Medical Therapy of Prostatic Symptoms (MTOPS)

• ClinicalTrials.gov Identifier: NCT00021814
• Recruitment Status: Completed
• First Posted: August 6, 2001
• Last Update Posted: September 28, 2018
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: George Washington University
• Information provided by (Responsible Party): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostatic Hyperplasia; Prostatic Hypertrophy, Benign	Drug: Doxazosin; Drug: Finasteride; Drug: Doxazosin placebo; Drug: Finasteride placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3407 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Medical Therapy of Prostatic Symptoms
• Actual Study Start Date: December 1995
• Actual Primary Completion Date: November 30, 2001
• Actual Study Completion Date: November 30, 2001

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Doxazosin and Finasteride placebos	Drug: Doxazosin placebo; Drug: Finasteride placebo
Experimental: Doxazosin; Doxazosin and Finasteride placebo	Drug: Doxazosin; Drug: Finasteride placebo
Experimental: Finasteride; Doxazosin placebo and Finasteride	Drug: Finasteride; Drug: Doxazosin placebo
Experimental: Combination; Doxazosin and Finasteride	Drug: Doxazosin; Drug: Doxazosin placebo

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, California

University of California

La Jolla, California, United States, 92093-0694

United States, Colorado

Univ of Colorado Health Sciences Center

Aurora, Colorado, United States, 80010-0510

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06520

United States, District of Columbia

Walter Reed Army Medical Center

Washington, District of Columbia, United States, 20307

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, Iowa

University of Iowa Hospitals Clinics

Iowa City, Iowa, United States, 52242

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

United States, Michigan

Henry Ford Health Systems

Detroit, Michigan, United States, 48202

United States, Minnesota

Mayo Foundation

Rochester, Minnesota, United States, 55905

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63141

United States, New York

New York University School of Medicine

New York, New York, United States, 10010

Columbia Presbyterian Medical Center

New York, New York, United States, 10032

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37232-2765

United States, Texas

UT Southwestern Medical Center

Dallas, Texas, United States, 5235-9110

Baylor College of Medicine

Houston, Texas, United States, 77005

Brooke Army Medical Center

San Antonio, Texas, United States, 78234-6200

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

George Washington University

Investigators

• Principal Investigator: 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.

More Information

Additional Information:

MTOPS public access site. Userid and password not required. 

Publications of Results:

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.

Other Publications:

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.

• Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• ClinicalTrials.gov Identifier: NCT00021814
• Other Study ID Numbers: MTOPS (completed); U01DK046472 ( U.S. NIH Grant/Contract )
• First Posted: August 6, 2001
• Last Update Posted: September 28, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data and specimens will be submitted to the NIDDK Central Repository
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: 2006
• URL: https://repository.niddk.nih.gov/studies/mtops/?query=mtops

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Hypertrophy; Pathologic Processes; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Doxazosin; Finasteride; 5-alpha Reductase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Urological Agents; Antihypertensive Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents