A European, prospective, observational study of enzalutamide in patients with metastatic castration-resistant prostate cancer: PREMISE.

In randomized clinical trials, the androgen-receptor inhibitor enzalutamide has demonstrated efficacy and safety in metastatic castration-resistant prostate cancer (mCRPC). This study captured efficacy, safety and patient-reported outcomes (PROs) of enzalutamide in mCRPC patients in a real-world European setting. PREMISE (NCT0249574) was a European, long-term, prospective, observational study in mCRPC patients prescribed enzalutamide as part of standard clinical practice. Patients were categorized based on prior docetaxel and/or abiraterone use. The primary endpoint was time to treatment failure (TTF), defined as time from enzalutamide initiation to permanent treatment discontinuation for any reason. Secondary endpoints included prostate-specific antigen (PSA) response, time to PSA progression, time to disease progression and safety. PROs included EuroQol 5-Dimension, 5-Level questionnaire, Functional Assessment of Cancer Therapy-Prostate and Brief Pain Inventory-Short Form. Overall, 1732 men were enrolled. Median TTF with enzalutamide was 12.9 months in the chemotherapy- and abiraterone-naïve cohort (Cohort 1) and 8.4 months in the postchemotherapy and abiraterone-naïve cohort (Cohort 2). Clinical outcomes based on secondary endpoints also varied between cohorts. Cohorts 1 and 2 showed small improvements in health-related quality of life and pain status. The proportions of patients reporting treatment-emergent adverse events (TEAEs) were 51.0% and 62.2% in Cohorts 1 and 2, respectively; enzalutamide-related TEAEs were similar in both cohorts. The most frequent TEAE across cohorts was fatigue. These data from unselected mCRPC patients in European, real-world, clinical-practice settings confirmed the benefits of enzalutamide previously shown in clinical trial outcomes, with safety results consistent with enzalutamide's known safety profile.

[Evaluation of radiofrequency (TUNA) in the outpatient treatment of benign prostatic hyperplasia]. / Evaluation de la radiofréquence (TUNA) dans le traitement de l'hypertrophie bénigne de prostate en chirurgie ambulatoire.

OBJECTIVE: Evaluating the effectiveness and feasibility of transurethral needle ablation (TUNA) for young patients with symptomatic benign hyperplasia (BPH) in outpatient care. MATERIAL AND METHODS: From 2004 to 2005, 9 patients (mean age: 59.7 years) were treated with the TUNA device. The urinary function using the IPSS (International Prostate Symptom Score), the quality of life score (QOL-UR), the uroflowmetry, and the post-void residue, and the sexual function using the International Index of Erectile Function score (IIEF-5) were assessed. RESULTS: Prior to thermotherapy, the mean IIEF-5 was 20.2. The mean preoperative IPSS and QOL-UR scores were respectively 25.2 and 5,6. Regarding uroflowmetry, the mean pre-treatment maximal urinary flow was 6 ml/s and the mean post-void residue was 167.1 mL. Patients' follow-up was at intervals of 3 months. With a mean follow-up of 9.5 months, 8 patients have achieved a better urinary status with a mean IPSS and QOL-UR score of 9.5 and 1.6 respectively (p<0.05). The mean maximal flow rate was improved (14 ml/s, p< 0,05). The post-void residue decreased but had no statistical significance. The IIEF-5 score remained unchanged. Only 4 complications including 3 urinary retentions and 1 prostatitis were revealed for 3 patients. No failure with radiofrequency thermal therapy was observed. CONCLUSION: TUNA as a mini-invasive outpatient treatment for symptomatic BPH proved reliable and reproducible for young patients with preserved sexual function.

Focal High Intensity Focused Ultrasound of Unilateral Localized Prostate Cancer: A Prospective Multicentric Hemiablation Study of 111 Patients.

BACKGROUND: Up to a third of patients with localized prostate cancer have unilateral disease that may be suitable for partial treatment with hemiablation. OBJECTIVE: To evaluate the ability of high intensity focused ultrasound (HIFU) to achieve local control of the tumor in patients with unilateral localized prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: The French Urological Association initiated a prospective IDEAL multi-institutional study (2009-2015), to evaluate HIFU-hemiablation as a primary treatment. INTERVENTION: Multiparametric magnetic resonance imaging and biopsy were used for unilateral cancer diagnosis and control, and HIFU-hemiablation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary: absence of clinically significant cancer (CSC) on control biopsy at 1 yr (CSC: Gleason score ≥ 7 or cancer core length>3mm regardless of grade or > 2 positive cores). Secondary: presence of any cancer on biopsy, biochemical response, radical treatment free survival, adverse events, continence (no pad), erectile function (International Index of Erectile Function-5 ≥ 16), and quality of life (European Organization for Research and Treatment of Cancer QLQ-C28) questionnaires. RESULTS AND LIMITATIONS: One hundred and eleven patients were treated (mean age: 64.8 yr [standard deviation 6.2]; mean prostate-specific antigen: 6.2 ng/ml [standard deviation 2.6]; 68% low risk, 32% intermediate risk). Of the 101 patients with control biopsy, 96 (95%) and 94 (93%) had no CSC in the treated and contralateral lobes, respectively. Mean prostate-specific antigen at 2 yr was 2.3 ng/ml (standard deviation 1.7). The radical treatment-free survival rate at 2 years was 89% (radical treatments: six radical prostatectomies, three radiotherapies, and two HIFU). Adverse events were Grade 3 in 13%. At 12 mo continence and erectile functions were preserved in 97% and 78%. No significant decrease in quality of life score was observed at 12 mo. One limitation is the number of low-risk patients included in this study. CONCLUSIONS: At 1 yr, HIFU-hemiablation was efficient with 95% absence of clinically significant cancer associated with low morbidity and preservation of quality of life. Radical treatment-free survival rate was 89% at 2 yr. PATIENT SUMMARY: This report shows that high intensity focused ultrasound half-gland treatment of unilateral prostate cancer provides promising results with high cancer control and low morbidity.

