Advanced prostate cancer management by urologist: a real-life national survey in Brazil

doi:10.21203/rs.3.rs-5197321/v1

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Advanced prostate cancer management by urologist: a real-life national survey in Brazil

https://doi.org/10.21203/rs.3.rs-5197321/v1

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Purpose: To address key challenges of treating advance prostate cancer (APC) faced by urologists, a nationwide survey was conducted. Although androgen receptor pathway inhibitors (ARPis) and other systemic agents have become standard treatments of APC, it is unclear how urologists have integrated these into their practice.

Methods: A cross-sectional, closed 27-item was developed to investigate the impact of regional aspects, additional training and regulatory barriers on management of advanced prostate cancer. The target respondents were urologists who are members of the Brazilian Society of Urology (SBU). Our study evaluated various aspects of these new therapeutic strategies in a country with limited healthcare resources.

Results: Of 557 respondents, 465 completed the survey. Most 287 (58%) worked in both private and public systems and 19% were urooncologists and 7% were female. ARPIs prescription analysis showed that 10% prescribe in the more resource-limited regions (center-north vs 24% in south/southeast). Urooncologists were significantly more inclined to prescribe ARPIs, and ADT for radiotherapy compared to general urologists (43%vs17%, 38%vs18%, respectively, p < 0.001 for both). While 76% of urologists reported treating metastatic patients, less than 35% prescribed ADT. Conversely, 9 (1.6%) reported prescribing ARPIs without medical or regulatory concerns. Sampling limitations of online surveys are possible.

Conclusion: Despite increasing evidence favoring use of ARPIs, this study provides insights into barriers on the management of advanced prostate cancer. Wider dissemination of updated education in new hormonal therapies may help to bridge this gap.

Prostatic Neoplasms

Castration-Resistant

Hormonal Antineoplastic Agents

Health Care Surveys

Business

workforce.

Prostate cancer (PC) is the most commonly diagnosed non-cutaneous cancer in men worldwide, with an estimated 1.4 million new cases in 2020 [1]. In Brazil, the National Cancer Institute (INCA) estimates approximately 71,730 new cases in 2023 and 15,841 deaths attributed to PC, reflecting an estimated risk of 67.86 new cases and mortality rate of 15.30 deaths per 100,000 men [2]. Moreover, between 40% and 54% of men with PC will be candidate for androgen deprivation therapy (ADT) use at some point along their treatment trajectory, whether in the localized setting, associated with radiation therapy (RT) as a primary or salvage treatment, or in advanced disease [3, 4].

Worldwide, fifteen per cent of all PC cases are diagnosed as advanced, and ADT has long been established as the primary treatment modality in this setting [5]. Since the studies of Huggins and Hodges in 1940s, the treatment landscape of advanced PC has changed rapidly in the last decades, with the emergence of new classes of proven effective agents that have been brought to early scenarios. In a timeline of this changes, we had the development of first-generation anti-androgens like bicalutamide, flutamide and nilutamide (non-steroidal) and cyproterone (steroidal) provided promising results by inhibiting testosterone's ability to fuel cancer growth [6]. Luteinizing hormone-releasing hormone agonists (LHRHa), such as leuprolide and goserelin, and antagonists like degarelix, further advanced treatment by directly reducing testosterone production [7]. Upfront chemotherapy with docetaxel has been demonstrated to improve survival in addition to ADT as first line therapy in metastatic PC [8, 9]. Furthermore, the arrival of Abiraterone, an androgen synthesis inhibitor and the advent of new androgen receptor pathway inhibitors (ARPis), including enzalutamide, apalutamide, and darolutamide, provided more effective options, capable of more precisely targeting androgen receptors [10-12], improving overall survival when used in many scenarios.

