MedKoo product information:

 Finasteride 

Finasteride (marketed by Merck under the trademark names Proscar and Propecia, among other generic names) is a synthetic antiandrogen that inhibits type II 5-alpha reductase, the enzyme that converts testosterone to dihydrotestosterone (DHT). Finasteride is approved for the treatment of benign prostatic hyperplasia (BPH) and male pattern baldness (MPB).

Merck is currently developing finasteride for  prevention of prostate cancer.  The FDA has added warning to finasteride about an increased risk of high-grade prostate cancer. Whilst the potential for positive, negative or neutral changes to the potential risk of developing prostate cancer with finasteride has not been established, evidence has suggested it may temporarily reduce the growth and prevalence of benign prostate tumors, but could also mask the early detection of prostate cancer. The primary area for concern is for patients who may develop prostate cancer whilst taking finasteride for benign prostatic hyperplasia, which in turn could delay diagnosis and early treatment of the prostate cancer, thereby potentially increasing the risk of these patients developing high-grade prostate cancer.

The 2005 Prostate Cancer Prevention Trial (PCPT) showed at a dosage of 5 mg per day, as is commonly prescribed for BPH, participants taking finasteride were 25% less likely to have developed prostate cancer at the end of the trial compared to those taking a placebo.[9] It appeared (incorrectly) that finasteride increased the specificity and selectivity of prostate cancer detection, thus creating an apparently increased rate of high Gleason grade tumor. A 2008 update of this study found that finasteride reduces the incidence of prostate cancer by 30%. In the original study, it turns out that the smaller prostate caused by finasteride means that a doctor is more likely to hit upon cancer nests and more likely to find aggressive looking cells. Most of the men in the study who had both low and high-grade prostate cancer chose to be treated, and many had their prostates removed. A pathologist then carefully examined each of those 500 prostates and compared the kinds of cancers found at surgery to those initially diagnosed at biopsy. This study concluded that finasteride did not increase the risk of high-grade prostate cancer. (source: http://en.wikipedia.org/wiki/Finasteride).

Current developer:    Merck

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2: Montironi R, Bartels PH, Decensi A, Puntoni M, Hurle R, Decobelli O, Carmignani G, Mazzucchelli R, Bartels HG, Alberts DS, Maffezzini M. A randomized phase IIb presurgical study of finasteride vs. low-dose flutamide vs. placebo in men with prostate cancer. Efficacy monitored by karyometry☆. Urol Oncol. 2011 Jul 21. [Epub ahead of print] PubMed PMID: 21783387.

3: Hsieh JT, Chen SC, Yu HJ, Chang HC. Finasteride upregulates expression of androgen receptor in hyperplastic prostate and LNCaP cells: implications for chemoprevention of prostate cancer. Prostate. 2011 Jul;71(10):1115-21. doi: 10.1002/pros.21325. Epub 2011 Jan 12. PubMed PMID: 21557276.

4: Finasteride: male breast cancer. Prescrire Int. 2010 Dec;19(111):283. PubMed PMID: 21355383.

5: Oderda M, Zitella A, Richiardi L, Tizzani A, Gontero P. Effect of finasteride on the sensitivity of PSA to detect prostate cancer in rebiopsy series. Arch Ital Urol Androl. 2010 Dec;82(4):135-8. PubMed PMID: 21341547.

6: Reed SD, Scales CD Jr, Stewart SB, Sun J, Moul JW, Schulman KA, Xu J. Effects of family history and genetic polymorphism on the cost-effectiveness of chemoprevention with finasteride for prostate cancer. J Urol. 2011 Mar;185(3):841-7. Epub 2011 Jan 15. PubMed PMID: 21239023; PubMed Central PMCID: PMC3059593.

7: Hsieh JT, Chen SC, Yu HJ, Chang HC. Finasteride upregulates expression of androgen receptor in hyperplastic prostate and LNCaP cells: Implications for chemoprevention of prostate cancer. Prostate. 2011 Jan 12. [Epub ahead of print] PubMed PMID: 21229554.

8: Hulin-Curtis SL, Petit D, Figg WD, Hsing AW, Reichardt JK. Finasteride metabolism and pharmacogenetics: new approaches to personalized prevention of prostate cancer. Future Oncol. 2010 Dec;6(12):1897-913. Review. PubMed PMID: 21142863.

