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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Finasteride (Proscar) for the Chemoprevention of Prostate Cancer
Alternate Title Finasteride in Preventing the Recurrence of Prostate Cancer
Objectives I. Determine the efficacy (i.e., decrease in tumor initiation, promotion, or progression rate) of long-term (7-year) treatment with finasteride (Proscar, MK-906) in reducing the incidence of prostate cancer in men aged 55 and older. II. Assess the effect of MK-906 on the stage and grade of prostate cancer at time of diagnosis. III. Assess the toxicity and side effects of MK-906 administered on this schedule. IV. Estimate total mortality and prostate cancer-specific mortality in men treated with MK-906 versus placebo. V. Estimate the incidence and severity of benign prostatic hyperplasia in men treated with MK-906 versus placebo. VI. Estimate the sensitivity, specificity, and predictive values of digital rectal examination (DRE), prostate-specific antigen (PSA), and PSA plus DRE as screening tests for the detection of prostate cancer and determine the effect of long-term treatment with MK-906 on these screening parameters. VII. Assess the effect of long-term treatment with MK-906 on participants' self-report of urinary and sexual function symptoms and other quality-of-life dimensions. Entry Criteria Disease Characteristics: See General Eligibility Criteria Prior/Concurrent Therapy: No concurrent participation in any other clinical trial Biologic therapy: Not specified Chemotherapy: No prior finasteride (Proscar) No prior chemotherapy for cancer Endocrine therapy: No prior anabolic steroids No prior hormonal therapy for cancer Radiotherapy: No prior radiotherapy for cancer Surgery: At least 6 months since transurethral resection of the prostate Patient Characteristics: Age: 55 and older Performance status: SWOG 0 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No MI within 3 months No active angina No unstable heart rhythm No clinically evident CHF Other: No requirement for anticoagulation therapy (e.g., coumadin) Aspirin taken as anticoagulation therapy allowed No uncontrolled diabetes No uncontrolled peptic ulcer disease No HIV positivity No other medical illness unless adequately controlled by appropriate therapy No prior malignancy within 5 years except nonmelanomatous skin cancer Barrier contraception required Willing to complete quality-of-life assessments, as required Able and willing to participate in full 7-year study Blood/body fluid analyses to determine eligibility and imaging studies and physical exams for tumor measurement completed within 14 days prior to registration; screening exams (other than blood/body fluid analyses) and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration General Eligibility Criteria: Additional referral information for this trial is available from CancerFax (dial 301-402-5874 from the telephone on your fax machine) and from the Cancer Information Service (1-800-422-6237) --Population Characteristics-- Men of such an age (55 or older) and medical condition that a physician would anticipate treatment should they be diagnosed with prostate cancer within 7 years Individuals of an advanced age or anticipated medical status such that prostate cancer diagnosed on study would not require treatment are ineligible Normal DRE, without induration, asymmetry, or prostate nodularity, required within 28 days prior to entry PSA no greater than 3.0 ng/ml on monoclonal assay performed by the Central Laboratory Facility within 28 days prior to entry No prior diagnosis of prostate cancer No urinary retention No need for immediate medical or surgical treatment of urinary obstructive symptoms No severe prostatism as manifested by an AUA symptom score of 20 or more --Prior/Concurrent Therapy-- No concurrent participation in any other clinical trial Biologic therapy: Not specified Chemotherapy: No prior finasteride (Proscar) No prior chemotherapy for cancer Endocrine therapy: No prior anabolic steroids No prior hormonal therapy for cancer Radiotherapy: No prior radiotherapy for cancer Surgery: At least 6 months since transurethral resection of the prostate --Patient Characteristics-- Age: 55 and older Performance status: SWOG 0 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No MI within 3 months No active angina No unstable heart rhythm No clinically evident CHF Other: No requirement for anticoagulation therapy (e.g., coumadin) Aspirin taken as anticoagulation therapy allowed No uncontrolled diabetes No uncontrolled peptic ulcer disease No HIV positivity No other