Endocrine Abstracts

Aim: Has testosterone undecanoat 1000 mg injection (Nebido^R; Bayer), 1/3month negative effect on prostate?

Material and method: i) PSA (ng/ml) was registred retrospective (from files) and prospective analysis (onset 2010). ii) Patients: PSA analysis was done before treatment and recorded at T1 to T12 [2 weeks to 9 years] (see Pisoschi, this Congress). iii) Statistical analysis: Student test, simple correlation, multiple regression.

Results: A. Patients at onset: 160 men, 18–96 years, average: 60.38; median: 60; no prostatic cancer. B. Prostatic volume (cmc): average: 34.81. C. Average PSA (no patients): before treatment =1.60 (160); 1y=1.69 (110); 2y=1.4 (83); 3y=1.85 (57); 4y=2 (46); 5y=1.86 (34); 6y=1.51 (30); 7y=2.86 (2); 8y=1.99 (11); 9y=1.90 (4). D. Statistical difference of increasing average: nonsignificant for all times from 2 weeks to 9 years. E. Correlation between age and PSA was 1. significant at: T0: r=0.29; 1y: r=0.35; 2y r=0.28. 2. nonsignificant for 3 to 9 years (r=0.14–0.73). F. Correlation between PSA and prostatic volume was significant, both before and after treatment (depending on group size). G. Observations: 7 patients died; 1 during treatment, Klinefelter, 41 y, cerebral tumor; remaining 6 after 2 years stoping tretament, 60& 83–91 y, most cardiac stop. H. Multiple regression test shows p values <<0.001 for all years (examples): 1y: R² =0.58, F=50.24 → 9y: R² =1, F=>1000.

Conclusions: i) Testosterone undecanoat 1000 mg injectable i.m. at 3 months did not increased PSA level after up to 9 years administrations. ii) PSA level post testosterone does not depend on testosterone administration but on age, prostatic volume, before and after treatment, and initial PSA level, i.e. before testosterone administration.