[Comparison of two methods of local anaesthesia prior to transrectal ultrasound-guided prostate biopsies]. / Comparaison de deux méthodes d'anesthésie locale avant biopsies transrectales echo-guidées de prostate.

OBJECTIVE: To compare the analgesic efficacy of rectal administration of Lidocaïne gel with Lidocaïne periprostatic infiltration prior to transrectal ultrasound-guided prostate biopsies. MATERIAL AND METHODS: Between July 2002 and July 2003, candidates to prostate biopsies were randomised into two groups. In group 1, 15 ml 2% Lidocaïne gel was administered intra-rectally 10 minutes prior to biopsies and patients included in group 2 received 10 ml of 1% Lidocaïne in two périprostatique equivalent injections, 4 minutes prior to prostate biopsies. Pain was assessed with a Visual Analog Scale, during anaesthesia (VAS 1), during the biopsies procedure (VAS 2) and 30 minutes after them (VAS 3). RESULTS: 308 patients were included in this trial with 156 patients in group 1 and 152 in group 2. Group 1 experienced statistically less pain for VAS 1 (0.1 versus 1.4, p < 0.0001) and VAS 3 (0.8 versus 1.4, p < 0.001) but no significative difference could be demonstrated for VAS 2 (1.8 versus 2.0). No major complication was noted. CONCLUSION: Rectal administration of Lidocaïne gel and infiltration of Lidocaïne lead to a comparable level of anaesthesia during prostatic biopsies procedure. However, the Lidocaïne gel, being both safe and simple, tends to maintain a better comfort of the patient 30 minutes after the end of the biopsies.

GSTM1 and GSTT1 polymorphisms and the risk of prostate cancer in a Caribbean population of African descent.

OBJECTIVES: To investigate whether the glutathione S-transferase polymorphisms GSTM1 and/or GSTT1 contribute to prostate cancer risk in a Caribbean population of African descent in Guadeloupe. METHODS: We performed a hospital-based case-control study with 134 prostate cancer patients and 134 cancer-free, age-matched control subjects. Epidemiologic data were collected using a standard questionnaire. Logistic regression was used to estimate odds ratios (ORs) and compute confidence intervals (CIs). Genotypes were determined by multiplex polymerase chain reaction. RESULTS: The frequency of the GSTM1-positive genotype was 81% in patients and 73% in control subjects, with an adjusted OR of 1.4 (95% CI 0.7 to 2.5). The frequency of the GSTT1-positive genotype was 78% in patients and 63% in control subjects, with an adjusted OR of 2.6 (95% CI 1.4 to 4.9). CONCLUSIONS: A functional GSTT1 polymorphism may be associated with prostate cancer susceptibility in a Caribbean population of African descent.

Prostate cancer incidence in guadeloupe, a French Caribbean archipelago.

OBJECTIVE: To determine the incidence rate of prostate cancer in Guadeloupe, a French Caribbean archipelago with 420,000 inhabitants, 90% of whom are of African descent. METHODS: All new cases of prostate cancer diagnosed from 1995 to 2003 were identified from the records of all public and private pathology laboratories. We studied changes in incidence rate over time by calculating incidence rates and cumulative risk, standardized to the World Standard Population, and comparing them with the rates in other countries. RESULTS: 2531 new cases of prostate cancer, all pathologically confirmed, were recorded from 1995 to 2003. For 2003, there were 427 new cases, corresponding to a world age-standardized incidence rate, and cumulative risk up to 74 years of age of 168.7 per 100,000 and 20%, respectively. CONCLUSIONS: Guadeloupe has one of the highest incidences of prostate cancer in the world. The geographic and environmental characteristics of Guadeloupe make this area unique and should shed new light on the role of genetic and environmental factors in prostate cancer.

Local anesthesia before transrectal ultrasound guided prostate biopsy: comparison of 2 methods in a prospective, randomized clinical trial.

PURPOSE: We compared the analgesic efficacy of the rectal administration of lidocaine gel and lidocaine periprostatic infiltration prior to transrectal ultrasound guided prostatic biopsies. MATERIALS AND METHODS: A total of 328 consecutive men undergoing biopsy were entered into this study. The 166 patients randomized to group 1 received 15 cc 2% lidocaine gel administered intrarectally 10 minutes before prostate biopsy and the 162 in group 2 received 10 cc 1% lidocaine under ultrasound guidance as 2 periprostatic injections of 5 cc 5 minutes prior to biopsy. A self-administered visual analogue scale (VAS) was used to assess the pain score during anesthesia (VAS 1), during biopsy (VAS 2) and 30 minutes later (VAS 3). RESULTS: The patients in group 1 experienced statistically less pain than those in group 2 for mean VAS 1 (0.1 vs 1.4, p <0.0001) and mean VAS 3 (0.8 vs 1.4, p <0.001) but no statistically significant difference was noted for mean VAS 2 (2.0 vs 2.6, p = 0.04). No major morbidity was reported with either anesthesia. CONCLUSIONS: We are quite convinced of the necessity of local anesthesia to decrease pain during transrectal prostate ultrasound guided biopsy. Rectal administration of lidocaine gel is safe, simple and effective even when no difference regarding pain is noted vs lidocaine periprostatic infiltration during the biopsy procedure.