Prostate cancer (PCa) in 696 hypogonadal men with and without long-term testosterone therapy (TTh): Results from a controlled registry study.

Abstract

5085 Background: There is no evidence that TTh in men with hypogonadism increases PCa incidence or severity. A Canadian group recently found that long-term TTh decreased the risk of PCa diagnosis (Wallis et al., Lancet Diab Endocrinol 2016; 4:498). We assessed incidence and severity of PCa in hypogonadal men on long-term TTh (T-group) in comparison to an untreated hypogonadal control group (CTRL). Methods: 400 men with testosterone ≤350 ng/dL and symptoms received testosterone undecanoate 1000 mg every 3 months for up to 10 years. 296 hypogonadal men (57-74) opted against TTh. Median follow-up: 8 years. Total observation time covered more than 5,000 patient-years. Prostate volume (PV), PSA, weight and C-reactive protein (CRP) were measured and digital rectal examination/transrectal ultrasound performed before treatment initiation and then every 6-12 months. Biopsies were performed when indicated according to EAU guidelines. Results: In the T-group, PV increased slightly but significantly by 2.41 mL (p < 0.0001), PSA by 0.22 (NS). In CTRL, PV decreased slightly but significantly by -1.20 mL (p < 0.005), PSA by -0.38 (p < 0.0001). Weight dropped by 18.23% in the T-group and increased by 1.78% in CTRL, CRP decreased significantly in the T-group and remained unchanged in CTRL. In the T-group, 9 men (2.3%) were diagnosed with PCa. In CTRL, 15 (5.1%) were diagnosed with PCa. The incidence per 10,000 years was 29 in the T-group and 102 in CTRL. The mean baseline age of PCa patients was 65 years in the T-group and 65.5 in CTRL. Prostatectomy was performed in all men. In the T-group, all but 1 patient had a Gleason score ≤6, and all a predominant Gleason score of 3. Tumor grade was G2 in all 9 (100%), tumor stage T2a in 7 (78%) and T2b in 2 (22%) patients. In CTRL, Gleason score was > 6 in all 15 patients. 4 men had a predominant Gleason score of 3, 10 had 4, and 1 had 5. Tumor grade was G2 in 7 (46.7%) and G3 in 8 (53.3%) patients, tumor stage T2b in 1 (6.7%), T2c in 1 (6.7%), T3a in 1 (6.7%), T3b in 7 (46.7%) and T3c in 6 (50%) patients. Conclusions: In hypogonadal men, TTh may decrease PCa incidence compared to CTRL. PCa was less severe in the T-group. Weight loss and reduced inflammation by TTh may have contributed to our findings.