Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline.

PURPOSE To develop an evidence-based guideline on the use of 5-alpha-reductase inhibitors (5-ARIs) for prostate cancer chemoprevention. METHODS The American Society of Clinical Oncology (ASCO) Health Services Committee (HSC), ASCO Cancer Prevention Committee, and the American Urological Association Practice Guidelines Committee jointly convened a Panel of experts, who used the results from a systematic review of the literature to develop evidence-based recommendations on the use of 5-ARIs for prostate cancer chemoprevention. Results The systematic review completed for this guideline identified 15 randomized clinical trials that met the inclusion criteria, nine of which reported prostate cancer period prevalence. CONCLUSION Asymptomatic men with a prostate-specific antigen (PSA) <or= 3.0 ng/mL who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate cancer and the potential risks (including the possibility of high-grade prostate cancer). Men who are taking 5-ARIs for benign conditions such as lower urinary tract [obstructive] symptoms (LUTS) may benefit from a similar discussion, understanding that the improvement of LUTS relief should be weighed with the potential risks of high-grade prostate cancer from 5-ARIs (although the majority of the Panel members judged the latter risk to be unlikely). A reduction of approximately 50% in PSA by 12 months is expected in men taking a 5-ARI; however, because these changes in PSA may vary across men, and within individual men over time, the Panel cannot recommend a specific cut point to trigger a biopsy for men taking a 5-ARI. No specific cut point or change in PSA has been prospectively validated in men taking a 5-ARI.

[1]  I. Thompson,et al.  Pathologic Characteristics of Cancers Detected in the Prostate Cancer Prevention Trial: Implications for Prostate Cancer Detection and Chemoprevention , 2008, Cancer Prevention Research.

[2]  I. Thompson,et al.  Finasteride Does Not Increase the Risk of High-Grade Prostate Cancer: A Bias-Adjusted Modeling Approach , 2008, Cancer Prevention Research.

[3]  T. Wilt,et al.  Five-alpha-reductase Inhibitors for prostate cancer prevention. , 2008, The Cochrane database of systematic reviews.

[4]  P. Gann,et al.  Detection bias due to the effect of finasteride on prostate volume: a modeling approach for analysis of the Prostate Cancer Prevention Trial. , 2007, Journal of the National Cancer Institute.

[5]  M. Kattan,et al.  Finasteride and high-grade prostate cancer in the Prostate Cancer Prevention Trial. , 2007, Journal of the National Cancer Institute.

[6]  I. Thompson,et al.  Prediction of prostate cancer for patients receiving finasteride: results from the Prostate Cancer Prevention Trial. , 2007, Journal of Clinical Oncology.

[7]  I. Thompson,et al.  Longitudinal analysis of sexual function reported by men in the Prostate Cancer Prevention Trial. , 2007, Journal of the National Cancer Institute.

[8]  A. D'Amico,et al.  Effect of 1 mg/day finasteride on concentrations of serum prostate-specific antigen in men with androgenic alopecia: a randomised controlled trial. , 2007, The Lancet. Oncology.

[9]  Javier Hernandez,et al.  External validation of the Prostate Cancer Prevention Trial risk calculator in a screened population. , 2006, Urology.

[10]  I. Thompson,et al.  Effect of finasteride on the sensitivity of PSA for detecting prostate cancer. , 2006, Journal of the National Cancer Institute.

[11]  C. Roehrborn,et al.  The Cost of Prostate Cancer Chemoprevention: A Decision Analysis Model , 2006, Cancer Epidemiology Biomarkers & Prevention.

[12]  Norman Wolmark,et al.  Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. , 2006, JAMA.

[13]  D. Alberts,et al.  The role of prevention in oncology practice: results from a 2004 survey of American Society of Clinical Oncology members. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[14]  Ziding Feng,et al.  Assessing prostate cancer risk: results from the Prostate Cancer Prevention Trial. , 2006, Journal of the National Cancer Institute.

[15]  C. Roehrborn,et al.  Combination Therapy With Doxazosin and Finasteride for Benign Prostatic Hyperplasia in Patients With Lower Urinary Tract Symptoms and a Baseline Total Prostate Volume of 25 Ml or Greater , 2006 .

[16]  L. Ford,et al.  Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. , 2005, Journal of the National Cancer Institute.

[17]  J. Talcott Rebalancing ratios and improving impressions: later thoughts from the prostate cancer prevention trial investigators. , 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[18]  I. Thompson,et al.  Assessing benefit and risk in the prevention of prostate cancer: the prostate cancer prevention trial revisited. , 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[19]  Ruth Etzioni,et al.  Lifetime implications and cost-effectiveness of using finasteride to prevent prostate cancer. , 2005, The American journal of medicine.