The progression of PC to advanced stages may precipitate the transfer of care from the urologist to clinical oncologists (COs). Nowadays, the contemporary landscape following the endorsement of novel oral medications has transformed the management of advanced PC in both castration-sensitive and castration-resistant settings. These changes, allied to better diagnostic methods, new therapies and better knowledge of tumor biology, enables urologists the possibility to extend their care continuum, treating patients not merely for localized disease but also through more advanced stages of their condition [13-15]. Undoubtedly, the decision to prescribe hormonal therapy is influenced by a multitude of factors, including the practitioner's engagement, the context of their practice (whether academic, public, or private), ongoing education and the assimilation of updated guidelines, sequencing of medications, as well as side effects profiles [16]. Nevertheless, it should be acknowledged that administrative limitations, stipulated by funding bodies encompassing both public and private sectors, may dictate prescribing privileges and, therefore create a bureaucratic barrier to urologists that want to keep managing these patients.

Although androgen receptor pathway inhibitors (ARPis) and different classes of systemic agents have become standard of care in the treatment of advanced prostate cancer, it is unclear how urologists have modified their practice to incorporate these advances. Therefore, fundamental questions about prescribing practices, access to treatments and knowledge remain unanswered. To better understand the Brazilian scenario in this matter, we conducted a national online anonymous survey to assess Brazilian urologists' interest and difficulties in prescribing hormonal therapy for advanced PC.

The primary outcome was to identify the barriers to the clinical use and prescription of androgen deprivation therapies (ADT) and ARPIs. The secondary outcome was to identify the differences between general urologists and as well as regional disparities.

Study design

A comprehensive 27-item SurveyMonkey® (California, USA) inventory was designed according to Checklist for Reporting Results of Internet E-Surveys (CHERRIES) guidelines and disseminated electronically via e-mail to all 5500 urologists registered by the Brazilian Society of Urology (SBU). The instrument aimed to evaluate the respondents' knowledge regarding the application of ADT, definitions and management protocols in the prevailing contexts of advanced PC, specifically in the non-metastatic (M0) and metastatic (M1) stages encompassing a broad spectrum of clinical practices and theoretical understandings. The process of data submission was scheduled from September to November 2023.

The questionnaire comprised a variety of variables, including demographic information (8-item), years of professional practice (1-item), specialized training in urologic oncology (4-item), and current understandings of biochemical recurrence (BCR) and management (6-item). It also probed into the utilization of imaging technologies (2-item), clinical management strategies for M0 and M1 APC (5-item) and the respondents' interest levels in these areas of study (1-item). Only one response per IP address was allowed.

Statistical analysis

Statistical analyses were performed using SPSS 29, and Chi-squared and Fisher's exact tests were used. A p-value of less than 0.05 was considered statistically significant.

Ethics

The research protocol received approval from an institutional ethics committee affiliated with the primary author (CAAE:73402223.0.0000.0121). This study adhered to the guidelines for obtaining consent and electronic assent from research participants within a virtual environment, as outlined in Circular Letter nº 23_2022 National Health Council – Brazil (CONEP), in addition to complying with prevailing ethical standards and legislation.

Participants demographics

Between September 1^st to November 30, 2023, a total of 557 responders initiated the survey, and 465 completed all questions, representing around 10% of the urologists in Brazil. All the responses were evaluated and were included at the database. Among them, 370 (69.6%) described themselves as general urologists, 102 (19%) as uro-oncologists and 52 (9.8%) were dedicated to another subspecialty, but also managed uro-oncology patients. Responders not practicing urologic oncology (1.7%) were excluded of the analysis. Seventy per cent of all participants reported not having additional training after residency, but among 102 (19%) uro-oncologists, 75.5% had pursued further education (57.8% fellowship, 28.3% holding master’s degree, 25.5% PhD degree and 14.7% having completed both a fellowship and a PhD degree) (Supplementary files).

As of 2024, women represent 4% of the urology workforce in Brazil. In this study, 7.2% of the respondents were female urologists. The population characteristics are described on infographics, along with a comparison between global ADT prescribing and new drugs. (Figure 1).

Comparison of the management between different regions of Brazil

The proportion of uro-oncologists varies considerably among regions, with the highest concentration in São Paulo (22.4%) and the lowest in the North (7.7%). There is a predominant male representation among urologists across all regions. The experience of professionals also differs, with the majority having more than 10 years of practice, especially in the Central-West (71.5%) and the Southeast (67.2%) regions.

