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Article of the Month: SRP for recurrent Prostate Cancer – Verification of EAU guideline criteria

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Every Month the Editor-in-Chief selects an Article of the Month 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.

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

Salvage Radical Prostatectomy for recurrent Prostate Cancer: Verification of EAU guideline criteria

Philipp Mandel*†, Thomas Steuber*†, Sascha Ahyai†, Maximilian Kriegmair‡, Jonas Schiffmann*, Katharina Boehm*, Hans Heinzer*, Uwe Michl*, Thorsten Schlomm*†, Alexander Haese*, Hartwig Huland*, Markus Graefen* and Derya Tilki*†

 

*Martini-Clinic Prostate Cancer Center, †Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg , and ‡Department of Urology, University Hospital Mannheim, Mannheim, Germany

 

Note: Figure 3 should be swapped with Figure 4. The legends for both figures stay the same and the referencing in the text is correct.

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OBJECTIVE

To analyse oncological and functional outcomes of salvage radical prostatectomy (SRP) in patients with recurrent prostate cancer and to compare outcomes of patients within and outside the European Association of Urology (EAU) guideline criteria (organ-confined prostate cancer ≤T2b, Gleason score ≤7 and preoperative PSA level <10 ng/mL) for SRP.

PATIENTS AND METHODS

In all, 55 patients who underwent SRP from January 2007 to December 2012 were retrospectively analysed. Kaplan–Meier curves assessed time to biochemical recurrence (BCR), metastasis-free survival (MFS) and cancer-specific survival. Cox regressions addressed factors influencing BCR and MFS. BCR was defined as a PSA level of >0.2 ng/mL and rising, continence as the use of 0–1 safety pad/day, and potency as a five-item version of the International Index of Erectile Function score of ≥18.

RESULTS

The median follow-up was 36 months. After SRP, 42.0% of the patients experienced BCR, 15.9% developed metastasis, and 5.5% died from prostate cancer. Patients fulfilling the EAU guideline criteria were less likely to have positive lymph nodes (LNs) and had significantly better BCR-free survival (5-year BCR-free survival 73.9% vs 11.6%; P = 0.001). In multivariate analysis, low-dose-rate brachytherapy as primary treatment (P = 0.03) and presence of positive LNs at SRP (P = 0.02) were significantly associated with worse BCR-free survival. The presence of positive LNs or Gleason score >7 at SRP were independently associated with metastasis. The urinary continence rate at 1 year after SRP was 74%. Seven patients (12.7%) had complications ≥III (Clavien grade).

CONCLUSION

SRP is a safe procedure providing good cancer control and reasonable urinary continence. Oncological outcomes are significantly better in patients who met the EAU guideline recommendations.

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Editorial: SRP – a few good men

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The current management of recurrent disease after definitive treatment of a localized prostate cancer with radiation therapy (RT) or cryotherapy remains debatable. A substantial portion of patients treated with RT (20–50%) will experience biochemical recurrence. Androgen deprivation therapy has been the mainstay of therapy for this patient population, especially if there was concern about metastatic spread. As the initial experience with salvage radical prostatectomy (SRP) was highly morbid with poor functional outcomes, this did not gain strong acceptance as a recommended treatment method; however, with improved functional outcomes and fewer complications reported in recent series, SRP has once again become a viable alternative in select cases.

The rarity of the procedure makes it difficult to generate large-volume prospective studies on SRP, requiring us to depend on retrospective series. Chade et al. [1] published the largest series of patients undergoing SRP through a multicentre collaborative effort, and were able to identify 404 patients treated between 1985 and 2009; other large series were limited to 50–200 patients. In their systematic review of studies published between 1980 and 2011, Chade et al. [2] reported 5- and 10-year biochemical recurrence-free survival rates of 47–82% and 28–53%, respectively. This broad range of outcomes hints at the variable response of patients to SRP. Identifying the subset of patients who are most likely to benefit from SRP will therefore help tailor therapies for patients who have failed RT, cryotherapy or high-intensity focused ultrasonography.

As described by Mandel et al. [3], there are three sets of guidelines currently addressing patient selection for SRP. The NICE guidelines are the least specific, essentially mentioning SRP as an option for management without specifying specific criteria [4]. The European Association of Urology (EAU) and National Comprehensive Cancer Network guidelines are more specific, and help narrow the patient population to men with clinically localized recurrence (cT1–2), life expectancy of at least 10 years and a preoperative PSA level <10 ng/mL[5, 6]. The EAU guidelines are even more restrictive, limiting selection to men with Gleason ≤7 on prostate biopsy, although they do not specify whether that is before or after RT [5].

