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Conference 2003

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ANDROGEN REPLACEMENT AND PROSTATE DISEASE, BENIGN AND MALIGNANT

Dr. Joel Kaufman,

Aurora Urology, P.C., Aurora, Colorado, USA.

Androgel is now the most widely prescribed androgen replacement in the U.S.  In this trial, as part of the FDA submission, 227 hypogonadal men received either Androgel 5 or 10 gm or Androderm patch 5 mg per day for 6 months and then all received Androgel for another 30 months.  All groups showed improvement in libido and erections. Although all groups showed improvement in serum testosterone levels, both Androgel groups significantly outperformed the Androderm patch. Improvements in muscle and lean body mass and bone growth were seen in the Androgel groups.  There were no significant changes in prostate symptom scores or uroflow; small changes were seen in PSA and only one man developed prostate cancer during the study.

In a review the literature on androgen replacement and BPH parameters as well as PSA, numerous studies have shown small changes in PSA which are not clinically significant.  Very few men have developed prostate cancer in these studies and androgens do not seem to worsen prostate symptoms. A review of the association between androgens and prostate cancer showed a few case reports of prostate cancer being identified in men receiving androgen therapy.   Fowler and Whitmore in 1982 reported administering testosterone to men with known metastatic prostate with no knowledge of their hormone status. A large number developed severe adverse reactions, and as a result. an absolute contraindication to administering testosterone to men with any history of prostate cancer developed.  Because of the fear that  men over 50 may harbor latent prostate cancer, physicians may be reluctant to screen for and treat hypogonadism.

Finally I will review my personal experience with hypogonadal men treated with radical prostatectomy for their prostate cancer. In all cases the pathology was favorable and the PSA was non-detectable. After discussing potential complications with these men they received testosterone replacement with improvement in clinical symptoms and no increase in PSA. An additional patient with severe hypogonadism after radiation therapy was cautiously administered Androgel with excellent response and no rise in PSA.  These cases support the concept that normalizing testosterone levels in hypogonadal men with prostate cancer may not exacerbate their cancers.

Dr. Joel Kaufman, MD

Aurora Urology, P.C.,

Aurora, Colorado, USA.

Email: JOELK1123@aol.com

Dr Kaufman graduated from Princeton University in 1965, Yale School of Medicine in 1969,and completed his residency at Yale in 1975. He has held academic appointments at Harvard, University of Colorado and South Carolina and was the chief of the Division of Urology at the University of South Carolina from 1980-1983.

Since then he has been in private practice in Aurora, Colorado and Associate Clinical Professor at the University of Colorado. He has authored 55 journal articles and for the last 17 years has specialized in Erectile Dysfunction.

He has been the Principal Investigator on more that 100 clinical trials, including Sildenafil, Vardenafil, Tadalafil, Apomorphine, Androgel and Edex and is on the Advisory Boards and Speakers Bureaus for Pfizer, Ully-lcos, Bayer, Solvay and Mentor. His paper on "Androgen Administration after Radical Prostatectomy in Hypogonadal Men with Prostate Cancer" will be presented in April at the American Urologic Association meeting in Chicago.