The majority of survey participants work in both public and private sectors. A minority of urologists are exclusive to only one sector.

During residency, most urologists managed metastatic patients. The use of ARPi was relatively low across all regions, with the highest usage in the Southeast (20.8%) and São Paulo (18.6%).

In current practice, the prescription of LHRHa is most prevalent in São Paulo (47.8%) and the South (38.3%). The prescription of first-generation antiandrogens is most common in the South (42.9%) and less frequent in the Northeast (26%). The prescription of ARPi is highest in the Southeast (27.8%) and São Paulo (23%), but low in the North (7.7%) and Central-West (7.1%). Additionally, urologists who manage more than 2 biochemical recurrence (BCR) patients per month are relatively uncommon, with the highest incidence observed in the Southeast (13.9%) and Central-West (14.3%) regions.

Comparison of the management between general urologist and uro-oncologists

Most of uro-oncologists practice in bigger cities with population >500,000 inhabitants (84.2% vs. 57.2% among general urologists, p<0.001); they attend more oncologic patients per month and are more likely to follow-up the patients after primary treatment for PC (Table 2).

Although 64.7% reported having been trained during residency, merely 41.3% currently prescribe ADT after residency. Notably, 33% of the urologists reported not seeing metastatic patients in everyday practice. On the other hand, despite only 15.3% have been trained to prescribe ARPi, 22.4% currently prescribe ARPi in their practice. Prescription of ADT is higher among uro-oncolgists compared to general urologists: 49.5% prescribe LRRHa (vs. 32.2%) and 43% prescribe ARPi (vs. 17.6%).

When asked about management decision in localized PC setting, 92.7% of the urologists responded that they were responsible for the clinical decision, while 5% of them participate in shared decisions on tumor boards. Also, 97.9% of the participants demonstrated preference to perform radical prostatectomy in this scenario instead of RT (2.2%) and 91.6% of the urologists continue to follow-up the patients after surgery, with no differences between general urologists and uro-oncologists.

When RT is indicated, 88% of the urologists continue to follow-up patients, most of them (61.3%) together with the radiation oncologist and the number is higher among uro-oncologists (95.3% vs. 86.8%, p=0.04). About taking part in the indication of ADT in patients who undergo RT, only 35.5% of the urologists participate on decision making, alone (13.6%) or in conjunction with radiation oncologists (21.9%); and this therapeutic decision rests then with CO (41.7%), radiation oncologist (10.8%) or both (6.5%). Moreover, ADT is most often prescribed by CO (66.2%).

In BCR setting, 58.7% of the participants have PET-PSMA available and 29% use it to re-stage more than half (18.1%) or all (11%) the patients; only 17.6% reported never using it. Also, in this scenario, 90.8% of the urologists continue participating in therapeutic decisions, most of them (57%) together with the CO. And regarding M0 castration-resistant prostate cancer (CRPC) patients, most urologists (63.7%) refer the patient to oncologists for joint decision-making.

ADT pitfalls: Regulatory barriers, access limitations, and pharmacological complexities.

The leading reasons cited for both therapies were remarkably similar, with the bureaucratic complexity of the medication dispensation process being paramount. The percentage of urologists encountering these barriers when prescribing LHRHa ranges from 35.6% in São Paulo to 73.7% in the North. Regarding the prescription of ARPIs, no significant regional variations were observed. Concerns related solely to the clinical use of LHRHa and ARPIs, such as managing side effects and determining appropriate dosages, are less prevalent but still notable. In the Northeast, for example, 47.1% of urologists cited clinical use concerns for LHRHa, the highest among all regions. For ARPIs, these concerns were reported by 17.7% of urologists in the Northeast, with lower percentages in other regions such as São Paulo (7.5%) and the South (7.4%) (Supplementary files).

