Medical Therapy of Prostatic Symptoms (MTOPS)
Overview[ - collapse ][ - ]
| Purpose | 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 | Prostatic Hyperplasia Prostatic Hypertrophy, Benign |
| Intervention | Drug: Doxazosin Drug: Finasteride |
| Phase | Phase 3 |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Responsible Party | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier | NCT00021814 |
| First Received | August 4, 2001 |
| Last Updated | January 12, 2010 |
| Last verified | January 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 4, 2001 |
|---|---|
| Last Updated Date | January 12, 2010 |
| Start Date | December 1995 |
| Estimated Primary Completion Date | March 1998 |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Medical Therapy of Prostatic Symptoms (MTOPS) |
|---|---|
| Official Title | Not Provided |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: Doxazosin Drug: Finasteride |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 2931 |
| Estimated Completion Date | March 1998 |
| Estimated Primary Completion Date | Not Provided |
| 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. |
| Gender | Male |
| Ages | 50 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00021814 |
|---|---|
| Other Study ID Numbers | MTOPS (completed) |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Study Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: E. David Crawford Clinic 01 - Univ of Colorado Health Sciences CenterPrincipal Investigator: Steven A. Kaplan Clinic 02 - New York Presbyterian HospitalPrincipal Investigator: Claus Roehrborn Clinic 03 - UT Southwestern Medical CenterPrincipal Investigator: Noah S. Schenkman Clinic 04 - Walter Reed Army Medical CenterPrincipal Investigator: Herbert Lepor Clinic 06 - New York University School of MedicinePrincipal Investigator: Kevin M. Slawin Clinic 07 - Baylor College of MedicinePrincipal Investigator: John P. Foley Clinic 08 - Brooke Army Medical CenterPrincipal Investigator: Joe W. Ramsdell Clinic 09 - University of California San DiegoPrincipal Investigator: Mani Menon Clinic 10 - Henry Ford HospitalPrincipal Investigator: Michael M. Lieber Clinic 11 - Mayo FoundationPrincipal Investigator: Kevin T. McVary Clinic 12 - Northwestern UniversityPrincipal Investigator: Joseph A. Smith Clinic 13 - Vanderbilt UniversityPrincipal Investigator: Gerald L. Andriole Clinic 14 - Washington UniversityPrincipal Investigator: Harris E. Foster Clinic 15 - Yale UniversityPrincipal Investigator: Harry S. Clarke Clinic 16 - Emory UniversityPrincipal Investigator: Karl J. Kreder Clinic 17 - University of IowaPrincipal Investigator: Stephen C. Jacobs Clinic 18 - University of MarylandPrincipal Investigator: Gary J. Miller Diagnostic Center - Univ of Colorado Health Sciences CenterPrincipal Investigator: Oliver M. Bautista Biostatistical Coordinating Center - George Washington Univ. |
| Verification Date | January 2010 |
Locations[ + expand ][ + ]
| University of California | La Jolla, California, United States, 92093-0694 |
|---|---|
| Univ of Colorado Health Sciences Center | Aurora, Colorado, United States, 80010-0510 |
| Yale University | New Haven, Connecticut, United States, 06520 |
| Walter Reed Army Medical Center | Washington, District of Columbia, United States, 20307 |
| Emory University | Atlanta, Georgia, United States, 30322 |
| Northwestern University | Chicago, Illinois, United States, 60611 |
| University of Iowa Hospitals Clinics | Iowa City, Iowa, United States, 52242 |
| University of Maryland | Baltimore, Maryland, United States, 21201 |
| Henry Ford Health Systems | Detroit, Michigan, United States, 48202 |
| Mayo Foundation | Rochester, Minnesota, United States, 55905 |
| Washington University | St. Louis, Missouri, United States, 63141 |
| Columbia Presbyterian Medical Center | New York, New York, United States, 10032 |
| New York University School of Medicine | New York, New York, United States, 10010 |
| Vanderbilt University | Nashville, Tennessee, United States, 37232-2765 |
| 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 |