A phase IIb randomized placebo-controlled trial testing the effect of MAG-EPA long-chain omega-3 fatty acid dietary supplement on prostate cancer proliferation.

BACKGROUND: High prostate eicosapentaenoic fatty acid (EPA) levels were associated with a significant reduction of upgrading to grade group (GG) ≥ 2 prostate cancer in men under active surveillance. We aimed to evaluate the effect of MAG-EPA long-chain omega-3 fatty acid dietary supplement on prostate cancer proliferation. METHODS: A phase II double-blind randomized placebo-controlled trial was conducted in 130 men diagnosed with GG ≥ 2 prostate cancer and undergoing radical prostatectomy between 2015-2017 (Clinicaltrials.gov: NCT02333435). Participants were randomized to receive 3 g daily of either MAG-EPA (n = 65) or placebo (n = 65) for 7 weeks (range 4-10) prior to radical prostatectomy. The primary outcome was the cancer proliferation index quantified by automated image analysis of tumor nuclear Ki-67 expression using standardized prostatectomy tissue microarrays. Additional planned outcomes at surgery are reported including plasma levels of 27 inflammatory cytokines and fatty acid profiles in circulating red blood cells membranes and prostate tissue. RESULTS: Cancer proliferation index measured by Ki-67 expression was not statistically different between the intervention (3.10%) and placebo (2.85%) groups (p = 0.64). In the per protocol analyses, the adjusted estimated effect of MAG-EPA was greater but remained non-significant. Secondary outcome was the changes in plasma levels of 27 cytokines, of which only IL-7 was higher in MAG-EPA group compared to placebo (p = 0.026). Men randomized to MAG-EPA prior to surgery had four-fold higher EPA levels in prostate tissue compared to those on placebo. CONCLUSIONS: This MAG-EPA intervention did not affect the primary outcome of prostate cancer proliferation according to nuclear Ki-67 expression. More studies are needed to decipher the effects of long-chain omega-3 fatty acid dietary supplementation in men with prostate cancer.

It is thought that our diet can impact our risk of cancer and affect outcomes in patients with cancer. Omega-3 fatty acids, mostly found in fatty fish, might be beneficial by protecting against prostate cancer and its adverse outcomes. We conducted a clinical trial to test the effects of an omega-3 dietary supplement (MAG-EPA) in men with prostate cancer. We randomly allocated 130 men to receive either MAG-EPA or a placebo for 7 weeks before their prostate cancer surgery. We measured a marker of how much tumor cells were proliferating (or growing in number) at the point of surgery, which might indicate how aggressive their disease was. However, the supplement did not affect tumor cell proliferation. The supplement was therefore not beneficial in this group of patients and further studies  are needed to test and confirm the effects of MAG-EPA on prostate cancer cells.

Salvage therapy for BCG failure with intravesical sequential gemcitabine and docetaxel in patients with recurrent NMIBC.

INTRODUCTION: Bacillus Calmette-Guérin (BCG) failure occurs in approximately 40% of patients with non-muscle-invasive bladder cancer (NMIBC) within two years. We describe our institutional experience with sequential intravesical gemcitabine and docetaxel (gem/doce) as salvage therapy post-BCG failure in patients who were not candidates for or declined radical cystectomy (RC). METHODS: We retrospectively reviewed NMIBC patients with BCG failure who received gem/doce from April 2019 through October 2022 at the CHU de Québec-Université Laval. Patients received at least five weekly intravesical instillations according to published protocols. Patients who responded to gem/doce had maintenance instillations monthly for up to two years. Primary outcome was progression-free survival (PFS). Secondary outcomes included recurrence-free survival (RFS), cystectomy-free survival (CFS), cancer-specific survival (CSS), overall survival (OS), and treatment adverse events. Survival probabilities were estimated using the Kaplan-Meier method from the first gem/doce instillation. RESULTS: Thirty-five patients with a median age of 78 years old were included in the study. The median followup time was 21 months (interquartile range 10-29). More than 25% of patients received two or more prior BCG induction treatments. Overall and MIBC PFS estimates at one year were 85% and 88%, and at two years, 60% and 70%, respectively. Adverse events occurred in 37% of the patients, but only two patients didn't complete the treatment due to intolerance. Three patients underwent RC due to cancer progression. OS was 94% at two years. CONCLUSIONS: With 60% of PFS at two years, gem/doce appears to be a safe and well-tolerated option for BCG failure patients. Further studies are needed to justify widespread use.