Specifically, 51.9% of general urologists and 39.5% of uro-oncologists indicated that regulatory and access issues were their primary barriers to prescribing LHRHa. Similarly, both groups faced access and regulatory barriers when prescribing ARPIs. Additionally, 25.3% of general urologists reported concerns related to the clinical use of LHRHa, compared to 15.8% of uro-oncologists. For ARPIs, 63.1% of general urologists and 50% of uro-oncologists expressed similar concerns (Supplementary file).

The prescription rates for LHRHa and ARPIs were notably low, with only 170 urologists (30.5%) prescribing LHRHa and 11 (3%) prescribing ARPIs. Referrals to CO within their professional network were also notable. Specifically, 97 urologists (17.4%) referred patients to oncologists for LHRHa treatment, and 124 urologists (21.2%) did so for ARPi prescriptions (Table 3).

The therapeutic landscape for advanced prostate cancer (PC) has rapidly evolved, with intensified treatment protocols now standard in earlier disease stages, including metastatic castration-sensitive (mCSPC) and non-metastatic castration-resistant PC (nmCRPC) [17-19].

Novel therapies, less toxic than chemotherapy, have reshaped the roles of urologists, clinical oncologists, and radiation oncologists in managing advanced PC [20]. Despite this, only one-third of urologists are involved in the follow-up care of advanced PC patients, with referral patterns varying based on training, practice setting, and additional uro-oncology education. Urologists are encouraged to continue managing patients throughout the disease's advanced stages.

Our findings reveal that 35.27% and 22.89% of respondents lacked training in prescribing LHRH antagonist/agonists and non-steroidal anti-androgens, respectively. Furthermore, 84.73% reported not receiving training in the prescription of ARPi during their urology residency Even in scenarios of neoadjuvant and adjuvant to RT in localized setting, only 18.71% of urologists undertake the responsibility of prescribing it. Importantly, it must be underscored that approximately 70% of the participants concluded their residency training more than a decade ago, at a juncture when these advanced therapeutic options were not yet introduced.

The predominant reasons cited for the reluctance to prescribe ADT were associated with the practice setting, which either prohibits urologists from prescribing ADT or necessitates collaboration with CO or were related to the bureaucratic challenges involved in the prescription of ADT. Despite these challenges, in several Brazilian reference centers, urologists continue to manage ADT. However, there exists considerable confusion regarding the authorization and restrictions on prescribing ADT within both public and private health insurance plans. This confusion is partly due to historical policy changes: on August 20th, 2007, the Ministerio da Saude (Brazilian Ministry of Health) issued Portaria No. 467, mandating that the treatment of metastatic, recurrent, or locoregional advanced PC should be exclusively managed by CO. This directive was subsequently repealed by Portaria No. 1,945 on August 27, 2009. Consequently, there is currently no Brazilian legislation that prohibits urologists from prescribing ADT to their patients, a provision affirmed by the Ministerio da Saude (Brasilia – Brazil) Actually, managing prostate cancer and its treatment options, in all possible stages, is part of the urological core curriculum (“Matriz de Competências”), stablished by the Minister of Education [21].

Since the use of ARPi is being brought to early settings, including promising trials of its use as neoadjuvant and adjuvant therapies of localized disease, the need of urologists understanding PC medical treatment became paramount [22]. It’s acknowledged that the recommended approach of advanced PC patients is best achieved through the involvement of multidisciplinary teams. This collaborative approach ensures the provision of evidence-based decisions throughout all stages of the treatment process [18]. However, in our study, only 5.59% of the urologists participate on tumor boards to discuss diagnostic and treatment options. It’s important to highlight that the establishment and maintenance of these multidisciplinary tumor boards represents a challenge worldwide with regards to protection of agendas, decision binding and clinical protocols [23, 24]. This challenge is notably pronounced in Brazil, where the majority of cancer care is delivered through a frequently under-resourced public healthcare system, external to academic institutions. Here, the endeavor to optimize cancer care becomes markedly more daunting.

