Prostate cancer (PCa) incidence and severity in 821 hypogonadal men with and without testosterone therapy (TTh) in a controlled, observational registry implying more than 7,000 patient-years.

Abstract

304 Background: Guidelines by AUA and EAU state that there is no evidence for an increased PCa risk for testosterone (T) treatment in hypogonadal men. Methods: In a registry study initiated in 2004 in a urology practice, 428 hypogonadal men (T≤350 ng/dL) received T undecanoate 1000 mg every 3 months following an initial 6-month interval for up to 13 years (T-group). 393 hypogonadal men (age range 51-74) opted against TTh (CTRL). Suspicion of or active PCa was excluded by transrectal ultrasound, digital rectal examination and PSA before treatment/observation initiation. Examinations were repeated between one and four times per year. Biopsies were performed when indicated according to EAU Guidelines. Results: In the T-group, 12 (2.8%) , in CTRL, 42 men (10.9%) were diagnosed with PCa. The mean baseline age of PCa patients was 64.9 years in the T-group and 64 in CTRL.In the T-group, the average time span between day of first injection and positive biopsy was 14.2 months (range: 5-18). No patient was diagnosed with PCa beyond 18 months of TTh. In CTRL, PCa was diagnosed at any time during the observation time. In the T-group, radical prostatectomy (RP) was performed in all men. All but 3 patients had Gleason score (GS) ≤6, and all but 1 had a primary GS of 3. Tumor grade was G2 in all 12 (100%), tumor stage T2a in 7 (58%), T2b in 3 (25%), and T2c in 2 (17%) patients. All but 2 patients are back on TTh after an average time of 25 months. In CTRL, RP was performed in all but 6 patients who received radiation therapy (RT). GS was ≤6 in 2 patients, 7 men had a GS of 7, 21 a GS of 8, and 12 a GS of 9. 4 men had a primary Gleason score of 3, 29 had 4, and 9 had 5. Tumor grade was G2 in 9 (21%) and G3 in 33 (79%) patients, tumor stage T2a in 2 (5%), T2c in 1 (2%), T3b in 15 (36%) and T3c in 24 (57%) patients. In CTRL, biochemical recurrence occurred in 11 (26%) patients. These patients received androgen deprivation therapy (ADT). 12 (34%) patients died of whom 7 were on ADT. In the T-group, no biochemical recurrences or deaths occurred during the observation time. Conclusions: Less PCa occurred and severity was lower in testosterone-treated hypogonadal patients compared to untreated hypogonadal controls.