Effects of omega-3 supplementation on psychological symptoms in men with prostate cancer: Secondary analysis of a double-blind placebo-controlled randomized trial.

BACKGROUND: In the general population, a higher omega-3 polyunsaturated fatty acids intake is associated with lower levels of several psychological symptoms, especially depression. However, the existing evidence in cancer is equivocal. METHODS: This phase IIB double-blind, placebo-controlled trial was aimed at comparing the effects of eicosapentaenoic acid monoacylglyceride (MAG-EPA) supplementation and high oleic acid sunflower oil (HOSO; placebo) on depression levels (primary outcome) and other symptoms (anxiety, fear of cancer recurrence, fatigue, insomnia, perceived cognitive impairments; secondary outcomes). Participants, recruited in a prostate cancer clinic, were randomized to MAG-EPA (3.75 g daily; n = 65) or HOSO (3.75 g daily; n = 65) for 1 year post-radical prostatectomy (RP), starting 4-10 weeks before surgery. Patients completed self-report scales at baseline (before RP) and 3, 6, 9, and 12 months after: Hospital Anxiety and Depression Scale (HADS), Fear of Cancer Recurrence Inventory (FCRI), Insomnia Severity Index (ISI), Fatigue Symptom Inventory (FSI), and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). RESULTS: Analyses showed significant reductions in HADS-depression, HADS-anxiety, FCRI, ISI, FSI-number of days, and FACT-Cog-impact scores over time. A significant group-by-time interaction was obtained on FACT-Cog-Impact scores only; yet, the temporal change was significant in HOSO patients only. CONCLUSIONS: Several symptoms significantly decreased over time, mainly within the first months of the study. However, MAG-EPA did not produce greater reductions than HOSO. Omega-3 supplementation does not seem to improve psychological symptoms of men treated with RP.

Effects of Concentrated Long-Chain Omega-3 Polyunsaturated Fatty Acid Supplementation on Quality of Life after Radical Prostatectomy: A Phase II Randomized Placebo-Controlled Trial (RCT-EPA).

Prostate cancer (PCa) and associated treatments incur symptoms that may impact patients' quality of life. Studies have shown beneficial relationships between diet, especially omega-3 fatty acids, and these symptoms. Unfortunately, only few data describing the relationship between long-chain omega-3 fatty acids (LCn3) and PCa-related symptoms in patients are available. The purpose of this study was to evaluate the effects of LCn3 supplementation on PCa-specific quality of life in 130 men treated by radical prostatectomy. Men were randomized to receive a daily dose of either 3.75 g of fish oil or a placebo starting 7 weeks before surgery and for up to one-year post-surgery. Quality of life was assessed using the validated EPIC-26 and IPSS questionnaires at randomization, at surgery, and every 3 months following surgery. Between-group differences were assessed using linear mixed models. Intention-to-treat analyses showed no significant difference between the two groups. However, at 12-month follow-up, per-protocol analyses showed a significantly greater increase in the urinary irritation function score (better urinary function) (MD = 5.5, p = 0.03) for the LCn3 group compared to placebo. These results suggest that LCn3 supplementation may improve the urinary irritation function in men with PCa treated by radical prostatectomy and support to conduct of larger-scale studies.

Obesity and Complication Risk From Radical Cystectomy: Identifying a Body Mass Index Threshold.

