Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial.

PURPOSE: Transrectal prostate biopsy has come under scrutiny due to potential for postbiopsy infections and transperineal prostate biopsy is being offered as the safer alternative. However, there is a lack of randomized comparative studies. Our goal was to directly evaluate infectious and noninfectious complications following the 2 biopsy procedures. MATERIALS AND METHODS: We conducted a prospective, pragmatic, randomized clinical study in men undergoing prostate biopsy. The participants underwent either transrectal or transperineal prostate biopsy in the office under local anesthesia. The primary outcome was a 30-day composite infectious complication rate, comprising of 1 or more components including fever, genitourinary infection, antibiotic prescriptions, office or emergency visits, hospitalization, or sepsis. Secondary outcomes included 30-day composite noninfectious complications (urinary or hemorrhagic). RESULTS: Of the 763 randomized participants, 718 underwent either transrectal (351) or transperineal (367) prostate biopsy. A composite infectious complication event occurred in 9 participants (2.6%) in the transrectal and 10 participants (2.7%) in the transperineal group (odds ratio, 1.06; 95% CI, 0.43 to 2.65; P = .99). None of the participants developed sepsis in either group. There were no between-group differences in any of the individual component infectious events. A composite noninfectious complication occurred in 6 (1.7%) and 8 (2.2%) participants in the transrectal and transperineal groups, respectively (odds ratio, 1.28; 95% CI, 0.44 to 3.73; P = .79). No participants required hospitalization or other interventions. CONCLUSIONS: Among men undergoing transperineal or transrectal prostate biopsy, we could not demonstrate any difference in the infectious or noninfectious complications. Both biopsy approaches remain clinically viable and safe.

Pelvic Organ Preservation in Non-muscle-invasive Bladder Cancer: Less Is More.

Radical cystectomy (RC) is a treatment option for high-risk non-muscle-invasive bladder cancer (NMIBC) but is associated with high morbidity and a negative impact on quality of life. Reproductive or pelvic organ-sparing cystectomy (ROSC) techniques have emerged as a potential strategy to mitigate some potential effects of standard RC. Here we discuss current knowledge regarding oncological, functional, and sexual function outcomes associated with ROSC and their applicability in NMIBC. These outcomes can be used to make informed clinical decisions regarding cystectomy technique in appropriately staged and selected patients with NMIBC. PATIENT SUMMARY: We reviewed results for bladder cancer control, urinary function, and sexual function after removal of the bladder with and without techniques to spare reproductive or pelvic organs. We found evidence of better sexual function outcomes with a sparing approach without compromise of cancer control. Further studies are needed to assess urinary function and pelvic floor-related outcomes.

Implementation and Assessment of No Opioid Prescription Strategy at Discharge After Major Urologic Cancer Surgery.

Importance: Postoperative opioid prescriptions are associated with delayed recovery, perioperative complications, opioid use disorder, and diversion of overprescribed opioids, which places the community at risk of opioid misuse or addiction. Objective: To assess a protocol for eliminating postdischarge opioid prescriptions after major urologic cancer surgery. Design, Setting, and Participants: This cohort study of the no opioid prescriptions at discharge after surgery (NOPIOIDS) protocol was conducted between May 2017 and June 2021 at a tertiary referral center. Patients undergoing open or minimally invasive radical cystectomy, radical or partial nephrectomy, and radical prostatectomy were sorted into the control group (usual opioids), the lead-in group (reduced opioids), and the NOPIOIDS group (no opioid prescriptions). Interventions: The NOPIOIDS group received a preadmission educational handout, postdischarge instructions for using nonopioid analgesics, and no routine opioid prescriptions. The lead-in group received a postdischarge instruction sheet and reduced opioid prescriptions at prescribers' discretion. The control group received opioid prescriptions at prescribers' discretion. Main Outcomes and Measures: Primary outcome measures included rate and dose of opioid prescriptions at discharge and for 30 days postdischarge. Additional outcome measures included patient-reported pain and satisfaction level, unplanned health care utilization, and postoperative complications. Results: Of 647 opioid-naive patients (mean [SD] age, 63.6 [10.0] years; 478 [73.9%] male; 586 [90.6%] White), the rate of opioid prescriptions at discharge for the control, the lead-in, and the NOPIOIDS groups was 80.9% (157 of 194), 57.9% (55 of 95), and 2.2% (8 of 358) (Kruskal-Wallis test of medians: P < .001), and the overall median (IQR) tablets prescribed was 14 (10-20), 4 (0-5.3), and 0 (0-0) per patient in the control, lead-in, and NOPIOIDS groups, respectively (Kruskal-Wallis test of medians: P < .001). In the NOPIOIDS group, median and mean opioid dose was 0 tablets for all procedure types, with the exception of kidney procedures (mean [SD], 0.5 [1.7] tablets). Patient-reported pain surveys were received from 358 patients (72.6%) in the NOPIOIDS group, demonstrating low pain scores (mean [SD], 2.5 [0.86]) and high satisfaction scores (mean [SD], 86.6 [3.8]). There was no increase in postoperative complications in the group with no opioid prescriptions. Conclusions and Relevance: This perioperative protocol, with emphasis on nonopioid alternatives and patient instructions, may be safe and effective in nearly eliminating the need for opioid prescriptions after major abdominopelvic cancer surgery without adversely affecting pain control, complications, or recovery.

