Back to resultsMedical Therapy of Prostatic Symptoms (MTOPS)
Primary Purpose
Prostatic Hyperplasia, Prostatic Hypertrophy, Benign
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Doxazosin
Finasteride
Doxazosin placebo
Finasteride placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring BPH progression, Medical Therapy, Finasteride, Doxazosin, Randomized, Multi-center, Clinical Trial, Proscar, Cardura
Eligibility 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.
Sites / Locations
- University of California
- Univ of Colorado Health Sciences Center
- Yale University
- Walter Reed Army Medical Center
- Emory University
- Northwestern University
- University of Iowa Hospitals Clinics
- University of Maryland
- Henry Ford Health Systems
- Mayo Foundation
- Washington University
- New York University School of Medicine
- Columbia Presbyterian Medical Center
- Vanderbilt University
- UT Southwestern Medical Center
- Baylor College of Medicine
- Brooke Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Doxazosin
Finasteride
Combination
Arm Description
Doxazosin and Finasteride placebos
Doxazosin and Finasteride placebo
Doxazosin placebo and Finasteride
Doxazosin and Finasteride
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00021814
First Posted
August 4, 2001
Last Updated
September 26, 2018
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
George Washington University
1. Study Identification
Unique Protocol Identification Number
NCT00021814
Brief Title
Medical Therapy of Prostatic Symptoms
Acronym
MTOPS
Official Title
Medical Therapy of Prostatic Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 1995 (Actual)
Primary Completion Date
November 30, 2001 (Actual)
Study Completion Date
November 30, 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
George Washington University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Prostatic Hypertrophy, Benign
Keywords
BPH progression, Medical Therapy, Finasteride, Doxazosin, Randomized, Multi-center, Clinical Trial, Proscar, Cardura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3407 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Doxazosin and Finasteride placebos
Arm Title
Doxazosin
Arm Type
Experimental
Arm Description
Doxazosin and Finasteride placebo
Arm Title
Finasteride
Arm Type
Experimental
Arm Description
Doxazosin placebo and Finasteride
Arm Title
Combination
Arm Type
Experimental
Arm Description
Doxazosin and Finasteride
Intervention Type
Drug
Intervention Name(s)
Doxazosin
Intervention Type
Drug
Intervention Name(s)
Finasteride
Intervention Type
Drug
Intervention Name(s)
Doxazosin placebo
Intervention Type
Drug
Intervention Name(s)
Finasteride placebo
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. David Crawford
Organizational Affiliation
Clinic 01 - Univ of Colorado Health Sciences Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven A. Kaplan
Organizational Affiliation
Clinic 02 - New York Presbyterian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claus Roehrborn
Organizational Affiliation
Clinic 03 - UT Southwestern Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noah S. Schenkman
Organizational Affiliation
Clinic 04 - Walter Reed Army Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Herbert Lepor
Organizational Affiliation
Clinic 06 - New York University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin M. Slawin
Organizational Affiliation
Clinic 07 - Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John P. Foley
Organizational Affiliation
Clinic 08 - Brooke Army Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joe W. Ramsdell
Organizational Affiliation
Clinic 09 - University of California San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mani Menon
Organizational Affiliation
Clinic 10 - Henry Ford Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael M. Lieber
Organizational Affiliation
Clinic 11 - Mayo Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin T. McVary
Organizational Affiliation
Clinic 12 - Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph A. Smith
Organizational Affiliation
Clinic 13 - Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerald L. Andriole
Organizational Affiliation
Clinic 14 - Washington University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harris E. Foster
Organizational Affiliation
Clinic 15 - Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harry S. Clarke
Organizational Affiliation
Clinic 16 - Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl J. Kreder
Organizational Affiliation
Clinic 17 - University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen C. Jacobs
Organizational Affiliation
Clinic 18 - University of Maryland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary J. Miller
Organizational Affiliation
Diagnostic Center - Univ of Colorado Health Sciences Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oliver M. Bautista
Organizational Affiliation
Biostatistical Coordinating Center - George Washington Univ.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0694
Country
United States
Facility Name
Univ of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010-0510
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa Hospitals Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Henry Ford Health Systems
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Foundation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2765
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
5235-9110
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234-6200
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and specimens will be submitted to the NIDDK Central Repository
IPD Sharing Time Frame
2006
IPD Sharing URL
https://repository.niddk.nih.gov/studies/mtops/?query=mtops
Citations:
PubMed Identifier
6206240
Citation
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.
Results Reference
background
PubMed Identifier
1719806
Citation
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.
Results Reference
background
PubMed Identifier
1383816
Citation
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.
Results Reference
background
PubMed Identifier
2462301
Citation
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.
Results Reference
background
PubMed Identifier
1711689
Citation
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.
Results Reference
background
PubMed Identifier
1283852
Citation
Guess HA. Benign prostatic hyperplasia: antecedents and natural history. Epidemiol Rev. 1992;14:131-53. doi: 10.1093/oxfordjournals.epirev.a036083. No abstract available.
Results Reference
background
PubMed Identifier
1695786
Citation
McConnell JD. Androgen ablation and blockade in the treatment of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):661-70.
Results Reference
background
PubMed Identifier
1695778
Citation
Barry MJ. Epidemiology and natural history of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):495-507.
Results Reference
background
PubMed Identifier
2643719
Citation
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.
Results Reference
background
PubMed Identifier
14681504
Citation
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.
Results Reference
result
PubMed Identifier
11796283
Citation
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.
Results Reference
result
PubMed Identifier
12689743
Citation
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.
Results Reference
result
Links:
URL
http://www.bsc.gwu.edu/mtops/index.html
Description
MTOPS public access site. Userid and password not required.
Learn more about this trial
Medical Therapy of Prostatic Symptoms
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