Background: Fatigue is one of the most common adverse events of systemic therapy in patients with metastatic renal cell carcinoma (RCC). The aim of multicenter randomized phase 2 study was to determine the efficacy and safety of testosterone in patients with fatigue developed during targeted therapy.Patients and Methods: Male patients with metastatic clear-cell RCC, normal prostate-specific antigen level, low testosterone level, and no evidence of hypothyroidism receiving first-line sunitinib or pazopanib with fatigue were randomly assigned (1:1) to either testosterone undecanoate (1000 mg) and targeted therapy or targeted therapy alone. The primary endpoint was the mean change of fatigue from baseline to 28 days according to the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary endpoints were safety, Functional Assessment of Cancer Therapy-Kidney Symptom Index 19, testosterone serum concentrations, red blood cell count, and hemoglobin level.Results: Sixty patients were assigned to receive testosterone and targeted therapy (N = 30) or targeted therapy alone (N = 30). As of the data cutoff on December 30, 2019, median follow-up was 18.2 months. The study achieved its primary endpoint based on the significant differences at day 28 favoring testosterone over targeted therapy alone regarding the decreased level of fatigue (difference between groups, 22.5 points; 95% confidence interval, 18.4-26.6; P = 0.012). Significant changes in scores demonstrating the enhanced quality of life with testosterone compared with targeted therapy were also observed for Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 disease-related symptoms (P = 0.01). There were nonsignificant differences in red blood cell count and hemoglobin level between the 2 groups (all P > 0.05). Conclusion:Male patients with metastatic RCC and hypogonadism receiving testosterone had less fatigue and better symptom control during targeted therapy.

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574 Background: In multicenter randomized phase 2 study (FARETES) we showed that male patients with mRCC receiving targeted therapy had significantly less fatigue and better symptom control with testosterone undecanoate (T) (MASCC 2018, LBA004). Here we described exploratory endpoints in FARETES study. Methods: Sixty male patients with clear cell mRCC, normal PSA level, low testosterone level and no evidence of hypothyroidism receiving first-line sunitinib or pazopanib with fatigue were randomly assigned (1:1) to either T (Nebido, 1,000 mg) and targeted therapy or targeted therapy alone (control group). T was injected intramuscular deeply on Day 1 of a new treatment cycle. Exploratory endpoints included rate of adverse events (AE) of targeted therapy, duration of targeted therapy, objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). Results: As of the data cutoff on October 17, 2018, median (range) follow-up was 15.2 (9.9 -16.5) months. No unexpected toxicity of T was observed. Grade 3-4 targeted therapy-related AE occurred in 11 (37%) and 3 (10%) patients in the control group and T group, respectively. Discontinuation due to AE was observed in 3% (1/30) of patients in the T group and in 17% (5/30) of patients in the control group. ORR and PFS were significantly better in the T group (all P < 0.05, Table). Median OS was not reached in either group. Clinical trial information: NCT03379012. Conclusions: T therapy could decrease rate of serious AE of targeted therapy. Male mRCC patients receiving T had longer duration of targeted therapy, better PFS and ORR. Larger trials are needed to evaluate efficacy of T in this group of patients.[Table: see text]

Background: To study the effect of testosterone treatment on markers of inflammation in hypogonadal men with MS.Methods: 20 men with MS (IDF criteria) and LOH (total testosterone (TT) < 11 nmol/l) received 3 injections of testosterone undecanoate (Nebido) or placebo. Patients were divided into two groups according to TT levels 12 weeks after the third injection of Nebido/placebo: in group 1 (n = 13) TT was normalized to 15.75 [13.5-17.3] nmol/l and in group 2 (n = 7), TT was not normalized (8.3 [6.5-10.2] nmol/l). Interleukin-6 (IL-6), C-reactive protein (CRP) and tumor necrosis factor alpha (TNF alpha) were measured before and after 30 weeks. Statistical analysis was performed using Wilcoxon test.Results: In group 1, IL-6 decreased from 4.6 [3.0-3.8] to 3.8 [2.8-3.0] pg/ml (normal range (NR) < 4.1) (p = 0.04), TNF alpha decreased from 15.2 [12.3-15.3] to 12.2 [10.7-10.0] pg/ml (NR 0-8.21) (p = 0.005) and CRP decreased from 3.8 [1.4-4.1] to 1.9 [0.6-3.1] mg/L (NR 0-5) (p = 0.01). In group 2, there were no significant changes in IL-6, TNF alpha and CRP: IL-6 was 3.2 [2.8-3.2] and 3.2 [2.7-3.3] pg/ml (normal range (NR) < 4.1) (p = 1), TNF alpha was 13.2 [12.1-13.9] and 12.0 [11.5-12.1] pg/ml (NR 0-8.21) (p = 0.45) and CRP was 4.0 [0.6-6] and 4.9 [0.7-8.5] mg/L (NR 0-5) (p = 0.22) before and after 30 weeks of treatment, respectively.Conclusion: LOH correction in men with MS has beneficial effect on the process of chronic inflammation.17 Is sexual health the portal to men's health? -the experience of a primary men's health practice Background: The difference in health statistics between men and women is obvious in genderspecific medicine. Some of the reasons cited for this difference include men's attitude towards health and also a less than proactive approach of the medical community towards men's health. The Singapore Men's Health Clinic (SMHC) is a private community based men-only primary health care facility in practice since 2003. This study is to review the conditions that bring patients to the clinic and to examine the role the practice can play in men's health.Method: The presenting diagnoses of patients seen by the SMHC at locations where the clinic was first started and another after a move to new premises are reviewed. The case records of the first consecutive new patients seen in both locations for almost identical time periods (Location A: 17/11/03-17/06/04; Location B: 3/10/05-8/4/06) were retrieved. Relevant data are presented.Results: Fewer new patients were seen at B than at A (n = 140 vs. n = 482) although the hours of operation of the clinic were the same. The age distribution of patients was identical. Problems related to sexual health were the main diagnoses among patients at A and B (x 2 = 3.65) constituting 72.4% of all presenting

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