Prevalence, Predictors, and Oncologic Outcomes of Pelvic Organ Involvement in Women Undergoing Radical Cystectomy.

CONTEXT.­: In women, radical cystectomy includes removal of the bladder, uterus, fallopian tubes, ovaries, and anterior vaginal wall, yet contiguous extension of urothelial carcinoma to all pelvic organs is rare and routine removal may be unnecessary. OBJECTIVE.­: To study pelvic organ involvement in women at radical cystectomy and investigate oncologic outcomes. DESIGN.­: Women with bladder cancer who underwent radical cystectomy at the Mayo Clinic and University of Toronto (1980-2018) were evaluated. Cancer-specific survival (CSS) was estimated with the Kaplan-Meier method; comparisons were made with the log-rank test. Associations with CSS were evaluated with Cox proportional hazard modeling. RESULTS.­: A total of 70 women with pT4a and 83 with pT3b cancer were studied. Organs involved were vagina (n = 41 of 70; 58.6%), uterus (n = 26 of 54; 48.1%), cervix (n = 15 of 54; 27.8%), fallopian tubes (n = 10 of 58; 17.2%), and ovaries (n = 7 of 58; 12.1%); 22 of 58 patients (37.9%) had >1 organ involved. Of 70 with pT4a cancer, 64 were available for survival analysis by 3 pelvic organ groups: vaginal only, vaginal and/or cervical/uterine, and vaginal and/or cervical/uterine and/or fallopian tubes/ovarian involvement. Three-year CSS for vaginal involvement only was 39%; it was 14% if cervical/uterine involvement, and <1% if fallopian tube/ovarian involvement was included (P = .02). Among 20 women with pT4aN0/Nx and vaginal involvement only, 3-year CSS for vaginal involvement was 50%, whereas among 48 women with pT3bN0/Nx cancer, 3-year CSS was 58%, P = .70. CONCLUSIONS.­: Isolated vaginal involvement should be separated from uterine and/or adnexal extension of urothelial carcinoma at pathologic staging. Direct ovarian extension is rare and routine removal may be unnecessary.

Radical cystectomy and women's sexual health - can we do better?

PURPOSE OF REVIEW: Female sexual function after radical cystectomy is a crucial, but historically overlooked component of bladder cancer survivorship. This review focuses on recent studies, which have investigated pelvic health and sexual function after radical cystectomy. We discuss modifiable factors, which may contribute to decreased sexual function after radical cystectomy and techniques, which may lead to improved outcomes. RECENT FINDINGS: Sexual function is important to women and there is a significant desire (and unmet need) for more perioperative counseling and discussion regarding sexual function changes and quality of life impacts. Sexual function may be altered due to a combination of hormonal changes from ovarian removal, anatomic changes from vaginal alteration, and sensation changes due to damage to the neurovascular bundle. Techniques to preserve these structures have been developed. SUMMARY: Sexual function is an important component of survivorship and increasing attention is being focused on this area. Long term studies with objective measures are needed for to compare various techniques and ensure oncologic safety. Ovarian preservation, anterior vaginal wall preservation, and vaginal estrogen replacement should be carefully considered for most patients.