9: Shenoy NK, Prabhakar SM. Finasteride and Male Breast Cancer: Does the MHRA Report Show a Link? J Cutan Aesthet Surg. 2010 May;3(2):102-5. PubMed PMID: 21031070; PubMed Central PMCID: PMC2956950.

10: Lynn R, Krunic A. Therapeutic hotline. Treatment of androgenic alopecia with finasteride may result in a high grade prostate cancer in patients: fact or fiction? Dermatol Ther. 2010 Sep-Oct;23(5):544-6. doi: 10.1111/j.1529-8019.2010.01358.x. Review. PubMed PMID: 20868409.

11: Hamilton RJ, Kahwati LC, Kinsinger LS. Knowledge and use of finasteride for the prevention of prostate cancer. Cancer Epidemiol Biomarkers Prev. 2010 Sep;19(9):2164-71. Epub 2010 Aug 10. PubMed PMID: 20699373.

12: Locke JA, Bruchovsky N. Prostate cancer: finasteride extends PSA doubling time during intermittent hormone therapy. Can J Urol. 2010 Jun;17(3):5162-9. PubMed PMID: 20566007.

13: Groves-Kirkby N. Chemotherapy: Optimizing finasteride chemoprevention for prostate cancer. Nat Rev Clin Oncol. 2010 May;7(5):242. PubMed PMID: 20432528.

14: Neuhouser ML, Till C, Kristal A, Goodman P, Hoque A, Platz EA, Hsing AW, Albanes D, Parnes HL, Pollak M. Finasteride modifies the relation between serum C-peptide and prostate cancer risk: results from the Prostate Cancer Prevention Trial. Cancer Prev Res (Phila). 2010 Mar;3(3):279-89. Epub 2010 Feb 23. PubMed PMID: 20179296.

15: Vickers AJ, Savage CJ, Lilja H. Finasteride to prevent prostate cancer: should all men or only a high-risk subgroup be treated? J Clin Oncol. 2010 Mar 1;28(7):1112-6. Epub 2010 Feb 1. PubMed PMID: 20124185; PubMed Central PMCID: PMC2834464.

16: Lebdai S, Bigot P, Azzouzi AR. High-grade prostate cancer and finasteride. BJU Int. 2010 Feb;105(4):456-9. Epub 2009 Nov 20. Review. PubMed PMID: 19930174.

17: Murtola TJ, Tammela TL, Määttänen L, Ala-Opas M, Stenman UH, Auvinen A. Prostate cancer incidence among finasteride and alpha-blocker users in the Finnish Prostate Cancer Screening Trial. Br J Cancer. 2009 Sep 1;101(5):843-8. Epub 2009 Aug 4. PubMed PMID: 19654575; PubMed Central PMCID: PMC2736846.

18: Gong Z, Kristal AR, Schenk JM, Tangen CM, Goodman PJ, Thompson IM. Alcohol consumption, finasteride, and prostate cancer risk: results from the Prostate Cancer Prevention Trial. Cancer. 2009 Aug 15;115(16):3661-9. PubMed PMID: 19598210; PubMed Central PMCID: PMC2739798.

19: Finasteride to prevent prostate cancer: a new chapter. Harv Mens Health Watch. 2009 Jun;13(11):1-4. PubMed PMID: 19579321.

20: Tarle M, Spajic B, Kraljic I, Kusic Z. Continuous finasteride therapy for benign prostate hypertrophy upgrades both neuroendorcine differentiation and aggressive prostate cancer. Anticancer Res. 2009 May;29(5):1797-801. PubMed PMID: 19443407.

21: Kaplan SA, Roehrborn CG, Meehan AG, Liu KS, Carides AD, Binkowitz BS, Heyden NL, Vaughan ED Jr. PCPT: Evidence that finasteride reduces risk of most frequently detected intermediate- and high-grade (Gleason score 6 and 7) cancer. Urology. 2009 May;73(5):935-9. Epub 2009 Mar 28. PubMed PMID: 19328538.

