, if allowed on AS. Conversely, other programmes with looser entry criteria, more lax follow-up, and relaxed indications for intervention will be more inclusive and have lower rates of immediate or delayed intervention but must be counterbalanced against the expected higher rate of metastases or death.

 The current study [1] evaluates two different AS follow-up strategies from JHU and PRIAS. In general, JHU uses annual biopsies with progression defined as a new PSA density >0.15 ng/mL/mL or increasing tumour volume or grade beyond a certain threshold, while PRIAS recommends less frequent biopsies (years 1, 4, and 7) while relying on serological (PSA doubling time, PSADT) alongside histological indicators for defining progression and recommending treatment.

 Not surprisingly, different strategies lead to varying expected outcomes. Among the JHU patients, 38% were reclassified at a median of 2.1 years. Nearly two-thirds of the reclassified would have been identified at the PRIAS year 1 or triennial biopsies with 16% identified between PRIAS biopsies at a median delay of 1.9 years. The unanswerable but incredibly important question is whether this delay is essentially a non-issue, perhaps a favourable attribute (more AS time without compromising cure rates), or clinically disastrous (patients no longer curable).

 PRIAS relies heavily on PSA kinetics, which can be a double-edged sword. Among men in the JHU programme with >5 years follow-up, 11% would have delayed reclassification compared with PRIAS at a median time of 4.7 years. Additionally, 12% would have undergone intervention due to PRIAS-defined PSADT but not progressed based on the JHU protocol. It is convenient and perhaps intuitive that PSA kinetics should predict progression and meaningful clinical events for men on AS; however, the data from multiple studies have simply not supported this concept [2, 3].

 The JHU programme has restrictive entry rules compared with most other programmes, a rigorous biopsy based follow-up protocol, and strict criteria to treat, which is exactly why no metastasis or death have been reported among 769 men, some with up to 15 years follow-up[4]. Guidelines are needed but should not be overly prescriptive or rigid. For example, a surveillance biopsy showing a single core of Gleason 6 encompassing 60% of the total core or three cores of Gleason 6 with total cancer length of 3 mm would lead to a recommendation of treatment according to published JHU criteria. Many of us would not be phased with these biopsy reports and comfortably recommend ongoing AS.

 Data from AS series are very encouraging but it is highly likely we can do even better. For example, 10-year cancer-specific survival is 97% in the Sunnybrook AS experience and all five cancer-related deaths occurred in patients that would not meet most contemporary AS entry criteria [5, 6]. I am hopeful and confident that emerging data incorporating MRI imaging, serum biomarkers (e.g. prostate health index), or tissue-based biomarkers (e.g. Prolaris, Oncotype Dx) will provide us with a more comprehensive understanding of these men’s cancer such that tailored, evidence-based recommendations can be even more accurate.

 There is much yet to be learned about AS and this study [1] adds to our knowledge. Surveillance for prostate cancer is definitely active, but it is also dynamic and evolving.

Read the full article
Scott Eggener
Associate Professor of Surgery, University of Chicago, Chicago, IL, USA

 

References

 

1 Kates M, Tosoian JJ, Trock BJ, Feng Z, Carter HB, Partin AW. Indications for intervention during active surveillance of prostate cancer:
a comparison of the Johns Hopkins and Prostate Cancer Research International Active Surveillance (PRIAS) protocols. BJU Int 2015; 115: 216–22

 

2 Whitson JM, Porten SP, Hilton JF et al. The relationship between prostate specific antigen change and biopsy progression in patients on active surveillance for prostate cancer. J Urol 2011; 185: 1656–60

 

3 Fall K, Garmo H, Andrén O et al. Prostate-specific antigen levels as a predictor of lethal prostate cancer. JNatlCancerInst2007; 99: 526–32

 

4 Tosoian JJ, Trock BJ, Landis P et al. Active surveillance program for prostate cancer: an update of the Johns Hopkins experience. J Clin Oncol 2011; 29: 2185–90

 

5 Klotz L, Zhang L, Lam A, Nam R, Mamedov A, Loblaw A. Clinical results of long-term follow-up of a large, active surveillance cohort with localized prostate cancer. J Clin Oncol 2010; 28: 126–31

 

6 Krakowsky Y, Loblaw A, Klotz L. Prostate cancer death of men treated with initial active surveillance: clinical and biochemical characteristics. J Urol 2010; 184: 131–5

 

Video: Indications for Intervention During Active Surveillance of Prostate Cancer: A Comparison of the Johns Hopkins and PRIAS Protocols

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Indications for Intervention During Active Surveillance of Prostate Cancer: A Comparison of the Johns Hopkins and PRIAS Protocols

Max Kates, Jeffrey J. Tosoian, Bruce J. Trock, Zhaoyong Feng, H. Ballentine Carter and Alan W. Partin
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA
Read the full article
OBJECTIVE

To analyse how patients enrolled in our biopsy based surveillance programme would fare under the Prostate Cancer Research International Active Surveillance (PRIAS) protocol, which uses PSA kinetics.