In their retrospective analysis of 55 patients treated with SRP between 2007 and 2012, Mandel et al. [3] compare the oncological outcomes of patients treated according to the EAU criteria (n = 32) and those treated without meeting the EAU criteria (n = 23). The 5-year biochemical recurrence-free survival rate was 48.7%, consistent with previous studies, as was the 5-year cancer-specific survival rate of 89%. Importantly, however, after stratification based on EAU criteria, the 5-year biochemical recurrence-free survival rates were drastically different: 73.9% in patients who met the EAU criteria and 11.6% in patients who did not. Patients who did not meet the EAU criteria were more likely to have Gleason score ≥8 (P = 0.08) tumours and pN1 (nodal metastatic) disease at the time of SRP (P = 0.04), which shows the ability of these criteria to select patients with localized disease recurrence. They also established that overall functional outcomes were acceptable after this procedure, with a postoperative urinary continence rate of 74%; none of the patients recovered potency, however, which is not surprising considering the high rate of preoperative erectile dysfunction and the non-nerve-sparing nature of the procedure [3].

In terms of complications, 12.7% of the patients had Clavien ≥ III complications requiring additional intervention. When complications do occur, they can be severe: three of the patients (5.5%) developed rectovesical fistulae and failed conservative management, progressing to fistula repair with omental flap, and two of the patients required permanent urinary diversion. There was no specification, however, regarding which subset of patients experienced these complications. The complication rate was acceptable, and consistent with recent reports of decreased complication rates with SRP [3].

While the study has its limitations as a retrospective review of a relatively small cohort, it is the first to analyse outcomes based on published guidelines criteria, and thereby helps to validate the subset of patients that will benefit from surgical intervention. Based on their findings, appropriately selected patients, those with evidence of truly localized recurrent disease after RT or high-intensity focused ultrasonography, can have significant oncological benefit with acceptable functional outcomes and without significant morbidity. The goal is not to perform SRP indiscriminately, rather to wait for a few good men.

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Thenappan Chandrasekar , and Christopher P. Evans
Department of Urology, University of California, Sacramento, CA, USA

 

References

 

1 Chade DC, Shariat SF, Cronin AM et al. Salvage radical prostatectomy for radiation-recurrent prostate cancer: a multi-institutional collaboration. Eur Urol 2011; 60: 205–10

 

2 Chade DC, Eastham J, Graefen M et al. Cancer control and functional outcomes of salvage radical prostatectomy for radiation-recurrent prostate cancer: a systematic review of the literature. Eur Urol 2012; 61: 961–71

 

3 MandelP, Steuber T, Ahyai S et al. Salvage radical prostatectomy for recurrent prostate cancer: verification of European Association of Urology guideline criteria. BJU Int 2015; 117: 55–61

 

4 Prostate cancer: diagnosis and treatment. NICE clinical guideline 175: Hearing before the National Institute for Health and Care Excellence (January 2014).

 

5 Heidenreich A, Bastian PJ, Bellmunt J et al. EAU guidelines on prostate cancer. Part II: treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol 2014; 65: 467–79

 

6 Mohler JL, Kantoff PW, Armstrong AJ et al. Prostate cancer, version 2.2014. JNCCN 2014; 12: 686–718.

 

 

Article of the week: Long-term study finds excellent outcomes after RARP

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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.

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

Long-term evaluation of survival, continence and potency (SCP) outcomes after robot-assisted radical prostatectomy (RARP)

Vincenzo Ficarra*†, Marco Borghesi*‡, Nazareno Suardi§, Geert De Naeyer*, Giacomo Novara†, Peter Schatteman*, Ruben De Groote*, Paul Carpentier* and Alexander Mottrie*

*OLV Robotic Surgery Institute, Aalst, Belgium, †University of Padova, Padova, ‡University of Bologna, Bologna, and §Vita-Salute University San Raffaele, Milan, Italy

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OBJECTIVE

• To report combined oncological and functional outcome in a series of patients who underwent robot-assisted radical prostatectomy (RARP) for clinically localised prostate cancer in a single European centre after 5-year minimum follow-up according to survival, continence and potency (SCP) outcomes.

PATIENTS AND METHODS

• We extracted from our prostate cancer database all consecutive patients with a minimum follow-up of 5 years after RARP. Biochemical failure was defined as a confirmed PSA concentration of >0.2 ng/mL.

• All patients alive at the last follow-up were evaluated for functional outcomes using the Expanded Prostate Cancer Index Composite (EPIC) and Sexual Health Inventory for Men (SHIM) questionnaires.

• Oncological and functional outcomes were reported according to the SCP system. Specifically, patients were classified as using no pad (C0), using one pad for security (C1), and using ≥1 pad (C2) (not including the prior definition).

