Effects of long-term treatment with the anti-androgen bicalutamide on human testis: an ultrastructural and morphometric study

Aims: To assess the effects of more than 4 years' treatment with the anti-a ndrogen bicalutamide on human testis by clinical, ultrastructural and morph ometric analysis. Methods and results: Two patients (aged 74 and 69 years) with prostate canc er were treated for more than 4 years with bicalutamide 50 mg daily. Clinic al characterization and follow-up included luteinizing hormone (LH), follic le-stimulating hormone (:FSH), testosterone and prostate-specific antigen ( PSA) measurements and clinical response of the tumours. Due to progression of the disease, patients underwent surgical orchidectomy as a further andro gen withdrawal therapy. Testis biopsies were studied by light and electron microscopy and analysed by morphometry. Control samples were obtained from the normal testis of two patients with testicular cancer who underwent orch idectomy. Clinical follow-up showed a good response in the control of tumou r growth and serum PSA decreased to <4 ng/mL: concentrations of serum LD, F SH and testosterone were within the normal range. Testicular morphology of treated patients was unexpectedly well preserved: the organization of semin iferous tubules was normal with all the germ line elements and mature sperm atozoa present. In some areas, a net increase of peritubular connective tis sue was evident which may be a consequence of the age of the patients. Conclusions: Long-term bicalutamide (50 mg) treatment appears to have very little impact on testis ultrastructure and sperm maturation, while it is ef fective in the control of androgen-dependent prostatic tumours.