PATIENTS AND METHODS

Since 1995, 1125 men with very-low-risk prostate cancer have enrolled in the AS programme at the Johns Hopkins Hospital (JHH), which is based on monitoring with annual biopsy. The PRIAS protocol uses a combination of periodic biopsies (in years 1, 4, and 7) and prostate-specific antigen doubling time (PSADT) to trigger intervention. Patients enrolled in the JHH AS programme were retrospectively reviewed to evaluate how the use of the PRIAS protocol would alter the timing and use of curative intervention.

RESULTS

Over a median of 2.1 years of follow up, 38% of men in the JHH AS programme had biopsy reclassification. Of those, 62% were detected at biopsy intervals corresponding to the PRIAS criteria, while 16% were detected between scheduled PRIAS biopsies, resulting in a median delay in detection of 1.9 years. Of the 202 men with >5 years of follow-up, 11% in the JHH programme were found to have biopsy reclassification after it would have been identified in the PRIAS protocol, resulting in a median delay of 4.7 years to reclassification. In all, 12% of patients who would have undergone immediate intervention under PRIAS due to abnormal PSA kinetics would never have undergone reclassification on the JHH protocol and thus would not have undergone definitive intervention.

CONCLUSIONS

There are clear differences between PSA kinetics-based AS programmes and biopsy based programmes. Further studies should address whether and how the differences in timing of intervention impact subsequent disease progression and prostate cancer mortality.

Read more articles of the week

Article of the week: Prostate biopsy: shaking up the old standard

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Every week the Editor-in-Chief selects the 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 accompanying editorial written by a prominent member of the urological community. This blog is 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.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video of Dr Symons discussing his paper.

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

Outcomes of transperineal template-guided prostate biopsy in 409 patients

James L. Symons*†, Andrew Huo*, Carlo L. Yuen‡§, Anne-Maree Haynes*, Jayne Matthews†, Robert L. Sutherland*, Phillip Brenner‡§ and Phillip D. Stricker†‡§

*Cancer Research Programme, Garvan Institute of Medical Research, †St Vincent’s Prostate Cancer Centre, ‡Department of Urology, St. Vincent’s Hospital, and §Department of Urology, St. Vincent’s Clinic, Darlinghurst, NSW, Australia

Read the full article
OBJECTIVE

• To present the template-guided transperineal prostate biopsy (TPB) outcomes for patients of two urologists from a single institution.

PATIENTS AND METHODS

• We conducted a prospective study of 409 consecutive men who underwent TPB between December 2006 and June 2008 in a tertiary referral centre using a standardized 14-region technique.

• The procedure was performed as day surgery under general anaesthesia with fluoroquinolone antibiotic cover.

• Follow-up took place within 2 weeks, during which time men were interviewed using a standardized template.

• Results were compared with those of the Australian national prostate biopsy audits performed by the Urological Society of Australia and New Zealand (USANZ).

RESULTS

• Indications for biopsy included elevated prostate-specific antigen (PSA) level (75%), with a median PSA level of 6.5 ng/mL, abnormal digital rectal examination (8%) and active surveillance (AS) re-staging (18%).

• The mean patient age was 63 years and two-thirds of patients were undergoing their first biopsy.

• A positive biopsy was found in 232 men, 74% of whom had a Gleason score of ≥7. The overall cancer detection rate was 56.7% (USANZ 2005 national audit = 56.5%). Stratified between those having their first TPB or a repeat procedure (after a previous negative biopsy), the detection rates were 64.4 and 35.6%, respectively. Significantly higher detection rates were found in prostates <50 mL in volume than in larger prostates (65.2 vs 38.3%, respectively, P < 0.001).

• Haematuria was the most common side effect (51.7%). Others included dysuria (16.4%), acute urinary retention (4.2%) and fever (3.2%). One patient (0.2%) had septicaemia requiring i.v. antibiotics.

• Repeat biopsy was not associated with increased complication rates.

CONCLUSIONS

• TPB is a safe and efficacious technique, with a cancer detection rate of 56.7% in the present series, and a low incidence of major side effects. Stratified by prostate volume, the detection rate of TPB was higher in smaller glands.

• Given the relatively low rate of serious complications, clinicians could consider increasing the number of TPB biopsy cores in larger prostates as a strategy to improve cancer detection within this group. Conversely, in patients on AS programmes, a staging TPB may be a superior approach for patients undergoing repeat biopsy so as to minimize their risk of serious infection.

Editorial: Contemplate the template: a new prostate biopsy approach

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Transperineal magnetic resonance imaging – ultrasound fusion targeted biopsies (MRI-US FTB) of the prostate: the future of prostate diagnostics

The prostate cancer diagnostic pathway has remained unchanged for 25 years. At best, laterally directed, peripheral zone (PZ) 12-core transrectal biopsies identify cancer in 44% of cases [1] but transrectal biopsies have an inherent sampling error with a risk of misdiagnosis or mischaracterisation of disease. Of those with negative biopsies who undergo transperineal (TP) biopsies, 30% have cancer, most in the anterior PZ. Active surveillance and the promise of less invasive treatment options are becoming popular because of concerns about ‘over treatment’ for low-risk disease.