medical illness unless adequately controlled by appropriate therapy No prior malignancy within 5 years except nonmelanomatous skin cancer Barrier contraception required Willing to complete quality-of-life assessments, as required Able and willing to participate in full 7-year study Blood/body fluid analyses to determine eligibility and imaging studies and physical exams for tumor measurement completed within 14 days prior to registration; screening exams (other than blood/body fluid analyses) and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration Expected Enrollment 18,000 subjects will be randomized (9,000/arm) over 3 years. Outline Randomized, double-blind, placebo-controlled study. Arm I: Chemoprevention. Finasteride, Proscar, MK-906. Arm II: Control. Placebo, PLCB.Published Results Hoque A, Goodman P, Ambrosone CB, et al.: Extraction of DNA from serum for high-throughput genotyping: findings from pilot studies within the Prostate Cancer Prevention Trial. Urology 71 (5): 967-70, 2008.[PUBMED Abstract] Kristal AR, Arnold KB, Schenk JM, et al.: Dietary patterns, supplement use, and the risk of symptomatic benign prostatic hyperplasia: results from the prostate cancer prevention trial. Am J Epidemiol 167 (8): 925-34, 2008.[PUBMED Abstract] Song Y, Tangen C, Goodman P, et al.: Finasteride, prostate cancer, and weight gain: evidence for genetic or environmental factors that affect cancer outcomes during finasteride treatment. Prostate 68 (3): 281-6, 2008.[PUBMED Abstract] Cohen YC, Liu KS, Heyden NL, et al.: 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 99 (18): 1366-74, 2007.[PUBMED Abstract] Kristal AR, Arnold KB, Schenk JM, et al.: Race/ethnicity, obesity, health related behaviors and the risk of symptomatic benign prostatic hyperplasia: results from the prostate cancer prevention trial. J Urol 177 (4): 1395-400; quiz 1591, 2007.[PUBMED Abstract] Lucia MS, Epstein JI, Goodman PJ, et al.: Finasteride and high-grade prostate cancer in the Prostate Cancer Prevention Trial. J Natl Cancer Inst 99 (18): 1375-83, 2007.[PUBMED Abstract] Moinpour CM, Darke AK, Donaldson GW, et al.: Longitudinal analysis of sexual function reported by men in the Prostate Cancer Prevention Trial. J Natl Cancer Inst 99 (13): 1025-35, 2007.[PUBMED Abstract] Thompson IM, Lucia MS, Redman MW, et al.: Finasteride decreases the risk of prostatic intraepithelial neoplasia. J Urol 178 (1): 107-9; discussion 110, 2007.[PUBMED Abstract] Thompson IM, Pauler Ankerst D, Chi C, et al.: Prediction of prostate cancer for patients receiving finasteride: results from the Prostate Cancer Prevention Trial. J Clin Oncol 25 (21): 3076-81, 2007.[PUBMED Abstract] Thompson IM, Tangen CM, Goodman PJ, et al.: Finasteride improves the sensitivity of digital rectal examination for prostate cancer detection. J Urol 177 (5): 1749-52, 2007.[PUBMED Abstract] Goodman PJ, Thompson IM Jr, Tangen CM, et al.: The prostate cancer prevention trial: design, biases and interpretation of study results. J Urol 175 (6): 2234-42, 2006.[PUBMED Abstract] Thompson IM, Ankerst DP, Chi C, et al.: Assessing prostate cancer risk: results from the Prostate Cancer Prevention Trial. J Natl Cancer Inst 98 (8): 529-34, 2006.[PUBMED Abstract] Thompson IM, Chi C, Ankerst DP, et al.: Effect of finasteride on the sensitivity of PSA for detecting prostate cancer. J Natl Cancer Inst 98 (16): 1128-33, 2006.[PUBMED Abstract] Etzioni RD, Howlader N, Shaw PA, et al.: Long-term effects of finasteride on prostate specific antigen levels: results from the prostate cancer prevention trial. J Urol 174 (3): 877-81, 2005.[PUBMED Abstract] Thompson IM, Ankerst DP, Chi C, et al.: Operating characteristics of prostate-specific antigen in men with an initial PSA level of 3.0 ng/ml or lower. JAMA 294 (1): 66-70, 2005.[PUBMED Abstract] Thompson IM, Pauler DK, Goodman PJ, et al.: Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter. N Engl J Med 350 (22): 2239-46, 2004.[PUBMED Abstract] Thompson IM, Goodman PJ, Tangen CM, et al.: The influence of finasteride on the development of prostate cancer. N Engl J Med 349 (3): 215-24, 2003.[PUBMED Abstract] Pauler DK, Gower KB, Goodman PJ, et al.: Biomarker-based methods for determining noncompliance in a prevention trial. Control Clin Trials 23 (6): 675-85, 2002.[PUBMED Abstract] Satia-Abouta J, Patterson RE, Schiller RN, et al.: Energy from fat is associated with obesity in U.S. men: results from the Prostate Cancer Prevention Trial. Prev Med 34 (5): 493-501, 2002.[PUBMED Abstract] Neuhouser ML, Kristal AR, Patterson RE, et al.: Dietary supplement use in the Prostate Cancer Prevention Trial: implications for prevention trials. Nutr Cancer 39 (1): 12-8, 2001.