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42
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3 Focal Ablative Therapy forLocalized Kidney Cancer
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83. Dreyfuss LD, Wells SA, Best SL, Hedican SP, Ziemlewicz TJ, Lubner MG, etal. Development of a risk-stratied approach for follow-up imaging after percutaneous thermal ablation of sporadic stage one renal cell carcinoma. Urology. 2019;134:148–53.
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86. Cornelis F, Marcelin C, Bernhard J-C. Microwave ablation of renal tumors: a narrative review of technical considerations and clinical results. Diagn Interv Imaging. 2017;98(4):287–97.
87. Liang P, Wang Y. Microwave ablation of hepa­tocellular carcinoma. Oncology. 2007;72(Suppl.
1):124–31.
88. Clark PE, Woodruff RD, Zagoria RJ, Hall MC. Microwave ablation of renal parenchymal tumors before nephrectomy: phase I study. Am J Roentgenol. 2007;188(5):1212–4.
89. Lin Y, Liang P, Yu X-l, Yu J, Cheng Z-g, Han Z-y, Liu F-y. Percutaneous microwave ablation of renal cell carcinoma is safe in patients with a solitary kid­ney. Urology. 2014;83(2):357–63.
90. Wells SA, Wheeler KM, Mithqal A, Patel MS, Brace CL, Schenkman NS.Percutaneous microwave abla­tion of T1a and T1b renal cell carcinoma: short- term efcacy and complications with emphasis on tumor complexity and single session treatment. Abdom Radiol. 2016;41:1203–11.
91. Aarts BM, Gomez FM, Lopez-Yurda M, Bevers RF, Herndriks J, Beets-Tan RG, et al. Safety and efcacy of RFA versus MWA for T1a renal cell
carcinoma: a propensity score analysis. Eur Radiol. 2023;33(2):1040–9.
92. Yu J, Zhang X, Liu H, Zhang R, Yu X, Cheng Z, etal. Percutaneous microwave ablation versus lapa­roscopic partial nephrectomy for cT1a renal cell car­cinoma: a propensity-matched cohort study of 1955 patients. Radiology. 2020;294(3):698–706.
93. Edd JF, Horowitz L, Davalos RV, Mir LM, Rubinsky B. In vivo results of a new focal tissue ablation technique: irreversible electroporation. IEEE Trans Biomed Eng. 2006;53(7):1409–15.
94. Deodhar A, Monette S, Single GW Jr, Hamilton WC Jr, Thornton R, Maybody M, etal. Renal tis­sue ablation with irreversible electroporation: preliminary results in a porcine model. Urology. 2011;77(3):754–60.
95. Tracy CR, Kabbani W, Cadeddu JA. Irreversible electroporation (IRE): a novel method for renal tis­sue ablation. BJU Int. 2011;107(12):1982–7.
96. Diehl SJ, Rathmann N, Kostrzewa M, Ritter M, Smakic A, Schoenberg SO, Kriegmair MC. Irreversible electroporation for surgical renal masses in solitary kidneys: short-term interven­tional and functional outcome. J Vasc Interv Radiol. 2016;27(9):1407–13.
97. Canvasser NE, Sorokin I, Lay AH, Morgan MS, Ozayar A, Trimmer C, Cadeddu JA. Irreversible electroporation of small renal masses: suboptimal oncologic efcacy in an early series. World J Urol. 2017;35:1549–55.
98. Potters L, Kavanagh B, Galvin JM, Hevezi JM, Janjan NA, Larson DA, etal. American Society for Therapeutic Radiology and Oncology (ASTRO) and American College of Radiology (ACR) practice guideline for the performance of stereotactic body radiation therapy. Int J Radiat Oncol Biol Phys. 2010;76(2):326–32.
99. Ponsky LE, Mahadevan A, Gill IS, Djemil T, Novick AC. Renal radiosurgery: initial clinical experience with histological evaluation. Surg Innov. 2007;14(4):265–9.
100. Ponsky LE, Crownover RL, Rosen MJ, Rodebaugh RF, Castilla EA, Brainard J, etal. Initial evaluation of Cyberknife technology for extracorporeal renal tissue ablation. Urology. 2003;61(3):498–501.
