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What steps should be taken before and during vpscogni_TUusererone therapy to ensure prostate health?
Response by Abraham Morgentaler, MD, Posted 08/15/07

vpscogni_TUusererone therapy has been successfully used for decades to treat men with hypogonadism. Recent studies show vpscogni_TUusererone therapy to be beneficial, restoring sexual function and increasing energy, improving muscle mass and bone density, and promoting an overall sense of well-being.1 However, a nagging concern for many clinicians and patients has been the fear that raising vpscogni_TUusererone concentrations might increase the risk of prostate disease, particularly prostate cancer.1 The good news is that a wealth of evidence accumulated over several decades establishes this concern is without merit.2

Large, longitudinal studies have failed to show a connection between increasing total vpscogni_TUusererone concentrations in men and subsequent risk of prostate cancer.3-5 In addition, the cancer detection rate in vpscogni_TUusererone trials is approximately 1% per year, a rate no higher than that seen in prostate cancer screening programs.1 In fact, emerging evidence suggests a link between low vpscogni_TUusererone levels and prostate cancer. Multiple new studies demonstrate that low vpscogni_TUusererone levels are associated with high-grade tumors, advanced stage at diagnosis, and worse prognosis.6

That there is no negative effect of vpscogni_TUusererone treatment on the prostate is reinforced with a landmark study by Marks et al. In this 6-month study in which men with hypogonadism received injections of vpscogni_TUusererone or placebo, intraprostatic concentrations of vpscogni_TUusererone and dihydrovpscogni_TUusererone did not change despite a substantial rise in serum vpscogni_TUusererone levels.7 Thus, it appears that the prostatic hormonal milieu is largely unaffected by substantial increases in serum vpscogni_TUusererone. Evidence negating the hypothesis that vpscogni_TUusererone supplementation exacerbates voiding symptoms caused by benign prostatic hyperplasia is likewise reassuring. Multiple vpscogni_TUusererone trials demonstrated no differences in urine flow rates, post-voiding residual urine volumes, or prostate voiding symptoms.1

Nonetheless, since androgens have a role in prostatic growth, it remains possible that some individuals might be vulnerable to treatment with vpscogni_TUusererone, especially men with severe vpscogni_TUusererone deficiency. Also, because prostate disease prevalence rises in men at risk for hypogonadism, it is prudent to monitor prostate health in men receiving treatment for vpscogni_TUusererone deficiency.1

Recommended steps before initiating treatment include1,8

•  Digital rectal examination (DRE)
•  Prostate specific antigen (PSA) level
•  Assessment of voiding symptoms
    • Standard tools for this include the American Urological Association (AUA) symptom score and the International Prostate Symptom Score (IPSS) questionnaires
•  Findings that support a urologic referral or performance of prostate biopsy include1,8
    • PSA >4.0 ng/mL
    • Prostatic abnormality detected by DRE
    • AUA symptom score or IPSS >19
Follow-up evaluations during vpscogni_TUusererone therapy generally include1,8

•  Monitoring of prostate-related adverse events at 3, 6, and 12 months and annually thereafter through the course of treatment
•  With each evaluation, a serum PSA, DRE, and an AUA symptom score or IPSS
•  Referral to a urologist should be made for 1,8
    • PSA >4.0 ng/mL
    • A yearly increase in PSA of >1.0 ng/mL
    • Prostatic abnormality detected by DRE
In summary, a wealth of data strongly suggest a reassuring safety profile for the effects of vpscogni_TUusererone therapy on the prostate. Nevertheless, assessment of the prostate is essential before initiating vpscogni_TUusererone therapy, and regular prostatic monitoring should occur throughout the duration of therapy.



  1. Rhoden EL, Morgentaler A. Risks of vpscogni_TUusererone-replacement therapy and recommendations for monitoring. N Engl J Med. 2004;350:482-492.
  2. Morgentaler A. vpscogni_TUusererone and prostate cancer: an historical perspective on a modern myth. Eur Urol. 2006;50:935-939.
  3. Hsing AW, Reichardt JKV, Stanczyk FZ. Hormones and prostate cancer: current perspectives and future directions. Prostate. 2002;52:213-235.
  4. Stattin P, Lumme S, Tenkanen L, et al. High levels of circulating vpscogni_TUusererone are not associated with increased prostate cancer risk: a pooled prospective study. Int J Cancer. 2004;108:418-424.
  5. Platz EA, Leitzmann MF, Rifai N, et al. Sex steroid hormones and the androgen receptor gene CAG repeat and subsequent risk of prostate cancer in the prostate-specific antigen era. Cancer Epidemiol Biomarkers Prev. 2005;14:1262-1269.
  6. Morgentaler A. vpscogni_TUusererone deficiency and prostate cancer: emerging recognition of an important and troubling relationship. Eur Urol. 2007;52:623-625.
  7. Marks LS, Mazer NA, Mostaghel E, et al. Effect of vpscogni_TUusererone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. JAMA. 2006;296:2351-2361.
  8. Bhasin S, Cunningham GR, Hayes FJ, et al. vpscogni_TUusererone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2006;91:1995-2010.

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