Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3407 participants
INTERVENTIONAL
1995-12-31
2001-11-30
Brief Summary
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MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Doxazosin and Finasteride placebos
Doxazosin placebo
Finasteride placebo
Doxazosin
Doxazosin and Finasteride placebo
Doxazosin
Finasteride placebo
Finasteride
Doxazosin placebo and Finasteride
Finasteride
Doxazosin placebo
Combination
Doxazosin and Finasteride
Doxazosin
Doxazosin placebo
Interventions
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Doxazosin
Finasteride
Doxazosin placebo
Finasteride placebo
Eligibility Criteria
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Inclusion Criteria
* American Urological Association Symptom Score is greater than or equal to 8 and less than or equal to 30.
* Voluntarily signed the informed consent agreement prior to the performance of any study procedures.
Exclusion Criteria
* Supine blood pressure less than 90/70 mmHG. Orthostatic hypotension.
* Any prior medical or surgical intervention for BPH.
* Received any prior experimental intervention (either medical or surgical) for prostate disease or enrolled in any other study protocol.
50 Years
MALE
Yes
Sponsors
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George Washington University
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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E. David Crawford
Role: PRINCIPAL_INVESTIGATOR
Clinic 01 - Univ of Colorado Health Sciences Center
Steven A. Kaplan
Role: PRINCIPAL_INVESTIGATOR
Clinic 02 - New York Presbyterian Hospital
Claus Roehrborn
Role: PRINCIPAL_INVESTIGATOR
Clinic 03 - UT Southwestern Medical Center
Noah S. Schenkman
Role: PRINCIPAL_INVESTIGATOR
Clinic 04 - Walter Reed Army Medical Center
Herbert Lepor
Role: PRINCIPAL_INVESTIGATOR
Clinic 06 - New York University School of Medicine
Kevin M. Slawin
Role: PRINCIPAL_INVESTIGATOR
Clinic 07 - Baylor College of Medicine
John P. Foley
Role: PRINCIPAL_INVESTIGATOR
Clinic 08 - Brooke Army Medical Center
Joe W. Ramsdell
Role: PRINCIPAL_INVESTIGATOR
Clinic 09 - University of California San Diego
Mani Menon
Role: PRINCIPAL_INVESTIGATOR
Clinic 10 - Henry Ford Hospital
Michael M. Lieber
Role: PRINCIPAL_INVESTIGATOR
Clinic 11 - Mayo Foundation
Kevin T. McVary
Role: PRINCIPAL_INVESTIGATOR
Clinic 12 - Northwestern University
Joseph A. Smith
Role: PRINCIPAL_INVESTIGATOR
Clinic 13 - Vanderbilt University
Gerald L. Andriole
Role: PRINCIPAL_INVESTIGATOR
Clinic 14 - Washington University
Harris E. Foster
Role: PRINCIPAL_INVESTIGATOR
Clinic 15 - Yale University
Harry S. Clarke
Role: PRINCIPAL_INVESTIGATOR
Clinic 16 - Emory University
Karl J. Kreder
Role: PRINCIPAL_INVESTIGATOR
Clinic 17 - University of Iowa
Stephen C. Jacobs
Role: PRINCIPAL_INVESTIGATOR
Clinic 18 - University of Maryland
Gary J. Miller
Role: PRINCIPAL_INVESTIGATOR
Diagnostic Center - Univ of Colorado Health Sciences Center
Oliver M. Bautista
Role: PRINCIPAL_INVESTIGATOR
Biostatistical Coordinating Center - George Washington Univ.
Locations
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University of California
La Jolla, California, United States
Univ of Colorado Health Sciences Center
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa Hospitals Clinics
Iowa City, Iowa, United States
University of Maryland
Baltimore, Maryland, United States
Henry Ford Health Systems
Detroit, Michigan, United States
Mayo Foundation
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
New York University School of Medicine
New York, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Vanderbilt University
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Countries
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References
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Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.
Sidney S, Quesenberry CP Jr, Sadler MC, Guess HA, Lydick EG, Cattolica EV. Incidence of surgically treated benign prostatic hypertrophy and of prostate cancer among blacks and whites in a prepaid health care plan. Am J Epidemiol. 1991 Oct 15;134(8):825-9. doi: 10.1093/oxfordjournals.aje.a116157.
Gormley GJ, Stoner E, Bruskewitz RC, Imperato-McGinley J, Walsh PC, McConnell JD, Andriole GL, Geller J, Bracken BR, Tenover JS, et al. The effect of finasteride in men with benign prostatic hyperplasia. The Finasteride Study Group. N Engl J Med. 1992 Oct 22;327(17):1185-91. doi: 10.1056/NEJM199210223271701.
Lepor H, Gup DI, Baumann M, Shapiro E. Laboratory assessment of terazosin and alpha-1 blockade in prostatic hyperplasia. Urology. 1988 Dec;32(6 Suppl):21-6.
Lepor H, Henry D, Laddu AR. The efficacy and safety of terazosin for the treatment of symptomatic BPH. Prostate. 1991;18(4):345-55. doi: 10.1002/pros.2990180408.
Guess HA. Benign prostatic hyperplasia: antecedents and natural history. Epidemiol Rev. 1992;14:131-53. doi: 10.1093/oxfordjournals.epirev.a036083. No abstract available.
McConnell JD. Androgen ablation and blockade in the treatment of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):661-70.
Barry MJ. Epidemiology and natural history of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):495-507.
Mebust WK, Holtgrewe HL, Cockett AT, Peters PC. Transurethral prostatectomy: immediate and postoperative complications. A cooperative study of 13 participating institutions evaluating 3,885 patients. J Urol. 1989 Feb;141(2):243-7. doi: 10.1016/s0022-5347(17)40731-2.
McConnell JD, Roehrborn CG, Bautista OM, Andriole GL Jr, Dixon CM, Kusek JW, Lepor H, McVary KT, Nyberg LM Jr, Clarke HS, Crawford ED, Diokno A, Foley JP, Foster HE, Jacobs SC, Kaplan SA, Kreder KJ, Lieber MM, Lucia MS, Miller GJ, Menon M, Milam DF, Ramsdell JW, Schenkman NS, Slawin KM, Smith JA; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003 Dec 18;349(25):2387-98. doi: 10.1056/NEJMoa030656.
Kusek JW, Ahrens A, Burrows PK, Clarke HS, Foster HE, Hanson K, Jacobs SC, Kirkemo A, O'Berry K, Pavlik VN; MTOPS Research Group. Recruitment for a clinical trial of drug treatment for benign prostatic hyperplasia. Urology. 2002 Jan;59(1):63-7. doi: 10.1016/s0090-4295(01)01454-6.
Bautista OM, Kusek JW, Nyberg LM, McConnell JD, Bain RP, Miller G, Crawford ED, Kaplan SA, Sihelnik SA, Brawer MK, Lepor H. Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial. Control Clin Trials. 2003 Apr;24(2):224-43. doi: 10.1016/s0197-2456(02)00263-5.
Long B, Cheema A, Copelan O, Joyce C, Feffer M, McVary KT. Five-Year Outcomes of Water Vapor Therapy vs Doxazosin, Finasteride, and Combination Therapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Cohort Data From the Medical Therapy of Prostatic Symptoms Trial. Urology. 2025 Jul 17:S0090-4295(25)00692-2. doi: 10.1016/j.urology.2025.07.016. Online ahead of print.
Related Links
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MTOPS public access site. Userid and password not required.
Other Identifiers
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MTOPS (completed)
Identifier Type: -
Identifier Source: org_study_id
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