[20]  D. Penson,et al.  The relationship among lower urinary tract symptoms, prostate specific antigen and erectile dysfunction in men with benign prostatic hyperplasia: results from the proscar long-term efficacy and safety study. , 2005, The Journal of urology.

[21]  B. Kramer,et al.  Cancer prevention and the American Society of Clinical Oncology. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[22]  D. Tindall,et al.  Chemoprevention of prostate cancer in men at high risk: rationale and design of the reduction by dutasteride of prostate cancer events (REDUCE) trial. , 2004, The Journal of urology.

[23]  G. Andriole,et al.  Effect of dutasteride on the detection of prostate cancer in men with benign prostatic hyperplasia. , 2004, Urology.

[24]  G. Cunningham,et al.  Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor. , 2004, The Journal of clinical endocrinology and metabolism.

[25]  H. Gilbert Welch,et al.  Should I Be Tested for Cancer?: Maybe Not and Here's Why , 2004 .

[26]  C. Roehrborn,et al.  The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. , 2003, The New England journal of medicine.

[27]  P. Rigatti,et al.  A comparison of the efficacy and tolerability of tamsulosin and finasteride in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia , 2003, Prostate Cancer and Prostatic Diseases.

[28]  P. Boyle,et al.  Improvements in benign prostatic hyperplasia‐specific quality of life with dutasteride, the novel dual 5α‐reductase inhibitor , 2003, BJU international.

[29]  Michael M Lieber,et al.  The influence of finasteride on the development of prostate cancer. , 2003, The New England journal of medicine.

[30]  A. Zuger A big study yields big questions. , 2003, The New England journal of medicine.

[31]  G. Andriole,et al.  Safety and Tolerability of the Dual 5α-Reductase Inhibitor Dutasteride in the Treatment of Benign Prostatic Hyperplasia , 2003 .

[32]  M. Kutner,et al.  Changes in nocturia from medical treatment of benign prostatic hyperplasia: secondary analysis of the Department of Veterans Affairs Cooperative Study Trial. , 2003, The Journal of urology.

[33]  J. Waldstreicher,et al.  Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia. , 2003, Urology.

[34]  R. J. Cersosimo Tamoxifen for Prevention of Breast Cancer , 2003, The Annals of pharmacotherapy.

[35]  P. Boyle,et al.  Efficacy and tolerability of doxazosin and finasteride, alone or in combination, in treatment of symptomatic benign prostatic hyperplasia: the Prospective European Doxazosin and Combination Therapy (PREDICT) trial. , 2003, Urology.

[36]  E. Lee Comparison of Tamsulosin and Finasteride for Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia in Korean Patients , 2002, The Journal of international medical research.

[37]  P. Boyle,et al.  Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. , 2002, Urology.

[38]  S. Kaplan,et al.  Impact of baseline symptom severity on future risk of benign prostatic hyperplasia-related outcomes and long-term response to finasteride. The Pless Study Group. , 2000, Urology.

[39]  D. Summerton,et al.  A prospective study of the natural history of hematuria associated with benign prostatic hyperplasia and the effect of finasteride. , 2000, The Journal of urology.

[40]  B. Fisher Tamoxifen for prevention of breast cancer. , 1999, The Medical letter on drugs and therapeutics.

[41]  C K Redmond,et al.  Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. , 1999, Journal of the National Cancer Institute.

[42]  E. Crawford,et al.  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. PLESS Study Group. Proscar Long-term Efficacy and Safety Study. , 1998, Urology.

[43]  M. Pike,et al.  The effect of finasteride on the prostate gland in men with elevated serum prostate-specific antigen levels. , 1998, British Journal of Cancer.

[44]  C. Roehrborn,et al.  The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia , 1998 .

[45]  M. Elhilali,et al.  Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study. , 1996, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[46]  H. Lepor,et al.  The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. , 1996, The New England journal of medicine.

[47]  E. Round,et al.  CLINICAL-EXPERIENCE OF THE DETECTION OF PROSTATE-CANCER IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA TREATED WITH FINASTERIDE , 1994 .

[48]  E. Stoner,et al.  Three-year safety and efficacy data on the use of finasteride in the treatment of benign prostatic hyperplasia. , 1994, Urology.

[49]  E. Stoner Maintenance of clinical efficacy with finasteride therapy for 24 months in patients with benign prostatic hyperplasia. The Finasteride Study Group. , 1994, Archives of internal medicine.

[50]  G. Andriole,et al.  The effect of finasteride in men with benign prostatic hyperplasia. , 1992, The Journal of urology.

[51]  R. Chlebowski,et al.  Current attitudes and practice of American Society of Clinical Oncology-member clinical oncologists regarding cancer prevention and control. , 1992, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.