Barriers to sexual recovery in women with urologic cancers.

Sexual health concerns are prevalent and distressing in oncology patients and survivors. While urologic cancers are more prevalent in men, women often have more advanced disease at initial diagnosis, require more advanced surgical resection, and experience higher postoperative complication rates, as well as morbidity and mortality. Women with urologic cancers undergo treatment that is highly likely to impact their sexual function and well-being, however, attention to sexual recovery in this patient population has been limited. Barriers to sexual recovery in women with urologic cancers are biopsychosocial in nature and include complications related to treatment procedures, cancer-related distress, sexual anxiety and avoidance, partner and relational dynamics, and sexual communication skills. Healthcare providers do not adequately address sexual difficulties for these patients and their partners. Sexual minority women and transgender patients with urologic cancer have unique psychosocial and sexual health needs though, due to a lack of research, these remain poorly understood. More research is needed to pinpoint the sexual health needs of this specific oncology population and to explore how various treatment options, such as pelvic organ-sparing cystectomy, can impact sexual health outcomes. Evidence-based and multidisciplinary oncologic and survivorship care, which includes licensed mental health providers, certified sex therapists, and other sexual health experts, is essential for assisting women in their sexual recovery following urologic cancer.

The association of salvage intravesical therapy following BCG with pathologic outcomes and survival after radical cystectomy for patients with high-grade non-muscle invasive bladder cancer: A multi-institution analysis.

INTRODUCTION: While numerous current clinical trials are testing novel salvage therapies (ST) for patients with recurrent nonmuscle invasive bladder cancer (NMIBC) after bacillus Calmette-Guérin (BCG), the natural history of this disease state has been poorly defined to date. Herein, we evaluated oncologic outcomes in patients previously treated with BCG and ST who subsequently underwent radical cystectomy (RC). METHODS: We identified 378 patients with high-grade NMIBC who received at least one complete induction course of BCG (n = 378) with (n = 62) or without (n = 316) additional ST and who then underwent RC between 2000 and 2018. Oncologic outcomes were compared using the Kaplan-Meier method and Cox proportional hazards models. Sensitivity analyses were conducted stratifying by presenting tumor stage, matched 1:3 for receipt vs. no receipt of ST. RESULTS: Patients receiving ST were more likely to initially present with CIS (26% vs. 17%) and less likely with T1 disease (34% vs. 50%, P = 0.06) compared to patients not treated with ST. Receipt of ST was not associated with increased risk of adverse pathology (≥pT2 or pN+) at RC (31% vs. 41%, P = 0.14). Likewise, 5-year cancer-specific survival did not significantly differ between groups on univariable Kaplan-Meier analysis (73% for ST and 74% for no ST, P = 0.7). Moreover, on multivariable analysis, receipt of ST was not significantly associated the risk of death from bladder cancer (HR 1.12; 95% CI 0.60-2.09, P = 0.7). Results were unchanged on sensitivity analysis. CONCLUSIONS: These data suggest that, in carefully selected patients, ST following BCG for high grade NMIBC does not compromise oncologic outcomes for patients who ultimately undergo RC.

Optimizing Women's Sexual Function and Sexual Experience After Radical Cystectomy.

Survivorship in bladder cancer has improved in terms of lower morbidity, mortality, and improved oncological outcomes. However, there is a dearth of research on women's quality of life, specifically, on the effect of radical cystectomy on women's sexual function and sexual experience. This narrative literature review focuses on the current state of knowledge about women's sexual function after cystectomy, identifies patient and provider-related factors that have contributed to the lack of research and sexual health support in clinical practice, and proposes a model for sexual rehabilitation as well as future areas for research.

Obesity is Associated with Longer Survival Independent of Sarcopenia and Myosteatosis in Metastatic and/or Castrate-Resistant Prostate Cancer.

