Saturday, June 11, 2011

More evidence for the safety of testosterone replacement for men by Jerry Brainum

 This abstract is from the Endocrine Society 2011 meeting:

[P2-44] Testosterone Treatment in Elderly Hypogonadal Patients Does Not Increase Prostate Cancer Risk: Prospective Comparative 6-Year Follow-up Analysis with Age-Matched Controls

AA Yassin, AD-J Yassin, A Haider, F Saad. Institute of Urology & Andrology, Norderstedt-Hamburg, Germany; Asklepios Klinik Barmbek, Hamburg, Germany; Private Urologic Practice, Bremerhaven, Germany; Bayer Schering Pharma AG, Berlin, Germany.

Objective: Evaluation of prostate safety parameter including prevalence of prostate cancer in elderly hypogonadal subjects under testosterone treatment in comparison with age- and characteristic matched control groups.Methods: 154 testosterone deficient patients (average age 58 ± 1.7 years and mean follow-up of 42 months, range: 38-61 months), receiving inj. long-acting TU 1000 mg, compared to a control cohort of 160 eugonadal men (average age 59 ± 2.8 years) with similar characteristics visiting clinic for preventive medical check up. They underwent monitoring at baseline and 6-monthly including co-morbidities, concomitant medication, International Prostate Symptom Score (IPSS), prostate-specific antigen (PSA), digital rectal examination (DRE), total prostate volume and transitional zone measured by transrectal ultrasound (TRUS). TRUS-guided biopsies were performed when indicated by PSA velocity > 0.75 μg/L, or elevation over 4.0μg/L.
Results: At baseline, hypogonadal patients showed lower PSA values and lower prostate volumes(0.68 ± 0.4 μg/L and 25.6 ± 1.4 ml, respectively).Subjects in the control group had PSA levels of 2.42 ± 1.2 μg /L, and prostate volume 38.4 ± 2.42 ml at baseline. Hypogonadal patients whose PSA velocity in the observation period was > 0,75 μg /L, underwent TRUS-guided prostate biopsies (10 cores 2.2 cm each or saturating biopsies 24-32 cores 2.2 cm each in those men for whom a repeat biopsy was indicated). We found CaP in 5/22 biopsies, three of them unilateral with up to 10% tumor cells in a core. Gleason scores were 3+2 or 3+3. Two patients had a high grade prostate intra-epithelial neoplasia (PIN). In the 160 control subjects, 16/39 subjects who underwent biopsies showed CaP, 4 of them bilateral, with significantly higher Gleason score of 3+3 till 4+5 and up to 80% tumor cells in a core. No subject of both groups showed any abnormality in rectal palpation. Conclusions: Subjects with T-deficiency have lower prostate volumes and PSA levels than eugonadal ones. Testosterone therapy does not increase CaP incidence. The group on testosterone treatment had smaller tumors and less malignancy (better differentiation).Hypogonadism offers no protection against the development of biopsy-detectable prostate cancer. Lower levels of total testosterone or free testosterone were associated with an increased risk of cancer. Hypogonadal patients untreated with TRT could be at higher risk to have bigger and more aggressive prostate cancers.

©,2013 Jerry Brainum. Any reprinting in any type of media, including electronic and foreign is expressly prohibited.

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