• Patients potent (SHIM score of >17) without any aids were classified as P0 category; patients potent (SHIM score of >17) with use of phosphodiesterase type 5 inhibitorsas P1; and patients with erectile dysfunction (SHIM score of <17) as P2 category. Patients who did not undergo a nerve-sparing technique, who were not potent preoperatively, who were not interested in erections, or who did not have sexual partners were classified as Px category.

RESULTS

• The 3-, 5- and 7-year biochemical recurrence-free survival rates were 96.3%; 89.6% and 88.3%, respectively.

• At follow-up, 146 (79.8%) were fully continent (C0), 20 (10.9%) still used a safety pad (C1) and 17 (9.3%) were incontinent using ≥1 pad (C2).

• Excluding Px patients, 52 patients (47.3%) were classified as P0; 41 patients (37.3%) were classified as P1 and 17 patients (15.5%) were P2.

• In patients preoperatively continent and potent, who received a nerve-sparing technique and did not require any adjuvant therapy, oncological and functional success was attained by 77 (80.2%) patients.

• In the subgroup of 67 patients not evaluable for potency recovery (Px), oncological and continence outcomes were attained in 46 patients (68.7%).

CONCLUSIONS

• Oncological and functional success was attained in a high percentage of patients who underwent RARP at ≥5 years follow-up.

• Interestingly, this study confirmed that excellent oncological and functional outcomes can be obtained in the ‘best’ category of patients, i.e. those preoperatively continent and potent and with tumour characteristics suitable for a nerve-sparing technique.

 

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Editorial: Time to raise the bar in localised prostate cancer

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In this issue of BJUI, Ficarra et al. present the long-term (mean 81.3 months) follow-up of a case series of 183 men that underwent robot-assisted radical prostatectomy (RARP) at a single academic medical centre in Europe. To the authors’ credit, they report both cancer control and patient-reported outcomes, using well-known validated and reliable instruments to assess both urinary and sexual function. Like others before them, Ficarra et al. demonstrate that RARP is a safe and effective way to treat localised prostate cancer.

However, the question the study raises is not so much about the operation’s success rate but rather how success is defined in the first place. Throughout the prostate cancer literature, we have loosened definitions of successful urinary and sexual function to make RP more palatable to patients. In the present study, potency is effectively defined as a Sexual Health Inventory for Men (SHIM) score of >17 with or without the use of a phosphodiesterase type 5 (PDE5) inhibitor. Similarly, continence is defined as either no pad use or the use of a single pad ‘for security’. This approach certainly has face validity to us as clinicians. After all, PDE5 inhibitors are effective therapies for erectile dysfunction and the use of a single urinary liner certainly does not seem like a big deal. However, we need to consider this from the patient’s perspective. Both urinary pads and PDE5 inhibitors are costly to the patient and may represent an inconvenience and a potential embarrassment to many men. Is it really fair to tell men that they will be potent and/or continent after the operation, if they are going to require these additional interventions to achieve the desired state? I think not.

Going forward, we must set the bar higher if we are to be truly honest with our patients and optimise outcomes after RP. We must effectively ‘leave patients the way we found them’ with the critical difference being that they are now cancer-free. In other words, if a man was able to achieve an erection sufficient for intercourse preoperatively without the use of PDE5 inhibitors, he should only be considered potent postoperatively if he is in the same state, i.e. able to achieve an erection sufficient for intercourse without the use of a PDE5 inhibitor. The same holds true for urinary continence and the use of urinary liners. This will certainly make it more difficult to achieve the ‘trifecta’ but the reader should remember that the term is meant to imply ‘triple perfection’ and needing to use a PD5 inhibitor for sexual activity or having to wear a urinary pad, while acceptable to many patients, is certainly not perfect.

Some will say that I am insisting that the bar be set too high, that patients are willing to accept these reasonable but less than perfect definitions of success to be cured of their cancer. I acknowledge that there may be some validity to this argument in men with higher risk disease, where we know that cancer control and cure is necessary. However, I do not think the argument holds up in the case of men with low-risk disease, many of whom will never experience any symptoms of prostate cancer in their lifetimes and will not die of their disease if it were left untreated. In these patients, setting the bar higher would not only be more honest but it would probably increase the uptake of active surveillance and decrease overtreatment. In summary, while the use of more stringent definitions of success after RP may make our operations look ‘worse’, it will help our patients to set more realistic expectations, make more informed choices about treatment and ultimately to have better outcomes.

David F. Penson
Department of Urologic Surgery, Vanderbilt University, 2525 West End Avenue, Suite 1200, Nashville, TN, 37203, USA

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