Aim: Has testosterone undecanoat 1000 mg injection (NebidoR; 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, 1896 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=0.140.73). 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& 8391 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.
20 - 23 May 2017
European Society of Endocrinology