PURPOSE: There are conflicting reports regarding radical cystectomy complication risk from obesity subcategories, and a BMI threshold below which complication risk is notably reduced is undefined. A BMI threshold may be helpful in prehabilitation to aid patient counseling and inform weight loss strategies to potentially mitigate obesity-associated complication risk. This study aims to identify such a threshold and further investigate the association between BMI subcategories and perioperative complications from radical cystectomy. MATERIALS AND METHODS: Data were extracted from the Canadian Bladder Cancer Information System, a prospective registry across 14 academic centers. Five hundred and eighty-nine patients were analyzed. Perioperative (≤90 days) complications were compared between BMI subcategories. Unconditional multivariable logistic regression and cubic spline analysis were performed to determine the association between BMI and complication risk and identify a BMI threshold. RESULTS: Perioperative complications were reported in 51 (30%), 97 (43%), and 85 (43%) normal, overweight, and obese patients (P = .02). BMI was independently associated with developing any complication (OR 1.04 95% CI 1.01, 1.07). Predicted complication risk began to rise consistently above a BMI threshold of 34 kg/m2. Both overweight (OR 2.00 95% CI 1.26-3.17) and obese (OR 1.98 95% CI 1.24-3.18) patients had increased risk of complications compared to normal BMI patients. CONCLUSIONS: Complication risk from radical cystectomy is independently associated with BMI. Both overweight and obese patients are at increased risk compared to normal BMI patients. A BMI threshold of 34 kg/m2 has been identified, which may inform prehabilitation treatment strategies.

Analysis of sex-based differences to Bacillus Calmette-Guérin for non-muscle invasive bladder cancer.

OBJECTIVE: To evaluate whether differences exist between men and women in response to intravesical BCG treatments. The incidence of urothelial carcinoma of the bladder is lower in women but they tend to present with more aggressive and advanced disease. Some prior studies also suggest there are sex-based differences in response to treatment for non-muscle invasive bladder tumors. METHODS: In this retrospective study, we reviewed all consecutive patients who received BCG at the CHU de Québec - Laval University from 2009-2019. Men and women were treated with intravesical BCG therapy following pathologic confirmation of urothelial carcinoma. Outcomes evaluated include recurrence, progression, and treatment tolerability. Recurrence was defined as a pathology confirmed cancer whereas progression was the new development of high-grade (recurrence) pathology or an increase of stage. Tolerability was defined according to the proportion of prescribed BCG received. All clinical details were obtained through review of the medical records, collaborated by pharmacy records for BCG administration. Competing-risk analysis was used to compare outcomes. RESULTS: Among 613 patients who received BCG at our institution between 2009-2019, 472 (77.0%) were men and 141 (23.0%) were women. The recurrence rate was not different between sexes, with a 5-year recurrence risk of 52% (95% CI: 36.93-65.4) among women compared to 57.5% (CI 95%: 51.9-62.6) among men. The overall non-progression rate at 1,3 and 5 years was 97.3% (95% CI: 95.6%-98.3%), 93.6% (95% CI: 91.2%-95.4%), and 91.7% (95% CI: 88.4%-94.1%), respectively. The completion of ≥5 induction BCG instillations and maintenance BCG use was similar in both genders. CONCLUSIONS: We report a contemporary NMIBC cohort treated with BCG and find no clear evidence for sex-based differences in response to BCG treatment in regard of progression, recurrence, and tolerability.

Perception and satisfaction of patients after telemedicine urology consultations: A matched analysis with physicians' perspective.

INTRODUCTION: During the first regional COVID-19 lockdown in March 2020, we conducted a study aimed at evaluating completeness of telemedicine consultation in urology. Of 1679 consultations, 67% were considered completely managed by phone. The aim of the present study was to assess patients' experience and satisfaction with telemedicine and to compare them with urologists' perceptions about quality and completeness of the telemedicine consultation. METHODS: We contacted a randomly selected sample of patients (n=356) from our previous study to enquire about their experience. We used a home patient experience questionnaire, inspired by the Patient Experiences Questionnaire for Out-of-Hours Care (PEQOHC) and the Consumer Assessment Health Profile Survey (CAHPS). RESULTS: Of 356 patients contacted, 315 agreed to complete the questionnaire. Urological consultations were for non-oncological (104), oncological (121), cancer suspicion (41), and pediatric (49) indications. Mean patient satisfaction score after telemedicine consultation was 8.8/10 (median 9/10) and 86.3% of patients rated the quality of the consultation as either excellent (54.6%) or very good (31.7%). Consultations regarding cancer suspicion had the lowest score (8.3/10). Overall, 46.7% of all patients would have preferred an in-person visit outside of the pandemic situation. Among patients whose consultations were rated suboptimal by urologists, almost a third more (31.2%) would have preferred an in-person visit (p=0.03). CONCLUSIONS: Despite high reported patient satisfaction rates with telemedicine, it is noteworthy that nearly half of the patients would have preferred an in-person visit. Post-pandemic, it will be important to incorporate telemedicine as an alternative, while retaining and offering in-person visits.