22: Bañez LL, Blake GW, McLeod DG, Crawford ED, Moul JW. Combined low-dose flutamide plus finasteride vs low-dose flutamide monotherapy for recurrent prostate cancer: a comparative analysis of two phase II trials with a long-term follow-up. BJU Int. 2009 Aug;104(3):310-4. Epub 2009 Feb 23. PubMed PMID: 19239458.

23: Edwards JL. Finasteride and high-grade prostate cancer. Cancer Prev Res (Phila). 2009 Feb;2(2):185; author reply 185. Epub 2009 Jan 27. PubMed PMID: 19174583.

24: Redman MW, Tangen CM, Goodman PJ, Lucia MS, Coltman CA Jr, Thompson IM. Finasteride does not increase the risk of high-grade prostate cancer: a bias-adjusted modeling approach. Cancer Prev Res (Phila). 2008 Aug;1(3):174-81. Epub 2008 May 18. PubMed PMID: 19138953; PubMed Central PMCID: PMC2844801.

25: Anitha B, Inamadar AC, Ragunatha S. Finasteride-its impact on sexual function and prostate cancer. J Cutan Aesthet Surg. 2009 Jan;2(1):12-6. PubMed PMID: 20300365; PubMed Central PMCID: PMC2840927.

26: Bass R, Perry B, Langenstroer P, Thrasher JB, Dennis KL, Tawfik O, Holzbeierlein J. Effects of short-term finasteride on apoptotic factors and androgen receptors in prostate cancer cells. J Urol. 2009 Feb;181(2):615-9; discussion 619-20. Epub 2008 Dec 16. PubMed PMID: 19091346.

27: Shepherd BE, Redman MW, Ankerst DP. Does Finasteride Affect the Severity of Prostate Cancer? A Causal Sensitivity Analysis. J Am Stat Assoc. 2008 Dec 1;103(484):1392-1404. PubMed PMID: 20526381; PubMed Central PMCID: PMC2880822.

28: Vastag B. Preventing prostate cancer: new analyses put finasteride back on the map. J Natl Cancer Inst. 2008 Aug 20;100(16):1132-3. Epub 2008 Aug 11. PubMed PMID: 18695128.

29: Finasteride for prevention of prostate cancer. Med Lett Drugs Ther. 2008 Jun 30;50(1289):49-50. PubMed PMID: 18583946.

30: Thompson IM, Tangen CM, Parnes HL, Lippman SM, Coltman CA Jr. Does the level of prostate cancer risk affect cancer prevention with finasteride? Urology. 2008 May;71(5):854-7. PubMed PMID: 18455628; PubMed Central PMCID: PMC2692669.

31: Chen X, Gardner ER, Price DK, Figg WD. Development and validation of an LC-MS assay for finasteride and its application to prostate cancer prevention trial sample analysis. J Chromatogr Sci. 2008 Apr;46(4):356-61. PubMed PMID: 18402729; PubMed Central PMCID: PMC2629556.

32: Golbano JM, Lóppez-Aparicio P, Recio MN, Pérez-Albarsanz MA. Finasteride induces apoptosis via Bcl-2, Bcl-xL, Bax and caspase-3 proteins in LNCaP human prostate cancer cell line. Int J Oncol. 2008 Apr;32(4):919-24. PubMed PMID: 18360719.

33: Greene D, Page T. Why do men who receive finasteride have an increased prevalence of high-grade prostate cancer? Nat Clin Pract Urol. 2008 Mar;5(3):130-1. Epub 2008 Feb 5. PubMed PMID: 18253112.

34: Song Y, Tangen C, Goodman P, Parnes HL, Lucia MS, Thompson IM, Kristal AR. Finasteride, prostate cancer, and weight gain: evidence for genetic or environmental factors that affect cancer outcomes during finasteride treatment. Prostate. 2008 Feb 15;68(3):281-6. PubMed PMID: 18163420.

35: Lucia MS, Epstein JI, Goodman PJ, Darke AK, Reuter VE, Civantos F, Tangen CM, Parnes HL, Lippman SM, La Rosa FG, Kattan MW, Crawford ED, Ford LG, Coltman CA Jr, Thompson IM. Finasteride and high-grade prostate cancer in the Prostate Cancer Prevention Trial. J Natl Cancer Inst. 2007 Sep 19;99(18):1375-83. Epub 2007 Sep 11. PubMed PMID: 17848673.

