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Correspondence |

Finasteride (Propecia) and the Promotion of High-grade Prostate Cancer

W. Reid Pitts, Jr, MD
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Copyright 2004 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

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Arch Dermatol. 2004;140(7):885-886. doi:10.1001/archderm.140.7.885-b
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The phase 1 trials of finasteride (Propecia/Proscar; Merck) have shown that finasteride at 1 mg (Propecia) as well as finasteride at 5 mg (Proscar)blocks 5-α reductase.

The genetic, biochemical, epidemiological, experimental, and clinical reasons for my warning1 2 3years ago that use of finasteride promotes prostate cancer have been confirmed by the findings of a finasteride chemoprevention trial (Prostate Cancer PreventionTrial [PCPT]) involving 18 882 men followed up for 7 years. The trial was stopped after 9060 men underwent biopsy during the trial or at the endof 7 years.

It was found that "Finasteride prevents or delays the appearance of prostate cancer " by 24.6% (finasteride, 803/4368 [18.4%]; placebo, 1147/4692[24.4%]) but "increased the risk of high-grade prostate cancer (Grade 7, 8, 9, 10)" by 67% (finasteride, 280/757 [37%]; placebo, 237/1068 [22.2%] [P<.001]) in men diagnosed as having prostate cancer.3

Patrick Walsh, MD, stated in his critique of the PCPT that

there was a 68% increase in the frequency of high grade (Gleason 7-10) tumors in patients treated with finasteride (Propecia/Proscar) . . .At 7 years 52% of the tumors in the finasteride treated men were high grade vs 31% in the placebo group. . . . If one looks at the positive biopsy ratein the patients with an elevated PSA [prostate-specific antigen] or abnormal digital rectal examination (DRE) (i.e. biopsied "For Cause"), finasterideonly reduced the positive biopsy rate in those patients by 10% (29.5% placebo vs 26.5% finasteride).4

The "end of study" biopsies of the men who did not undergo biopsy during the 7 years (no PSA >4.0 ng/mL, no induration on DRE) showed a 60% increasein high-grade prostate cancer (finasteride, 92/364 [25.3%]; placebo, 89/564 [15.8%] [P<.001]). Even with intensive screening,high-grade prostate cancer was promoted without warning by finasteride (Propecia).3

The suggestion by Dr Peter Scardino in his editorial in the New England Journal of Medicine that young men (<35 years old) might have the "added benefit of cancer prevention" is not correct, as these menwill have the added risk for promoting high-grade prostate cancer for over 50 years while using finasteride, 1 mg (Propecia, 1 mg).5 Principalinvestigator Ian M. Thompson, MD, also confused the issue of low-dose finasteride (Propecia, 1 mg) and high-dose finasteride (Proscar, 5 mg)3 (Oncology Times. July 25, 2003, and August 10, 2003).

The PCPT was stopped in March 2003 because finasteride promoted high-grade (Gleason scores 7, 8, 9, 10) prostate cancer, as I had hypothesized.1 2

Male-pattern baldness may be treated with a number of topical drugs, such as minoxidil. Finasteride is of marginal benefit for alopecia. Dermatologistsshould heed the warnings of the PCPT and cease using Propecia (finasteride) and nonprescription blockers of "the bad body chemical DHT [dihydrotestosterone]"(eg, Hair Advantage, Avocor) for alopecia.

REFERENCES

Pitts Jr  WR. Chemoprevention of urological cancer [letter] J Urol. 2000;1631260- 1261
PubMed
CrossRef
Pitts Jr  WR. Prostatic intraepithelial neoplasia and putative precursor lesions of prostate cancer: a clinical perspective [letter] BJU Int. 2001;88985- 986
CrossRef
Thompson  IM, Goodman  PJ, Tangen  CM.  et al.  The influence of finasteride on the development of prostate cancer:Prostate Cancer Prevention Trial N Engl J Med. 2003;349215- 224
PubMed
CrossRef
Walsh  PC. The influence of finasteride on the development of prostate cancer[editorial comment] J Urol. 2004;171506- 507
CrossRef
Scardino  PT. The prevention of prostate cancer: the dilemma continues N Engl J Med. 2003;349297- 299
PubMed
CrossRef

AUTHOR INFORMATION

The author has no relevant financial interest in this letter.

Correspondence: Dr Pitts, 115 E 61st St, New York, NY 10021.

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Pitts Jr  WR. Chemoprevention of urological cancer [letter] J Urol. 2000;1631260- 1261
PubMed
CrossRef
Pitts Jr  WR. Prostatic intraepithelial neoplasia and putative precursor lesions of prostate cancer: a clinical perspective [letter] BJU Int. 2001;88985- 986
CrossRef
Thompson  IM, Goodman  PJ, Tangen  CM.  et al.  The influence of finasteride on the development of prostate cancer:Prostate Cancer Prevention Trial N Engl J Med. 2003;349215- 224
PubMed
CrossRef
Walsh  PC. The influence of finasteride on the development of prostate cancer[editorial comment] J Urol. 2004;171506- 507
CrossRef
Scardino  PT. The prevention of prostate cancer: the dilemma continues N Engl J Med. 2003;349297- 299
PubMed
CrossRef

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