Opioid use after uro-oncologic surgeries in time of opioid crisis.

INTRODUCTION: Recent literature emphasizes how overprescription and lack of guidelines contribute to wide variation in opioid prescribing practices and opioid-related harms. We conducted a prospective, observational study to evaluate opioid prescriptions among uro-oncologic patients discharged following elective in-patient surgery. METHODS: Patients who underwent four surgeries were included: open retropubic radical prostatectomy, robot-assisted radical prostatectomy, laparoscopic radical nephrectomy, and laparoscopic partial nephrectomy. The primary outcome was the dose of opioids used after discharge (in oral morphine equivalents [MEq]). Secondary outcomes included: opioid requirements for 80% of the patients, management of unused opioids, opioid use three months postoperative, opioid prescription refills, and guidance about opioid disposal. RESULTS: Sixty patients were included for analysis. Patients used a mean of 30 MEq (95% confidence interval 17.8-42.2) at home and 80% of the patients used 50 MEq or less. A mean of 40.4 MEq per patient was overprescribed. Fifty percent of the patients kept the remaining opioids at home, with only 20.0% returning them to their pharmacy. After three months, 5.0% of the patients were using opioids at least occasionally. Three patients needed a new opioid prescription. Forty percent reported having received information regarding management of unused opioids. CONCLUSIONS: We found 60% of opioids prescribed were unused, with half of our patients keeping these unused tablets at home. Our results suggest appropriate opioid prescription amounts needed for urological cancer surgery, with 80% of the patients using 50 MEq or less of morphine equivalents.

Effects of omega-3 fatty acids supplementation on perioperative blood loss and complications after radical prostatectomy.

BACKGROUND AND AIMS: Many dietary supplements, including omega-3 fatty acids (ω3), are suspected to affect blood coagulation and platelet function. Despite no clinical evidence, discontinuation is recommended before radical prostatectomy. However, long-chain ω3 (LCω3) appear beneficial against prostate cancer progression. Here, we aim to determine the effect of LCω3 supplements on perioperative bleeding, hemoglobin, platelets, and postoperative complications after radical prostatectomy. METHODS: This is a planned exploratory analysis of 130 patients diagnosed with prostate cancer grade group 2 or greater enrolled in a randomized controlled trial (NCT02333435) testing the effects of LCω3, on prostate cancer biological and pathological outcomes at radical prostatectomy as main outcomes. The LCω3 intervention (MAG-EPA 3 g daily) or equivalent placebo was given 4-10 weeks prior to radical prostatectomy. An intention-to-treat analysis approach was used with bi-variate statistical testing of bleeding and complications outcomes. We also estimated the difference between groups using linear regression and non-parametric quantile regression models. All models were adjusted for confounding variables selected on clinical relevance. RESULTS: We found no clinically significant effect of LCω3 versus placebo on perioperative bleeding, laboratory tests or postoperative complications. In contrast, as expected, we found a significant increase in perioperative bleeding in open retropubic radical prostatectomy compared to robot-assisted radical prostatectomy (adjusted difference 115.8 mL, p = 0.04). CONCLUSIONS: Our results suggest that ω3 supplements can be safely taken before radical prostatectomy without increasing surgical bleeding risk. These findings are relevant since ω3 may beneficially affect prostate cancer evolution.

18F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) is accurate for high-grade prostate cancer bone staging when compared to bone scintigraphy.