36: Cohen YC, Liu KS, Heyden NL, Carides AD, Anderson KM, Daifotis AG, Gann PH. Detection bias due to the effect of finasteride on prostate volume: a modeling approach for analysis of the Prostate Cancer Prevention Trial. J Natl Cancer Inst. 2007 Sep 19;99(18):1366-74. Epub 2007 Sep 11. PubMed PMID: 17848668.

37: Thompson IM, Pauler Ankerst D, Chi C, Goodman PJ, Tangen CM, Lippman SM, Lucia MS, Parnes HL, Coltman CA Jr. Prediction of prostate cancer for patients receiving finasteride: results from the Prostate Cancer Prevention Trial. J Clin Oncol. 2007 Jul 20;25(21):3076-81. PubMed PMID: 17634486.

38: de Vere White RW. Finasteride for chemoprevention of prostate cancer: why has it not been embraced? J Clin Oncol. 2007 Jul 20;25(21):2999-3000. PubMed PMID: 17634478.

39: Klein EA. Are PSA adjustments necessary for prostate cancer screening in men taking finasteride for hair loss? Nat Clin Pract Urol. 2007 Aug;4(8):412-3. Epub 2007 Jun 12. PubMed PMID: 17563780.

40: Thompson IM, Tangen CM, Goodman PJ, Lucia MS, Parnes HL, Lippman SM, Coltman CA Jr. Finasteride improves the sensitivity of digital rectal examination for prostate cancer detection. J Urol. 2007 May;177(5):1749-52. PubMed PMID: 17437804.

41: Murtola TJ, Tammela TL, Määttänen L, Hakama M, Auvinen A. Prostate cancer risk among users of finasteride and alpha-blockers - a population based case-control study. Eur J Cancer. 2007 Mar;43(4):775-81. Epub 2007 Jan 23. PubMed PMID: 17251005.

42: D'Amico AV, Barry MJ. Prostate cancer prevention and finasteride. J Urol. 2006 Nov;176(5):2010-2; discussion 2012-3. Review. PubMed PMID: 17070238.

43: Khan MA, Partin AW. Finasteride and prostate cancer. Rev Urol. 2004 Spring;6(2):97-8. PubMed PMID: 16985587; PubMed Central PMCID: PMC1472822.

44: Thompson IM, Chi C, Ankerst DP, Goodman PJ, Tangen CM, Lippman SM, Lucia MS, Parnes HL, Coltman CA Jr. Effect of finasteride on the sensitivity of PSA for detecting prostate cancer. J Natl Cancer Inst. 2006 Aug 16;98(16):1128-33. PubMed PMID: 16912265.

45: Fleshner N, Kulkarni G. Should finasteride be used to prevent prostate cancer? Curr Treat Options Oncol. 2006 Sep;7(5):346-54. Review. PubMed PMID: 16904051.

46: Goetzl MA, Holzbeierlein JM. Finasteride as a chemopreventive agent in prostate cancer: impact of the PCPT on urologic practice. Nat Clin Pract Urol. 2006 Aug;3(8):422-9. Review. PubMed PMID: 16902518.

47: Walsh PC. Re: Long-term effects of finasteride on prostate specific antigen levels: results from the Prostate Cancer Prevention Trial. J Urol. 2006 Jul;176(1):409-10; author reply 410. PubMed PMID: 16753454.

48: Canby-Hagino ED, Brand TC, Hernandez J, Thompson IM. Chemoprevention of prostate cancer with finasteride. Expert Opin Pharmacother. 2006 May;7(7):899-905. Review. PubMed PMID: 16634712.

49: Grover S, Lowensteyn I, Hajek D, Trachtenberg J, Coupal L, Marchand S. Do the benefits of finasteride outweigh the risks in the prostate cancer prevention trial? J Urol. 2006 Mar;175(3 Pt 1):934-8; discussion 938. PubMed PMID: 16469585.

50: Eggener SE, Stern JA, Jain PM, Oram S, Ai J, Cai X, Roehl KA, Wang Z. Enhancement of intermittent androgen ablation by "off-cycle" maintenance with finasteride in LNCaP prostate cancer xenograft model. Prostate. 2006 Apr 1;66(5):495-502. PubMed PMID: 16372330.

