Prostate cancer in 671 hypogonadal men with and without long-term testosterone treatment: Results from a controlled registry study.
33 Background: Despite persisting concerns, there is no evidence that TTh in men with hypogonadism increases PCa incidence or severity. Rather, 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: 375 men (age range: 33-70) 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: 7 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 regularly every 3-6 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, 8 men (2.1%) were diagnosed with PCa. In CTRL, 12 (4.1%) were diagnosed with PCa. The incidence per 10,000 years was 32 in the T-group and 64 in CTRL. The mean baseline age of PCa patients was 65 years in both groups. Prostatectomy was performed in all men. In the T-group, all patients had a Gleason score ≤ 6 and a predominant Gleason score of 3. Tumor grade was G2 in all 8 (100%), tumor stage T2a in 6 (75%) and T2b in 2 (25%) patients. In CTRL, Gleason score was > 6 in all 12 patients. Three men had a predominant Gleason score of 3, 8 had 4, and 1 had 5. Tumor grade was G2 in 5 (41.7%) and G3 in 7 (58.3%) patients, tumor stage T2b in 1 (8.3%), T2c in 1 (8.3%), T3b in 4 (33.3%) and T3c in 6 (50%) patients. Conclusions: TTh in hypogonadal men regularly monitored may decrease incidence of PCa compared to hypogonadal CTRL. PCa was less severe in the T-group. Weight loss and reduced inflammation by TTh may have contributed to our findings.