INTRODUCTION: In this study, we compared 18F-fluorodeoxyglucose (18F-FDG)-positron emission tomography/computed tomography (PET/CT) and bone scintigraphy accuracies for the detection of bone metastases for primary staging in high-grade prostate cancer (PCa) patients to determine if 18F-FDG-PET/CT could be used alone as a staging modality. METHODS: Men with localized high-grade PCa (n=256, Gleason 8-10, International Society of Urological Pathology [ISUP] grades 4 or 5) were imaged with bone scintigraphy and 18F-FDG-PET/CT. We compared, on a per-patient basis, the accuracy of the two imaging modalities, taking inter-modality agreement as the standard of truth (SOT). RESULTS: 18F-FDG-PET/CT detected at least one bone metastasis in 33 patients compared to only 26 with bone scan. Of the seven false-negative bone scintigraphies, four (57.1%) were solitary metastases (monometastatic), three (42.9%) were oligometastatic (2-4 lesions), and none were plurimetastatic (>4 lesions). Compared to SOT, 18F-FDG-PET/CT showed higher sensitivity and accuracy than bone scintigraphy (100% vs. 78.8%, and 98.7% vs. 98.2%) for the detection of skeletal lesions. CONCLUSIONS: 18F-FDG-PET/CT appears similar or better than conventional bone scans to assess for bone metastases in patients newly diagnosed with high-grade PCa. Since intraprostatic FDG uptake is also a biomarker for failure of radical prostatectomy and that FDG-PET/CT has been shown to be accurate in detecting PCa lymph node metastasis, FDG-PET/CT has the potential to be used as the sole preoperative staging modality in high-grade PCa.

Switching Cancers: A Systematic Review Assessing the Role of Androgen Suppressive Therapy in Bladder Cancer.

CONTEXT: Bladder cancer demonstrates striking gender-based differences in incidence, with a role for androgens possibly implicated in the development and progression of the disease. Emerging preclinical and clinical evidence suggests that there may be a role for antiandrogen therapy in bladder cancer. OBJECTIVE: This systematic review assessed the current clinical evidence evaluating androgen suppressive therapy (AST) for the treatment or prevention of bladder cancer. EVIDENCE ACQUISITION: Following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, MEDLINE was searched for full-text articles detailing clinical outcomes or incidence of bladder cancer among patients who received AST, defined as gonadotropin-releasing hormone agonists or equivalent, androgen receptor antagonists, or 5-alpha reductase inhibitors. EVIDENCE SYNTHESIS: A total of 12 studies were included. Five studies focused on prostate cancer patients, with one study in men with lower urinary tract symptoms. Among these studies, a lower incidence of bladder cancer was observed in five, with adjusted risk reduction estimates ranging from 7% to 47%. Six studies evaluating 11 820 bladder cancer patients investigated clinical outcomes among men who received a form of AST. Three out of four studies evaluating recurrence-free survival found a benefit for AST, with adjusted hazard ratios for recurrence of non-muscle-invasive cancer ranging from 0.29 to 0.53. Limitations included large variability in data sources and methodologies, as well as no data on tolerability. CONCLUSIONS: Current evidence indicates that antiandrogen therapies exert a favorable influence on bladder tumors. Further prospective studies are needed to assess their therapeutic potential. PATIENT SUMMARY: Androgen suppressive therapy is commonly prescribed for the treatment of prostate-related problems. Prior research indicates that there may be a role for these treatments in patients with bladder cancer. In this review, we evaluate the current evidence that strongly suggests that these agents may be effective against bladder cancer.

A prospective, multisite study analyzing the percentage of urological cases that can be completely managed by telemedicine.