[PUBMED Abstract] Ryan AM, Goodman P, Hill S, et al.: Promoting adherence to the prostate cancer prevention trial end of study biopsy requirement. [Abstract] Control Clin Trials 22 (suppl 2): A-P71, 88S, 2001. Thompson IM Jr, Kouril M, Klein EA, et al.: The Prostate Cancer Prevention Trial: Current status and lessons learned. Urology 57 (4 Suppl 1): 230-4, 2001.[PUBMED Abstract] Moinpour CM, Lovato LC, Thompson IM Jr, et al.: Profile of men randomized to the prostate cancer prevention trial: baseline health-related quality of life, urinary and sexual functioning, and health behaviors. J Clin Oncol 18 (9): 1942-53, 2000.[PUBMED Abstract] Neuhouser ML, Kristal AR, Patterson RE, et al.: Dietary supplement use in the prostate cancer prevention trial: implications for the study findings. [Abstract] Proceedings of the American Society of Prevention Oncology A76, 2000. Coltman CA Jr, Thompson IM Jr, Feigl P: Prostate Cancer Prevention Trial (PCPT) update. Eur Urol 35 (5-6): 544-7, 1999.[PUBMED Abstract] Neuhouser ML, Kristal AR, McLerran D, et al.: Validity of short food frequency questionnaires used in cancer chemoprevention trials: results from the Prostate Cancer Prevention Trial. Cancer Epidemiol Biomarkers Prev 8 (8): 721-5, 1999.[PUBMED Abstract] Goodman PJ, Lovato L, Ryan A, et al.: Utility of the enrollment period in the prostate cancer prevention trial (PCPT). [Abstract] Control Clin Trials 18 (3 suppl): A-19, 52S, 1997. Thompson IM, Coltman CA Jr, Crowley J: Chemoprevention of prostate cancer: the Prostate Cancer Prevention Trial. Prostate 33 (3): 217-21, 1997.[PUBMED Abstract] Coltman CA Jr, Feigl P, Thompson IM: Chemoprevention of prostate cancer with finasteride: an intergroup trial. [Abstract] Cancer Invest 13 (suppl 1): A-36, 43, 1995. Thompson IM, Coltman CA, Brawley OW, et al.: Chemoprevention of prostate cancer. Semin Urol 13(2): 122-129, 1995. Related PublicationsPepe MS, Feng Z, Huang Y, et al.: Integrating the predictiveness of a marker with its performance as a classifier. Am J Epidemiol 167 (3): 362-8, 2008.[PUBMED Abstract] Etzioni RD, Ankerst DP, Weiss NS, et al.: Is prostate-specific antigen velocity useful in early detection of prostate cancer? A critical appraisal of the evidence. J Natl Cancer Inst 99 (20): 1510-5, 2007.[PUBMED Abstract] Smith JA: Estimated impact of the Prostate Cancer Prevention Trial on population mortality[commentary]. Urol Oncol 23 (6): 463, 2005. Unger JM, Thompson IM Jr, LeBlanc M, et al.: Estimated impact of the Prostate Cancer Prevention Trial on population mortality. Cancer 103 (7): 1375-80, 2005.[PUBMED Abstract] Thompson IM, Tangen C, Goodman P: The Prostate Cancer Prevention Trial: design, status, and promise. World J Urol 21 (1): 28-30, 2003.[PUBMED Abstract] Chung TD, Park II, Ignacio L, et al.: Television and news print media are effective in recruiting potential participants in a prostate cancer chemoprevention trial. Int J Cancer 90 (5): 302-4, 2000.[PUBMED Abstract] Moinpour CM, Atkinson JO, Thomas SM, et al.: Minority recruitment in the prostate cancer prevention trial. Ann Epidemiol 10 (8 Suppl): S85-91, 2000.[PUBMED Abstract] Thompson IM, Coltman CA: Re: re: chemoprevention of urological cancer. J Urol 164 (4): 1321-2, 2000.[PUBMED Abstract] Coltman CA: The effect of finasteride on the prostate gland in men with elevated serum prostate-specific antigen level. Br J Cancer 81 (1): 184-5, 1999.[PUBMED Abstract] Allerton J, Seay T, Optenberg S, et al.: Army and Air Force leadership in the Prostate Cancer Prevention Trial. Urology 51 (4A Suppl): 64-6, 1998.[PUBMED Abstract] Ryan AM, Emel L, Goodman P: Data operations management and clinical datafax: the prostate cancer prevention trial (PCPT) experience. [Abstract] Control Clin Trials 18 (3 suppl): A- P74, 156S, 1997. Thompson IM, Coltman CA: Screening for prostate cancer: opportunities for prevention. Semin Urol Oncol 14 (2 Suppl 2): 4-10; discussion 10-1, 1996.[PUBMED Abstract] Feigl P, Blumenstein B, Thompson I, et al.: Design of the Prostate Cancer Prevention Trial (PCPT). Control Clin Trials 16 (3): 150-63, 1995.[PUBMED Abstract] Thompson I, Feigl P, Coltman C: Chemoprevention of prostate cancer with finasteride. Important Adv Oncol : 57-76, 1995.[PUBMED Abstract] Greco KE, Kulawiak L: Prostate cancer prevention: risk reduction through life-style, diet, and chemoprevention. Oncol Nurs Forum 21 (9): 1504-11, 1994.[PUBMED Abstract] Trial Lead Organizations Southwest Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. ![]() |
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