101. Siva S, Pham D, Gill S, Corcoran NM, Foroudi F. A systematic review of stereotactic radiotherapy ablation for primary renal cell carcinoma. BJU Int. 2012;110(11 Pt B):E737–E43.
102. Siva S, Ali M, Correa RJ, Muacevic A, Ponsky L, Ellis RJ, etal. 5-year outcomes after stereotactic abla­tive body radiotherapy for primary renal cell carci­noma: an individual patient data meta-analysis from IROCK (the International Radiosurgery Consortium of the Kidney). Lancet Oncol. 2022;23(12):1508–16.
103. Sun MR, Brook A, Powell MF, Kaliannan K, Wagner AA, Kaplan ID, Pedrosa I.Effect of stereo­tactic body radiotherapy on the growth kinetics and enhancement pattern of primary renal tumors. AJR Am J Roentgenol. 2016;206(3):544–53.
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104. Olweny EO, Park SK, Tan YK, Best SL, Trimmer C, Cadeddu JA. Radiofrequency ablation versus partial nephrectomy in patients with solitary clini­cal T1a renal cell carcinoma: comparable oncologic outcomes at a minimum of 5 years of follow-up. Eur Urol. 2012;61(6):1156–61.
105. Thompson RH, Atwell T, Schmit G, Lohse CM, Kurup AN, Weisbrod A, et al. Comparison of par­tial nephrectomy and percutaneous ablation for cT1 renal masses. Eur Urol. 2015;67(2):252–9.
106. Katsanos K, Mailli L, Krokidis M, McGrath A, Sabharwal T, Adam A.Systematic review and meta­analysis of thermal ablation versus surgical nephrec­tomy for small renal tumours. Cardiovasc Intervent Radiol. 2014;37:427–37.
107. Best SL, Park SK, Youssef RF, Olweny EO, Tan YK, Trimmer C, Cadeddu JA. Long-term out­comes of renal tumor radio frequency ablation stratied by tumor diameter: size matters. J Urol. 2012;187(4):1183–9.
108. Johnson BA, Sorokin I, Cadeddu JA.Ten-year out­comes of renal tumor radio frequency ablation. J Urol. 2019;201(2):251–8.
109. Psutka SP, Feldman AS, McDougal WS, McGovern FJ, Mueller P, Gervais DA. Long-term oncologic outcomes after radiofrequency ablation for T1 renal cell carcinoma. Eur Urol. 2013;63(3):486–92.
110. Tanagho YS, Roytman TM, Bhayani SB, Kim EH, Benway BM, Gardner MW, Figenshau RS. Laparoscopic cryoablation of renal masses: single-center long-term experience. Urology. 2012;80(2):307–14.
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112. Caputo PA, Zargar H, Ramirez D, Andrade HS, Akca O, Gao T, Kaouk JH. Cryoablation versus partial nephrectomy for clinical T1b renal tumors: a matched group comparative analysis. Eur Urol. 2017;71(1):111–7.
113. Nielsen TK, Lagerveld BW, Keeley F, Lughezzani G, Sriprasad S, Barber NJ, et al. Oncological out­comes and complication rates after laparoscopic­assisted cryoablation: a European Registry for renal Cryoablation (EuRECA) multi-institutional study. BJU Int. 2017;119(3):390–5.
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The Patient’s Perspective: What Does thePatient Want?
JonathanFainberg, BernadetteM.Greenwood, AliKasraeian, andBehfarEhdaie
4

Introduction

Prostate cancer is the most common (non­cutaneous) cancer among American men affect­ing one in eight men in their lifetime [1]. According to the American Cancer Society, 288,300 men will be diagnosed with prostate cancer in 2023, and, unfortunately, more than
Pre-chapter note: This section of our chapter is dedicated to the Patient Advisory Council of the Focal Therapy Society (formerly under the International Laser Network and absorbed by the Focal Therapy Society in October
2020). These patients have participated in meetings and provided important feedback for over a decade. The group has changed over the years and has been comprised of physicians, businessmen, athletes, and attorneys, and was initially led by a health actuary. This section will speci­cally address what they believe patients need when con­sidering focal therapy as a rst-line treatment for prostate cancer.