INTRODUCTION: The COVID-19 pandemic has accelerated the development of telemedicine due to confinement measures. However, the percentage of outpatient urological cases that could be managed completely by telemedicine outside of the COVID-19 pandemic remains to be determined. We conducted a prospective, multisite study involving all urologists working in the region of Quebec City. METHODS: During the first four weeks of the regional confinement, 18 pediatric and adult urologists were asked to determine, after each telemedicine appointment, if it translated into a complete (CCM), incomplete (ICM), or suboptimal case management (SCM, adequate only in the context of the pandemic). RESULTS: A total of 1679 appointments representing all urological areas were registered. Overall, 67.6% (95% confidence interval [CI] 65.3; 69.8), 27.1% (25.0; 29.3), and 4.3% (3.5; 5.4) were reported as CCM, SCM, and ICM, respectively. The CCM ratio varied according to the reason for consultation, with cancer suspicion (52.9% [42.9; 62.8]) and pediatric reasons (38.0% [30.0; 46.6]) showing the lowest CCM percentages. CCM percentages also varied significantly based on the setting where it was performed, ranging from 61.1% (private clinic) to 86.8% (endourology and general hospital). CONCLUSIONS: We show that two-thirds of all urological outpatient cases could be completely managed by telemedicine outside of the pandemic. After the pandemic, it will be important to incorporate telemedicine as an alternative for a patient's first or followup visit, especially those with geographical, pathological, and socioeconomic considerations.

Receipt of 5-Alpha Reductase Inhibitors Before Radical Cystectomy: Do They Render High-Grade Bladder Tumors Less Aggressive?

PURPOSE: To assess whether receipt of 5-alpha reductase inhibitors (5-ARIs) influences the findings on surgical pathology at the time of radical cystectomy (RC) and subsequent clinical outcomes. 5-ARIs may slow the progression of non-muscle-invasive bladder cancer. PATIENTS AND METHODS: We retrospectively reviewed all patients who underwent RC at our institution between 2009 and 2017. Men were included who had urothelial cancer in the RC specimen. Patients with nonurothelial pathology or who had no cancer in the specimen were excluded. Odds ratios for pathologic features and hazard ratios for survival were adjusted for baseline patient characteristics and disease stage. RESULTS: Our study cohort included 338 men; 48 patients (14%) were receiving dutasteride or finasteride at time of RC, 58 (17%) metformin, and 195 (58%) statins. Among patients receiving 5-ARIs, there was a lower proportion of positive margins (P = .08) and lymphovascular invasion (P = .05). This was statistically significant when patients with urothelial carcinoma variants were excluded. Multivariable logistic regression analysis demonstrated that 5-ARI receipt was associated with a lower odds ratio (OR) for the presence of lymphovascular invasion (OR = 0.49; 95% confidence interval, 0.24-1.00; P = .049) and positive surgical margins (OR = 0.30; 95% confidence interval, 0.09-1.07; P = .063). Further, 5-ARI receipt was associated with better overall survival, with an adjusted hazard ratio of 0.40 (95% confidence interval, 0.19-0.83; P = .015). No similar tendencies were observed with metformin or statins. CONCLUSION: 5-ARIs may exert a protective biologic effect on the invasive properties of high-grade urothelial carcinoma. Further research is needed to understand the therapeutic implications.

Use and duration of antibiotic prophylaxis and the rate of urinary tract infection after radical cystectomy for bladder cancer: Results of a multicentric series.

OBJECTIVES: To assess the rate of urinary tract infection (UTI), the characteristics of the bacterial aetiological agents involved, the type and duration of antibiotics used, and the clinical risk factors of UTI in a multi-institutional cohort of patients who had undergone radical cystectomy (RC). PATIENTS AND METHODS: The pre- and postoperative characteristics of patients who had undergone open RC at 1 of 3 institutions between 2009 and 2015 were analyzed by means of the patient charts. Patients were classified according to the presence or absence of UTI. Analysis of the severity of UTI was based on the EAU/EAU Section of Infections in Urology (ESIU) classification system. The bacterial aetiological agents and their antibiotic susceptibility were also assessed. Factors predicting postoperative UTI were identified using univariable and multivariable logistic regression analysis. RESULTS: Of 217 patients, 42 (19.4%) had developed postoperative UTI, of whom 50% had urosepsis or uroseptic shock. Multivariable analysis showed continent urinary derivation as the only significant predictor of UTI with an odds ratio of 5.03 (95% confidence interval 2.12-11.9, P < 0.001). The duration of perioperative antibiotic prophylaxis was not associated with an increased risk of UTI. Enterococcus was the most commonly isolated bacteria (25.7%), but this species is not covered by the recommended antibiotic prophylaxis. CONCLUSION: Patients with continent urinary diversion after RC have a significantly higher risk of developing UTI. Prolonged perioperative administration of antibiotics does not seem to reduce the risk of UTI. Enterococcus as the most commonly isolated bacteria is not covered by most recommended antibiotic prophylaxis regimens. Therefore different antibiotic regimens should be considered for high-risk patients.

