Medical Therapy of Prostatic Symptoms

NCT00021814 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: MTOPS (completed)U01DK046472
• Study Type: interventional
• Target: 3,407
• Locations: 1 country
• Sites: 17

Brief Summary

The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH). 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.

Conditions

Prostatic Hyperplasia; Prostatic Hypertrophy, Benign

Keywords

BPH progression; Medical Therapy; Finasteride; Doxazosin; Randomized; Multi-center; Clinical Trial; Proscar; Cardura

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Doxazosin and Finasteride placebos

Drug: Doxazosin placebo; Drug: Finasteride placebo

Doxazosin

EXPERIMENTAL

Doxazosin and Finasteride placebo

Drug: Doxazosin; Drug: Finasteride placebo

Finasteride

EXPERIMENTAL

Doxazosin placebo and Finasteride

Drug: Finasteride; Drug: Doxazosin placebo

Combination

EXPERIMENTAL

Doxazosin and Finasteride

Drug: Doxazosin; Drug: Doxazosin placebo

Interventions

Doxazosin DRUG

Combination; Doxazosin

Finasteride DRUG

Finasteride

Doxazosin placebo DRUG

Combination; Finasteride; Placebo

Finasteride placebo DRUG

Doxazosin; Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peak urinary flow rate at least 4 ml/sec but not greater than 15 ml/sec; and voided volume is at least 125 ml.
• 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.

You may not qualify if:

• Serum prostate specific antigen level greater than 10 ng/ml.
• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• George Washington University: collaborator

Study Sites (17)

University of California

La Jolla, California, 92093-0694, United States

Location

Univ of Colorado Health Sciences Center

Aurora, Colorado, 80010-0510, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa Hospitals Clinics

Iowa City, Iowa, 52242, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Mayo Foundation

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63141, United States

Location

New York University School of Medicine

New York, New York, 10010, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-2765, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 5235-9110, United States

Location

Baylor College of Medicine

Houston, Texas, 77005, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234-6200, United States

Location

Related Publications (13)

• 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.

  PMID: 6206240 BACKGROUND

• 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.

  PMID: 1719806 BACKGROUND

• 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.

  PMID: 1383816 BACKGROUND

• 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.

  PMID: 2462301 BACKGROUND

• 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.

  PMID: 1711689 BACKGROUND

• Guess HA. Benign prostatic hyperplasia: antecedents and natural history. Epidemiol Rev. 1992;14:131-53. doi: 10.1093/oxfordjournals.epirev.a036083. No abstract available.

  PMID: 1283852 BACKGROUND

• McConnell JD. Androgen ablation and blockade in the treatment of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):661-70.

  PMID: 1695786 BACKGROUND

• Barry MJ. Epidemiology and natural history of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):495-507.

  PMID: 1695778 BACKGROUND

• 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.

  PMID: 2643719 BACKGROUND

• 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.

  PMID: 14681504 RESULT

• 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.

  PMID: 11796283 RESULT

• 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.

  PMID: 12689743 RESULT

• 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 Dec;206:142-149. doi: 10.1016/j.urology.2025.07.016. Epub 2025 Jul 17.

  PMID: 40683564 DERIVED

Related Links

• MTOPS public access site. Userid and password not required.

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Doxazosin; Finasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• E. David Crawford

  Clinic 01 - Univ of Colorado Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Steven A. Kaplan

  Clinic 02 - New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

• Claus Roehrborn

  Clinic 03 - UT Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Noah S. Schenkman

  Clinic 04 - Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

• Herbert Lepor

  Clinic 06 - New York University School of Medicine

  PRINCIPAL INVESTIGATOR

• Kevin M. Slawin

  Clinic 07 - Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• John P. Foley

  Clinic 08 - Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

• Joe W. Ramsdell

  Clinic 09 - University of California San Diego

  PRINCIPAL INVESTIGATOR

• Mani Menon

  Clinic 10 - Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

• Michael M. Lieber

  Clinic 11 - Mayo Foundation

  PRINCIPAL INVESTIGATOR

• Kevin T. McVary

  Clinic 12 - Northwestern University

  PRINCIPAL INVESTIGATOR

• Joseph A. Smith

  Clinic 13 - Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Gerald L. Andriole

  Clinic 14 - Washington University

  PRINCIPAL INVESTIGATOR

• Harris E. Foster

  Clinic 15 - Yale University

  PRINCIPAL INVESTIGATOR

• Harry S. Clarke

  Clinic 16 - Emory University

  PRINCIPAL INVESTIGATOR

• Karl J. Kreder

  Clinic 17 - University of Iowa

  PRINCIPAL INVESTIGATOR

• Stephen C. Jacobs

  Clinic 18 - University of Maryland

  PRINCIPAL INVESTIGATOR

• Gary J. Miller

  Diagnostic Center - Univ of Colorado Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Oliver M. Bautista

  Biostatistical Coordinating Center - George Washington Univ.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2001
• First Posted: August 6, 2001
• Study Start: December 1, 1995
• Primary Completion: November 30, 2001
• Study Completion: November 30, 2001
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 2006

Locations

US (17)