Nevertheless, prescribing ADT/ARPI requires not only knowledge about how patients tolerate the treatment but also how to handle follow-up care and side effects. Additionally, with the fast pace of advancements in prostate cancer treatment and how therapies are sequenced, doctors need to continually update their knowledge to stay current. In our survey, only 15.3% of the responders have had training to prescribe ARPi during urology residency, 22.3% of them prescribe ARPi in daily-practice and, among those who don’t prescribe it, 75.6% are interested in starting to do so. This demonstrates an increased interested by urologists in incorporating novel treatment agents into their daily practice and, perhaps, the recognition that the urologist must play a major role in the advanced PC patient management. In addition, it addresses an important issue related to the negative psychological impact of the referral in a critical time of the disease, as pointed out previously by Shore et al [15].

Previous studies demonstrated that treatment choice depends on the type of the physician [25], which was demonstrated in our results, since 97.85% of responders, all urologists, would treat a high-risk localized PC patient with surgery, instead of RT and ADT. However, the follow-up of patients who underwent RT, with or without ADT, is usually done by urologists, alone (26.67%) or together with the radiation oncologist (61.29%). When asked about follow-up in BCR, even without evidence of metastatic disease, only 33.76% of the urologists keep making therapeutic decisions alone and 56.99% work together with CO.

Online surveys are gaining increasing popularity. While providing valuable insights, our study is subject to several limitations that warrant consideration. Firstly, the reliance on self-reported data introduces the potential for response bias, as participants might have inaccurately recalled or selectively reported their practices and experiences. Furthermore, the sample, though substantial, may not fully represent the diversity of urological practice across different regions and settings, potentially affecting the generalizability of our findings. The exclusive distribution of the survey via SurveyMonkey, may have restricted participation. Alternative methods such as WhatsApp, telephone interviews or paper surveys were not implemented due to logistical constraints in a continental country like Brazil. Nevertheless, the response rate was 10.1%, in the lower tier of what can be expected in voluntary e-mail-based surveys, both globally [26-28].

The guidelines of urology societies, including the European Association of Urology (EAU) and the American Urological Association (AUA), delineate the standard of care within the context of APC, offering educational resources to assist urologists throughout every phase of the disease. Furthermore, on a national level, the SBU has embraced modern methods of continuous education, such as webinars and podcasts, to ensure that practitioners remain abreast of the latest developments and best practices in APC management. These innovative learning platforms facilitate the dissemination of cutting-edge research and clinical insights, significantly enriching the knowledge base of urologists in this rapidly evolving field. [29, 30]. This is an important part of the process of empowering the urologist as the healthcare provider during all stages of PC natural history. Besides, provision of care by a single physician can minimize the psychological and financial burden of multiple visits and treatment delays that may occur in a nonintegrated care system, which unfortunately, corresponds to most of the health system in Brazil.

Advanced PC management presents innumerous challenges. Many urologists are discouraged to or prefer not provide care to patients in this scenario. However, since ADT and ARPI indications are becoming more frequent in earlier stages of the disease, it is of utmost importance that urologists regain confidence to prescribe prostate cancer medical treatment and continue to follow patients even when the cancer progresses.

PC – Prostate cancer

INCA – Brazilian National Cancer Institute

ADT - androgen deprivation therapy

RT - radiation therapy

LHRHa - luteinizing hormone-releasing hormone agonists

ARPi - androgen receptor pathway inhibitor

CO - clinical oncologist

SBU - Brazilian Society of Urology

M0 - non-metastatic

M1 – metastatic

BCR - biochemical recurrence

CRPC – castration-resistant prostate cancer

mCRPC - metastatic castration-resistant prostate cancer

mCSPC - metastatic castration-sensitive prostate cancer

nmCRPC - non-metastatic castration-resistant prostate cancer

nmCSPC - non-metastatic castration-sensitive prostate cancer

EAU - European Association of Urology

AUA - American Urological Association

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Tables 1 to 3 are available in the Supplementary Files section

No competing interests reported.

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Advanced prostate cancer management by urologist: a real-life national survey in Brazil

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Supplementary Files

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