J. Fainberg · B. Ehdaie (*) Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA e-mail: fainberj@mskcc.org; ehdaieb@mskcc.org
B. M. Greenwood Department of Radiologie and Nuclear Medicine, Radboud University Medical Center, Nijmegen, Netherlands
HALO Diagnostics, Indian Wells, CA, USA e-mail: bernadette@halodx.com
A. Kasraeian Kasraeian Urology, Jacksonville, FL, USA e-mail: alikasraeian@kasraeianurology.com
34,700 will die of prostate cancer this year [1]. Although prostate cancer screening has been shown to decrease prostate cancer-specic mor­tality by more than 50% since the Prostate Specic Antigen (PSA) test was rst introduced in the late 1980s, its widespread use remains one of the most controversial issues in the world of urologic oncology, urology, in general, and pub­lic health [2–4]. The management of organ-con­ned prostate cancer is similarly complex as not all diagnosed cancers require immediate treat­ment, while for some, early detection and more aggressive management are necessary to opti­mize the possibility of cure. The conundrum for the gentlemen diagnosed with prostate cancer and the urologists called to the task of their care lies not only in the decision of who to treat and when, but also how. Herein lies the art in the management of prostate cancer as many different alternatives can and should be considered, each with its own unique benets and individual risks. The elegance of this conversation is truly based on the concept of a personalized approach to prostate cancer care.
Deciding “what to do?” is a challenging pro­cess for a man recently diagnosed with prostate cancer. Often, he has had no symptoms, no warn­ing that “something was wrong,” and is likely to be overwhelmed by the possible urinary, sexual, and bowel-related side effects associated with the therapeutic choices presented to him. Ultimately, most men diagnosed with prostate cancer are looking for a way to best treat their cancer, while
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024 T. J. Polascik et al. (eds.), Imaging and Focal Therapy of Early Prostate Cancer,
https://doi.org/10.1007/978-3-031-66754-1_4
47
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J. Fainberg et al.
simultaneously doing their best to nd an alterna­tive that will minimize the possible impact of that treatment on their quality of life. This dilemma continues to grow more challenging for both patients and their urologists/physicians as long­term studies, such as the recently published 15-year ProtecT trial (comparing active observa­tion, radical prostatectomy, and radiotherapy), show that prostate cancer-specic mortality remained low regardless of the treatment assigned. Thus, the authors concluded that “the choice of therapy involves weighing trade-offs between benets and harms associated with treat­ments for localized prostate cancer.” [5] Keeping all of this in mind is of utmost importance when beginning any conversation regarding the man­agement of any man newly diagnosed with pros­tate cancer. The support and participation of family members and trusted loved ones should be encouraged and appreciated.
Once the specics regarding the stage, grade, and aggressiveness of his prostate cancer have been reviewed and the appropriate work-up underway, discussions regarding management options should begin, if they have not already. The patient must have a clear understanding of his disease and the role that this understanding will play in his decision-making regarding the management of his prostate cancer. The decision­making process begins with a consideration of active surveillance versus treatments aimed at a denitive cure. If the patient’s prostate cancer does not meet the criteria for active surveillance (and/or if he expresses strong opposition to the idea despite a detailed discussion of all the risks, benets, and alternatives), then the focus should turn toward more curative treatment options.
When initially diagnosed with prostate cancer, the initial choice a man must make is one of surveil­lance versus treatment. If treatment is decided, when reviewing the various denitive treatment options for prostate cancer, the patient must decide either in favor of a surgical or ablative approach to treat his prostate cancer or rather a radiation-based option for treatment, such as brachytherapy or external beam radiotherapy. If he prefers an ablative approach, is he
a candidate for focal therapy? If so, are the focal therapy options available of interest to him? It is important for the patient to have a clear understand­ing of the risks, benets, and alternatives to all the options available, including those specic to focal therapy. The urologist, as well as any physician engaged in these conversations, must always be empathetic and compassionate to the specic con­cerns and the specic goals that are important to the individual challenged to make this difcult decision.