51: Rubin MA, Allory Y, Molinié V, Leroy X, Faucon H, Vacherot F, Huang W, Kuten A, Salomon L, Rebillard X, Cussenot O, Abbou C, de la Taille A. Effects of long-term finasteride treatment on prostate cancer morphology and clinical outcome. Urology. 2005 Nov;66(5):930-4. PubMed PMID: 16286097.

52: Etzioni RD, Howlader N, Shaw PA, Ankerst DP, Penson DF, Goodman PJ, Thompson IM. Long-term effects of finasteride on prostate specific antigen levels: results from the prostate cancer prevention trial. J Urol. 2005 Sep;174(3):877-81. Erratum in: J Urol. 2005 Nov;174(5):2071. PubMed PMID: 16093979.

53: Zeliadt SB, Etzioni RD, Penson DF, Thompson IM, Ramsey SD. Lifetime implications and cost-effectiveness of using finasteride to prevent prostate cancer. Am J Med. 2005 Aug;118(8):850-7. PubMed PMID: 16084177.

54: Mellon JK. The finasteride prostate cancer prevention trial (PCPT)--what have we learned? Eur J Cancer. 2005 Sep;41(13):2016-22. Review. PubMed PMID: 16061372.

55: Carver BS, Kattan MW, Scardino PT, Eastham JA. Gleason grade remains an important prognostic predictor in men diagnosed with prostate cancer while on finasteride therapy. BJU Int. 2005 Mar;95(4):509-12. PubMed PMID: 15705069; PubMed Central PMCID: PMC1939940.

56: Pitts WR Jr. Finasteride (Propecia) and the promotion of high-grade prostate cancer. Arch Dermatol. 2004 Jul;140(7):885-6. PubMed PMID: 15262708.

57: Pitts WR Jr. Re: Thompson IM, Klein EA, Lippman SM, Coltman CA, Djavan B. Prevention of prostate cancer with finasteride: US/European perspective. Eur Urol 2003;44:650-5. Eur Urol. 2004 Jul;46(1):133-4. PubMed PMID: 15183559.

58: Bostwick DG, Qian J, Civantos F, Roehrborn CG, Montironi R. Does finasteride alter the pathology of the prostate and cancer grading? Clin Prostate Cancer. 2004 Mar;2(4):228-35. Review. PubMed PMID: 15072606.

59: Reddy GK. Finasteride, a selective 5-alpha-reductase inhibitor, in the prevention and treatment of human prostate cancer. Clin Prostate Cancer. 2004 Mar;2(4):206-8. Review. PubMed PMID: 15072601.

60: Lee SC, Ellis RJ. Male breast cancer during finasteride therapy. J Natl Cancer Inst. 2004 Feb 18;96(4):338-9. PubMed PMID: 14970289.

61: Rubin MA, Kantoff PW. Effect of finasteride on risk of prostate cancer: how little we really know. J Cell Biochem. 2004 Feb 15;91(3):478-82. Review. PubMed PMID: 14755678.

62: Thompson IM, Klein EA, Lippman SM, Coltman CA, Djavan B. Prevention of prostate cancer with finasteride: US/European perspective. Eur Urol. 2003 Dec;44(6):650-5. Review. PubMed PMID: 14644115.

63: Barqawi AB, Moul JW, Ziada A, Handel L, Crawford ED. Combination of low-dose flutamide and finasteride for PSA-only recurrent prostate cancer after primary therapy. Urology. 2003 Nov;62(5):872-6. PubMed PMID: 14624911.

64: Wise AM, Stevermer JJ. Does finasteride prevent prostate cancer? J Fam Pract. 2003 Nov;52(11):833, 837. PubMed PMID: 14599370.

65: Preventing prostate cancer with finasteride: a mixed blessing. Harv Mens Health Watch. 2003 Oct;8(3):1-3. PubMed PMID: 14576014.

66: Schwartz DT. Prevention of prostate cancer with finasteride. N Engl J Med. 2003 Oct 16;349(16):1569-72; author reply 1569-72. PubMed PMID: 14562808.