PURPOSE: Obesity (body mass index 30 kg/m2 or greater) is associated with better overall survival in metastatic prostate cancer. Conversely, low muscle mass (sarcopenia) and low muscle radiodensity (myosteatosis) are associated with worse overall survival in many cancers. This study seeks to evaluate the relationship of sarcopenia, myosteatosis and obesity with overall survival in men with metastatic or castrate-resistant prostate cancer. MATERIALS AND METHODS: Retrospective analysis of men with metastatic or castrate-resistant prostate cancer and computerized tomography of abdomen/pelvis presenting to the Vanderbilt Comprehensive Prostate Cancer Clinic from 2012 to 2017 was performed. Demographic, pathological and survival data were described, with sarcopenia and myosteatosis determined from abdominal skeletal muscle area and skeletal muscle radiodensity, respectively. Kaplan-Meier curves and log-rank tests estimated the effect of body composition on survival. Multivariable Cox proportional hazard models were performed adjusting for age, Charlson comorbidity index, race and clinical stage. ANOVA was used to compare obese and nonobese men with and without sarcopenia or myosteatosis. RESULTS: Of 182 men accrued, 37.4% were obese, 53.3% sarcopenic and 59.3% myosteatotic. Over a median followup of 33.9 months, body mass index was associated with reduced mortality (HR 0.93, p=0.02), as was visceral adiposity (HR 0.99, p=0.003). Men with high body mass index without sarcopenia/myosteatosis lived significantly longer than men with high body mass index with sarcopenia/myosteatosis or normal body mass index men (F[3,91]=4.03, p=0.01). CONCLUSIONS: Both high body mass index and visceral adiposity in metastatic or castrate-resistant prostate cancer are associated with reduced mortality, independent of sarcopenia and myosteatosis. Therefore, routine clinical workup should include calculation of body mass index and measurement of waist circumference. Morphometric analysis of computerized tomography imaging can identify patients at risk for poor prognosis.

Grading Chromophobe Renal Cell Carcinoma: Evidence for a Four-tiered Classification Incorporating Coagulative Tumor Necrosis.

BACKGROUND: Although grading systems have been proposed for chromophobe renal cell carcinoma (ChRCC), including a three-tiered system by Paner et al (Paner GP, Amin MB, Alvarado-Cabrero I, et al. A novel tumor grading scheme for chromophobe renal cell carcinoma: prognostic utility and comparison with Fuhrman nuclear grade. Am J Surg Pathol 2010;34:1233-40), none have gained clinical acceptance, and the World Health Organization (WHO) currently recommends against grading ChRCC. OBJECTIVE: To validate a previously published grading scheme and propose a scheme that includes tumor necrosis. DESIGN, SETTING, AND PARTICIPANTS: A total of 266 patients who underwent nephrectomy for nonmetastatic ChRCC between 1970 and 2012 were reviewed for ChRCC grade according to the Paner system and coagulative tumor necrosis. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Associations with cancer-specific survival (CSS) were evaluated using Cox proportional hazard regression models and summarized with hazard ratios (HRs). RESULTS AND LIMITATIONS: Twenty-nine patients died from RCC; the median follow-up was 11.0 (interquartile range 7.9-15.9) yr. ChRCC grade according to the Paner system was significantly associated with CSS, including the difference in outcome between grade 1 and 2 tumors. Among patients with grade 2 tumors, the presence of tumor necrosis helped delineate patients with worse CSS. As such, the Paner system was expanded to four tiers separating grade 2 into those with and without tumor necrosis. HRs for associations of the proposed grade 2, 3, and 4 tumors with CSS were 4.63 (p=0.007), 17.8 (p<0.001), and 20.9 (p<0.001), respectively. The study is limited by the lack of multivariable analysis including additional pathologic features. CONCLUSIONS: The expansion of a previously reported ChRCC grading system from three to four tiers by the inclusion of tumor necrosis helps further delineate patient outcome and can, therefore, enhance patient counseling following surgery. It also aligns the number of ChRCC grades with the WHO/International Society of Urologic Pathology four-tiered grading systems for clear cell and papillary RCC. PATIENT SUMMARY: Chromophobe renal cell carcinoma is the third most common type of renal cancer, and unlike other renal cancers, there is no accepted prognostic grading system. In this study, we found that a grading system that included a pathologic feature of tumor necrosis could better define outcomes for patients with chromophobe renal cell carcinoma.