Informed Consent

Given the current status of Focal Therapy in the United States, patient education, discussion of alternatives, and the entire informed consent pro­cess are critical components of the pre-ablation workup. The Informed Consent Document (ICD), whether for clinical performance of focal therapy or performance under IRB-approved research protocol, is the perfect teaching tool to fully dis­close all aspects of the treatment being offered as well as other alternatives. Risks and benets are documented, fully disclosed, and nally, dis­cussed. Patients should have all of their questions answered prior to signing the informed consent and a copy should be provided to them for future reference. The “Teach Back Method” may also be used to identify any gaps in understanding or clarify important points.
Patients, spouses, and family members of men with newly diagnosed prostate cancer can be overwhelmed with the diagnosis and treatment options available. Often, the shock of their diag­nosis sends them into a fact-nding frenzy that leaves them more confused than when they began, ending up in a state of “analysis paraly­sis.” We have a duty to share our knowledge and experience to help them condently face their treatment decisions armed with evidence-based medicine. Strongly acknowledging the current standard of care methods for the treatment of the disease is crucial and needs to be done thoroughly and transparently.
4 The Patient’s Perspective: What Does thePatient Want?
49
What Does thePatient Want?
Simply, and as previously discussed, the majority of men diagnosed with prostate cancer are engaged in a dual quest: they seek the most effec­tive therapeutic approach to manage their malig­nancy, while concurrently aiming to minimize the treatment’s impact on their overall quality of life. This dilemma frequently constitutes a com­plex, nuanced, and arduous decision-making process.
In the face of a prostate cancer diagnosis, patients are confronted with tough decisions regarding their treatment options. These deci­sions can be overwhelming and anxiety- inducing, as patients are not only grappling with their health but also considering the potential short­and long-term consequences of their chosen treatment. Prostate cancer is a complex disease that requires careful consideration of various fac­tors when determining the most appropriate treat­ment approach. Patients must weigh the potential risks and benets of each treatment option, tak­ing into account factors such as their age, overall health, tumor characteristics, and personal preferences.
When discussing ablative options with patients, a focal therapy practitioner must engage the patients in the decision-making process and explain the nuances of these decisions, as many patients interested in focal therapy are well researched and opinionated. Patients want infor­mation about all energy sources, imaging guid­ance, and surgical approaches. While most patients recognize that there are currently no ran­domized controlled trials (RCTs) comparing various energy sources, they seek to understand the mechanisms of action of each, their benets,
and their drawbacks. They want comparisons to other options in the context of their individual situation and are interested in statistics on both oncologic and functional outcomes. With recur­rence anticipated with focal treatments of pros­tate cancer, retreatment options must be discussed candidly. Many patients request repeat focal ther­apy when facing recurrence, whether or not it is in-eld or out-of-eld, to avoid the morbidity of whole gland treatment.
The ideal focal therapy discussion is patient­centered and involves three meaningful out­comes: cancer control, maintenance of sexual function, and urinary function. This “trifecta” of excellent outcomes is the goal of most focal ther­apy providers and the outcome that the patients are seeking, regardless of tumor location, size, and energy modality utilized. Balancing cancer control and quality of life is of paramount impor­tance; it is about arriving at a balance between the cancer’s biology, the patient’s priorities, and the tools the provider has to best achieve these outcomes.
As most patients do consider the “trifecta” outcome the priority during the treatment of their localized prostate cancer, how often can we attain these excellent oncologic and functional out­comes? While minor differences exist between energy modalities in terms of oncologic and functional outcomes, most studies report good oncologic outcomes with excellent functional results during follow-up, in both urinary and sex­ual domains (Table 4.1). Patient selection, a detailed and thorough pre-operative workup, suc­cessful ablation with care taken to margins and tissue destruction, and detailed follow-up are all crucial to achieving this “Trifecta” outcome, regardless of the energy choice selected [6].
50
Table 4.1 Summary of outcomes after partial gland ablation
Percentage of
patients with Number of
Modality
Thermal
HIFU 625 84 75 88 15% new ED83% pad-free
Cryotherapy 301 62 N/A 95 No change Improved
FLA 98 N/A 69 N/A No change No change Feller etal.