Saturation transrectal biopsies have been advocated to improve diagnostic yield but do not address the issue of under sampling of the anterior PZ, particularly in the larger gland [2]. TP biopsies can be used to address the issue of under sampling but prostate template-mapping biopsies are labour intensive and require large numbers of biopsies, often between 60 to 90 cores; however, they have been an essential component of focal therapy trials and the evaluation of novel treatment methods [3].

Primary TP biopsy is the subject of the paper published in this edition of the BJUI titled ‘Outcomes of transperineal template-guided prostate biopsy in 409 patients’ [4]. The authors report a single centre experience of primary TP biopsies. The 14-region protocol described is simpler than prostate template-mapping requiring fewer cores (median of 15 and mean of 19 cores) with a comparable primary diagnostic detection rate of 60% and an encouraging side-effect profile. Unfortunately, the approach still has limitations and the authors admit that their limited biopsy protocol may still mischaracterise disease in the larger gland. In a recent paper from the same group, there was a disappointing correlation between their TP biopsy pathology, MRI abnormalities and radical prostatectomy specimens [5]. Uncertainty prevails, the problem is how best to sample the larger gland. The authors [4] and others, often conclude that more biopsies are necessary for larger glands and resort to mapping protocols and many more biopsies. The solution may not be more biopsies but rather better systematic targeting of the PZ. The impact of hyperplasia within the transition zone (TZ) has a profound effect on PZ anatomy. In the smaller prostate, up to 30 mL, there is little TZ and the PZ is much thicker posteriorly than anteriorly, this difference is even more apparent in glands of 30–50 mL. Above 50 mL TZ expansion causes marked attenuation of the PZ, which becomes much thinner, but the overall volume of the PZ does not change. Less than 4% of cancers originate in the TZ [6], consequently biopsies should be concentrated primarily on the PZ.

The future of prostate cancer diagnosis is likely to be a combination of pre-biopsy multiparametric MRI, followed by targeted biopsies of MRI-identified lesions combined with fewer but better systematic targeted biopsies of the PZ. MRI-ultrasound (MRI-US) fusion techniques have been developed in which axial T2 images of the prostate, diffusion-weighted images and/or dynamic contrast-enhanced MRI images are ‘fused’ with the live US images to allow precise targeting of both regions of interest and the PZ. Commercially available biopsy programs, developed from brachytherapy software systems programs allow individual biopsy sites to be recorded and if combined with inking of the specimen can provide precise pathological localisation of disease within the prostate [7].

There are many potential benefits to this approach. Patients who opt for active surveillance will have an archived record of their disease at a given time to facilitate precise replication of further interval biopsies and assess progression. Improved disease management for an individual should be the aim. The suitability or not for focal or targeted therapies, the planning or boosting of identifed lesions with radiotherapy and/or brachytherapy, and the planning of nerve-sparing surgery or wide excisions should be possible. Feedback to the radiologists of both benign and malignant pathology and grade of disease will improve reporting accuracy and provide imaging sciences with the histopathological characteristics of both MRI ‘visible’ and ‘invisible’ cancer to improve MRI interpretation.

MRI–US fusion targeted biopsies are a significant advance in prostate diagnostics and may resolve some uncertainty within the prostate cancer diagnostic pathway. Benefit vs cost is a recurring issue across health care and questions will continue to be asked about the use of increasingly expensive technology in such an indolent disease. The challenge for investigators will be how to prove the benefit of this approach over standard biopsy protocols and integrate this work in to clinical practice.

Richard Popert
Department of Urology, Guy’s Hospital, London, UK

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References
  1. Presti JC, O’Dowd GL, Miller MC et al. Extended peripheral zone biopsy schemes increase cancer detection rates and minimize variance in prostate specific antigen and age related cancer rates: results of a community multi-practice study. J Urol 2003; 169:125–129
  2. Stewart CS, Leibovich BC, Weaver AL, Lieber MM. Prostate cancer diagnosis using a saturation needle biopsy technique after previous negative sextant biopsies. J Urol 2001; 166: 86–92
  3. Onik G, Barzell W. Transperineal 3D mapping biopsy of the prostate: an essential tool in selecting patients for focal prostate cancer therapy. Urol Oncol 2008; 26: 506–510
  4. Symons JL, Huo A, Yuen CL et al. Outcomes of transperineal template-guided prostate biopsy in 409 patients. BJU Int 2013; 112: 585–593
  5. Huo AS, Hossack T, Symons JL et al. Accuracy of primary systematic template guided transperineal biopsy of the prostate for locating prostate cancer: a comparison with radical prostatectomy specimens. J Urol 2012; 187: 2044–2050
  6. Patel V, Merrick GS, Allen ZA et al. The incidence of transition zone prostate cancer diagnosed by transperineal template guided mapping biopsy: implications for treatment planning. Urology 2011; 77: 1148–1152
  7. Hadaschik BA, Kuru TH, Tulea C et al. A novel stereotactic prostate biopsy system integrating pre-interventional magnetic resonance imaging and live ultrasound fusion. J Urol 2011; 186: 2214–2220
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