Long-term outcomes of incidental prostate cancer at radical cystectomy.

OBJECTIVE: We evaluated the natural history and long-term outcomes of incidentally detected prostate cancer (PCa) at radical cystectomy (RC) for bladder cancer (BCa). PATIENTS AND METHODS: We identified 1,640 male patients who underwent RC between 1992 and 2012. Patients were stratified as clinically insignificant and clinically significant PCa, based on Grade Group (GG) 1 and ≥2, respectively. Survival was assessed using the Kaplan-Meier method. RESULTS: There were 329 (20%) patients with incidentally detected PCa at RC: 245 (15%) GG1, 52 (3.2%) GG2, 20 (1.2%) GG3, 6 (0.4%) GG4, and 6 (0.4%) GG5. Median follow-up among survivors was 9.6 years (interquartile range 7.5-13.3), during which time 253 patients died, of whom 127 died of BCa and 1 died of PCa. Nine patients experienced biochemical recurrence (BCR), 4 underwent salvage PCa therapies, and 2 developed PCa metastases. Patients with clinically significant PCa were significantly more likely to experience BCR (6% vs. 1.6%; P = 0.04) and had shorter median time to BCR (1.8 vs. 10.4 years; P = 0.01) than those with clinically insignificant PCa. No patients with BCR had greater than pT2N0 BCa or positive BCa margins. Ten-year PCa-specific survival, BCa-specific survival, other cause-specific survival, and overall survival were 99%, 57%, 63%, and 35%, respectively. CONCLUSIONS: In a large RC series, we note a 20% rate of incidental PCa, the majority of which are clinically insignificant. On long-term follow-up, we determined that BCR and PCa mortality are extremely rare events among these patients. Pending validation, future guidelines may consider omission of PCa surveillance for some patients with incidental PCa at RC.

Decision analysis defining optimal management of clinical stage 1 high-risk nonseminomatous germ cell testicular cancer with lymphovascular invasion.

BACKGROUND: Risk of recurrent disease for men with clinical stage 1 high-risk nonseminomatous germ cell testicular cancer (CS1 NSGCT) with lymphovascular invasion (LVI) after orchiectomy is 50% and current treatment options (surveillance [S], retroperitoneal lymph node dissection [RPLND], or 1 cycle of BEP [BEP ×1]) are associated with a 99% disease specific survival, therefore practice patterns vary. We performed a decision analysis using updated data of long-term complications for men with CS1 NSGCT with LVI to quantify and assess relative treatment values. METHODS: Decision analysis included previously defined utilities (via standard gamble) for posttreatment states of living from 0 (death from disease) to 1 (alive in perfect health) and updated morbidity probabilities. We quantified the values of S, RPLND, and BEP ×1 via the rollback method. Sensitivity analyses including a range of orchiectomy cure rates and utility values were performed. RESULTS: Estimated probabilities favoring treatment with RPLND (0.97) or BEP ×1 (0.97) were equivalent and superior to surveillance (0.88). Sensitivity analysis of orchiectomy cure rates (50%-100%) failed to find a cure rate that favored S over BEP ×1 or RPLND. Varying utility values for cure after S from 0.92 (previously defined utility) to 1 (perfect health), failed to find a viable utility state favoring S over BEP ×1 or RPLND. An orchiectomy cure rate of ≥82% would be required for S to equal treatment of either type. CONCLUSIONS: We demonstrate that for surveillance to be superior to treatment with BEP ×1 or RPLND, the orchiectomy cure rate must be at least 82%, which is not expected in a patient population with high-risk CS1 NSGCT.

Role and Indications of Organ-Sparing "Radical" Cystectomy: The Importance of Careful Patient Selection and Counseling.

Organ-sparing cystectomy remains an operation for a highly selected patient population that can offer similar oncologic outcomes but improved sexual function in men and women. Occult prostate cancer in men may occur even with screening but the majority is of clinical insignificance. Paramount to patient selection are oncologic concerns, but preoperative sexual function, age, performance status, and postoperative expectations must also be evaluated during patient selection. Improved diagnostic and surveillance tools may facilitate and improve patient selection in the future.