67: Ross RK, Skinner E, Cote RJ. Prevention of prostate cancer with finasteride. N Engl J Med. 2003 Oct 16;349(16):1569-72; author reply 1569-72. PubMed PMID: 14562807.

68: Burke HB. Prevention of prostate cancer with finasteride. N Engl J Med. 2003 Oct 16;349(16):1569-72; author reply 1569-72. PubMed PMID: 14562806.

69: Lee SC, Ellis RJ. Prevention of prostate cancer with finasteride. N Engl J Med. 2003 Oct 16;349(16):1569-72; author reply 1569-72. PubMed PMID: 14562805.

70: Roehrborn CG. Prevention of prostate cancer with finasteride. N Engl J Med. 2003 Oct 16;349(16):1569-72; author reply 1569-72. PubMed PMID: 14562804.

71: Barzell WE. Prevention of prostate cancer with finasteride. N Engl J Med. 2003 Oct 16;349(16):1569-72; author reply 1569-72. PubMed PMID: 14562803.

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73: Beer TM. Preventing prostate cancer. Finasteride shrinks enlarged prostates and may prevent some cases of prostate cancer. But it's no panacea. Health News. 2003 Aug;9(8):1-2. PubMed PMID: 12971313.

74: Thompson CA. Finasteride may prevent prostate cancer. Am J Health Syst Pharm. 2003 Aug 1;60(15):1511, 1515. PubMed PMID: 12951749.

75: Luo J, Dunn TA, Ewing CM, Walsh PC, Isaacs WB. Decreased gene expression of steroid 5 alpha-reductase 2 in human prostate cancer: implications for finasteride therapy of prostate carcinoma. Prostate. 2003 Oct 1;57(2):134-9. PubMed PMID: 12949937.

76: Stat bite: Estimated effect of finasteride on prostate cancer development. J Natl Cancer Inst. 2003 Jul 16;95(14):1031. PubMed PMID: 12865443.

77: Oh WK, Manola J, Bittmann L, Brufsky A, Kaplan ID, Smith MR, Kaufman DS, Kantoff PW. Finasteride and flutamide therapy in patients with advanced prostate cancer: response to subsequent castration and long-term follow-up. Urology. 2003 Jul;62(1):99-104. PubMed PMID: 12837431.

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83: Ornstein DK, Beiser JA, Andriole GL. Anaemia in men receiving combined finasteride and flutamide therapy for advanced prostate cancer. BJU Int. 1999 Jan;83(1):43-6. PubMed PMID: 10233450.

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85: Walsh PC. Treatment with finasteride preserves usefulness of prostate-specific antigen in the detection of prostate cancer: results of a randomized, double-blind, placebo-controlled clinical trial. J Urol. 1999 Jan;161(1):350-1. PubMed PMID: 10037436.

86: Ornstein DK, Smith DS, Andriole GL. Biochemical response to testicular androgen ablation among patients with prostate cancer for whom flutamide and/or finasteride therapy failed. Urology. 1998 Dec;52(6):1094-7. PubMed PMID: 9836561.

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91: Green L, Wysowski DK, Fourcroy JL. Gynecomastia and breast cancer during finasteride therapy. N Engl J Med. 1996 Sep 12;335(11):823. PubMed PMID: 8778596.

92: Gormley GJ, Brawley O, Thompson I. The potential application of finasteride for chemoprevention of prostate cancer. Ann N Y Acad Sci. 1995 Sep 30;768:163-9. Review. PubMed PMID: 8526345.

93: Andriole G, Lieber M, Smith J, Soloway M, Schroeder F, Kadmon D, DeKernion J, Rajfer J, Boake R, Crawford D, et al. Treatment with finasteride following radical prostatectomy for prostate cancer. Urology. 1995 Mar;45(3):491-7. PubMed PMID: 7533461.

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95: Thompson I, Feigl P, Coltman C. Chemoprevention of prostate cancer with finasteride. Important Adv Oncol. 1995:57-76. Review. PubMed PMID: 7672814.

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97: Fleshner NE, Trachtenberg J. Treatment of advanced prostate cancer with the combination of finasteride plus flutamide: early results. Eur Urol. 1993;24 Suppl 2:106-12. PubMed PMID: 7505229.

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