RFA 21 N/A 76 N/A No change No change Taneja etal.
Nonthermal
VTP 206 0 49 94 No change No change Azzouzi
Brachytherapy 354 17 N/A N/A N/A N/A King etal.
IRE 25 28 72 8 No new EDNo change Murray etal.
ED erectile dysfunction, EPIC Expanded Prostate Cancer Index Composite, FLA focal laser ablation, HIFU high­intensity focused ultrasound, IRE irreversible electroporation, N/A not available, R FA radio frequency ablation, VTP vascular-targeted photodynamic therapy Adapted from: Fainberg, etal. A systematic review of outcomes after thermal and nonthermal partial prostate gland ablation 2021
patients
164 80 N/A 96 18% new ED0% new
149 89 N/A 83 14% new ED0.6% new
111 32 93 89 22% new ED3% new
122 90 N/A 91 16% new EDNo change Shah etal.
107 24 48 N/A N/A N/A Barret etal.
25 56 84 N/A No change No change Lepor etal.
18 N/A 28 66 No change N/A Elkhoury
20 N/A 80 90 No change No change Orczyk etal.
21 0 76 87 No change No change Taneja etal.
63 86 76 89 Mild
clinically
signicant
disease
Percentage of patients with negative follow-up biopsy
Failure­free survival (%)
Erectile function
decrease in scores (EPIC)
Urinary function Reference
at 3 y
incontinence
incontinence
incontinence
ow rates
No change van de Bos
J. Fainberg et al.
Guillaumier etal. (2018)
Mistry etal. (2017)
Hanna etal. (2018)
Rischmann etal. (2017)
Bianco etal. (2018)
(2019)
(2018)
(2018)
(2015)
etal. (2018)
(2018)
(2018)
etal. (2015)
(2018)
(2018)
(2016)
etal. (2018)
4 The Patient’s Perspective: What Does thePatient Want?

Why Focal Therapy?

Prostate cancer presents a multifaceted clinical challenge affecting millions of men globally [7]. Upon diagnosis, patients encounter a diverse array of treatment modalities, including surgery, radiation therapy, and androgen deprivation ther­apy. Among these, focal therapy has garnered increasing interest as a targeted and minimally invasive option, particularly for those with low­to- intermediate risk, localized disease.
Why focal therapy: a patient’s perspective
[Given this chapter’s patient-centered focus, we wanted to include an interview with a Patient Advisory Council member, Mr. “D”].
What drew me to focal [therapy], and what would plausibly draw most men, is a pres­ervation of options. This strong benet is not offered by either of the whole-gland therapies. Of course, surgery is a profound commitment with both short- and long­term complications. Radiation also repre­sents a commitment as surgery seldom follows. I was not convinced that the oncological control of focal [therapy] was worse than surgery or radiation. I knew recurrence was a possibility in direct conversations with the surgical team. At 53, rst diagnosed at 50, I have priori­tized sexual function and oncological con­trol nearly equally. Others may question that approach. However, this is another dimension on which the preservation of future options through focal therapy under­pinned my decision for it. I appreciate that sufferers of other more aggressive and dan­gerous cancers seldom have short-term options. I feel quite fortunate to have had options. As a younger prostate cancer suf­ferer, with 20 working years ahead of me, I felt strongly compelled to preserve sexual-
51
ity. The least of the priorities was urinary continence. Emotional well-being is a strong priority for me and that undergirds much of my attraction to focal therapy. Early post­diagnosis, I was assured bluntly that the only path was prostatectomy, with sexuality and continence to be addressed later. I feared regret and I was vexed by the lack of intellectual curiosity of two urologists and their unwillingness to cede any complexity on treatment decisions. Focal therapy was introduced to me in a transformative con­versation. Understandably, providers can­not offer guarantees long-term, but, for the rst time in my journey, apprehensions were acknowledged and some authorship was offered. I felt dignity. I strongly believe that focal oncological control was on-par with all available meth­ods and I emerged whole. As I understand it, the [treatment] is narrow enough to address cancer and preserve nearby struc­tures. More broadly, options were pre­served and I felt a real sense of participation in my treatment and will have focal [ther­apy] as many times as necessary and per­mitted. I cannot endorse this technology more. I have not the slightest reservation and would eagerly describe it to any man who asked my opinion. Research scientists offer a glimpse of the future with this effec­tive and dignied treatment.—Mr. D.
