Aim: Has testosterone undecanoat 1000 mg intramuscular injection (NebidoR; Bayer), 1 at 3month, negative effect on prostate? For this purpose, we appreciate the prostatic volume (see Pisoschi, this congress) and PSA (this study) in hypogonadic patients after testosterone injection up to 11 years.
Material and method: A. PSA (ng/ml) was done in Bucharest accredited laboratories.
B. Patients: PSA analysis was done before treatment and recorded every year from 1 year treatment to 11 years; in some patients PSA was done at 14 days, 3 and 6 months.
C. Statistical analysis: Student test, simple correlation, multiple regression.
Results: A. Patients at onset: 279 men, age: 1896 years, average: 59,67 years; median: 61.
B. Prostatic volume (cmc): average: 33,74.
C. Average PSA (no patients): before treatment =1,55 (279); [14d=1,73 (59); 3m=2,76 (60); 6m=1,46 (54)]; 1y=1,76 (143); 2y=1,48 (104); 3y=1,48 (72); 4y=1,7 (60); 5y=1,52 (54); 6y=1,75 (42); 7y=1,7 (35); 8y=1,73 (27); 9y=2,1 (16), 10 y=1,28 (9), 11 y=1,81 (5).
D. Statistical difference of averages from 1y to 11 y: nonsignificant for all times: p= between 0,46-0,84.
E. Correlation between age and PSA was significant (P<0,05) at: T0: r=0,34; and 1y: r=0,19; and nonsignificant at 2 years to 11 years (r=0.160.68). Significance is depending on group size.
F. Correlation between PSA and prostatic volume was significant, both before and after treatment at 1, 2, 3, 4, 8, 9 years (depending on group size, r=0.20.52).
G. Multiple regression test shows the relationships between PSA before/after treatment, prostatic volume before/after treatment and the impact of testosterone on PSA and prostatic volume. Statistical significance: P values < 0.01 for all years (including 5 data for 11 year treatment: P=0.015): R2 =0.320.99, F=3,241584.
Comments. Comparing with 2017 (Lisbon Congress) data, patient number increased by 15%.
Conclusions: 1. Testosterone undecanoat 1000 mg injectable i.m. at 3 months did not increased PSA level after up to 11 years administrations.
2. Based on multiple regression data, PSA level post testosterone does not depend on testosterone administration but on the age and the prostatic volume before treatment and depend on the initial PSA level, i.e. before testosterone administration.
18 - 21 May 2019
European Society of Endocrinology