Prognostic value of urinary prostate cancer antigen 3 (PCA3) during active surveillance of patients with low-risk prostate cancer receiving 5α-reductase inhibitors.

OBJECTIVES: To determine the clinical performance of the urinary prostate cancer antigen 3 (PCA3) test to predict the risk of Gleason grade re-classification amongst men receiving a 5α-reductase inhibitor (5ARI) during active surveillance (AS) for prostate cancer. PATIENTS AND METHODS: Patients with low-risk prostate cancer were enrolled in a prospective Phase II study of AS complemented with prescription of a 5ARI. A repeat biopsy was taken within the first year and annually according to physician and patient preference. In all, 90 patients had urine collected after digital rectal examination of the prostate before the first repeat biopsy. The PCA3 test was performed in a blinded manner at a central laboratory. RESULTS: Using a PCA3-test score threshold of 35, there was a significant difference (P < 0.001) in the risk of being diagnosed with Gleason ≥7 cancer during a median of 7 years of follow-up. Adjusted Cox regression and Kaplan-Meier analyses also showed a significantly higher risk of upgrading to Gleason ≥7 during follow-up for those with a higher PCA3-test score. CONCLUSION: The urinary PCA3 test predicted Gleason grade re-classification amongst patients receiving a 5ARI during AS for low-risk prostate cancer.

Prostate cancer changes in clinical presentation and treatments in two decades: an Italian population-based study.

INTRODUCTION: The incidence of prostate cancer is on the rise in many industrialised countries, including Italy, most likely because of the spread of PSA testing. In Italy, prostate cancer mortality has been dropping since 2000, but it is difficult to understand whether PSA testing is the main reason, considering the role of treatment in prognosis. The objectives of this study were: (1) to describe Italian trends of prostate cancer risk categories and corresponding changes in treatment patterns and (2) to interpret changes in survival over time. METHODS: We made a retrospective observational study using population-based cancer registries. We examined two periods, 1996-1999 and 2005-2007, analysing the distribution of patients among risk groups and treatment changes in those intervals. We estimated 7- and 15-year relative survival with the cohort approach, Ederer II method. We analysed 4635 cases. RESULTS: There was downward risk migration from the first to the second period. In patients younger than 75 years, there was an increase in radical prostatectomy but not radiotherapy; patients older than 75 years rarely had treatment with radical intent. We noted an improvement of prostate cancer survival in the high-risk group. CONCLUSION: These findings raise several questions: the possible overtreatment of low-risk patients undergoing radical treatment; the utility of more aggressive treatment for elderly patients with high-risk disease; and the importance of a multidisciplinary clinical approach to ensure multiple and alternative treatment options. The increase in survival, with the decrease in mortality, suggests an effect of radical treatments on prognosis.

Clinical outcomes in octogenarians treated with docetaxel as first-line chemotherapy for castration-resistant prostate cancer.

AIM: To assess clinical outcomes in octogenarians treated with docetaxel (DOC) for metastatic castration-resistant prostate cancer. PATIENTS & METHODS: The multicenter retrospective study was based on a review of the pre- and post-DOC clinical history, DOC treatment and outcomes. RESULTS: We reviewed the records of 123 patients (median age: 82 years) who received DOC every 3 weeks or weekly, without significant grade 3-4 toxicities. Median progression-free survival was 7 months; median overall survival from the start of DOC was 20 months, but post-progression treatments significantly prolonged overall survival. CONCLUSION: The findings of this study suggest that toxicity is acceptable, survival is independent of patient's age and survival can be significantly prolonged by the use of new agents.