Focal therapy uniquely addresses the balance between effective cancer control and quality-of­life preservation by targeting only the cancer­affected portion of the prostate. Focal therapy targets only the cancerous part of the prostate, sparing the rest of the gland, and thereby reduc­ing the risk of unwanted side effects. Simply, the theory guiding the concept of focal therapy is that the more prostate you preserve, the more func­tion you preserve. This theory is well rooted in the treatment of other solid-organ malignancies,
52
J. Fainberg et al.
where organ-sparing surgery is routine in clinical practice, given the lack of disgurement (lumpec­tomy versus mastectomy) or deterioration of function (partial nephrectomy versus radical nephrectomy) that organ sparing surgery can offer. This selectivity offers signicant advan­tages, notably minimizing urinary and sexual side effects commonly associated with traditional whole-gland treatments like radical prostatec­tomy and radiation therapy. Focal therapy thus emerges as a compelling intermediate between active surveillance—often seen as an approach of minimal intervention—and more aggressive radi­cal treatments, effectively positioning itself as a viable rst-line strategy for specic cases of localized, and especially unilateral, organ­conned prostate cancer.
Technologically, focal therapy benets from advancements in imaging, advanced diagnostic, and interventional techniques. The use of MRI and targeted biopsies allows for the precise iden­tication of tumor foci, optimizing the treatment plan. The evolving armamentarium of focal modalities, including (but not limited to) high­intensity focused ultrasound (HIFU), cryother­apy, focal laser ablation (FLA), irreversible electroporation (IRE), and photodynamic therapy (PDT), provides clinicians the exibility to cus­tomize therapy based on tumor characteristics, including size and location. These technologies not only enhance the accuracy of treatment deliv­ery but also facilitate real-time monitoring and follow-up, crucial elements for gauging efcacy and patient outcomes.
For patients and urologists alike, focal therapy is redening the therapeutic landscape for local­ized prostate cancer by offering a nuanced
approach that aims to bridge the gap between active surveillance and more aggressive radical treatment options. Its patient-centric focus on minimizing adverse effects while achieving tar­geted cancer control places it as a highly appeal­ing option, particularly for those with targetable, localized diseases. However, its integration into standard care protocols will need further and more comprehensive long-term data in order to conrm, to a greater extent, its continued long­term safety and efcacy.

References

1. Key statistics for prostate cancer: prostate cancer facts. Prostate Cancer Facts | American Cancer Society,
https://www.cancer.org/cancer/types/prostate- cancer/ about/key- statistics.html.
2. Kelly SP, Rosenberg PS, Anderson WF, etal. Trends in the incidence of fatal prostate cancer in the United States by race. Eur Urol. 2017;71(2):195–201. https://
doi.org/10.1016/j.eururo.2016.05.011.
3. Smith DS, Catalona WJ.The nature of prostate can­cer detected through prostate specic antigen based screening. J Urol. 1994;152(5 Pt 2):1732–6.
4. Tidd-Johnson A, Sebastian SA, Co EL, et al. Prostate cancer screening: continued controver­sies and novel biomarker advancements. Curr Urol. 2022;16(4):197–206. https://doi.org/10.1097/
CU9.0000000000000145.
5. Hamdy FC, Donovan JL, Lane JA, etal. Fifteen-year outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med. 2023;388(17):1547–58.
https://doi.org/10.1056/NEJMoa2214122.
6. Fainberg JS, Al Hussein Al Awamlh B, DeRosa AP, Chesnut GT, Coleman JA, Lee T, Ehdaie B.A system­atic review of outcomes after thermal and nonthermal partial prostate ablation. Prostate Int. 2021;9:169.
7. Prostate cancer—statistics. Cancer.Net, 4 May 2023, www.cancer.net/cancer- types/prostate- cancer/
statistics#.
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