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NCT00021814 Clinical Trial

Medical Therapy of Prostatic Symptoms

Prostatic Hyperplasia Clinical Trial

— MTOPS  

Official title:
Medical Therapy of Prostatic Symptoms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00021814
Other study ID # MTOPS (completed)
Secondary ID U01DK046472
Status Completed
Phase Phase 3
First received
Last updated
Start date December 1995
Est. completion date November 30, 2001

Study information
Verified date September 2018
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 3407
Est. completion date November 30, 2001
Est. primary completion date November 30, 2001
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Doxazosin

• Finasteride

• Doxazosin placebo

• Finasteride placebo

Locations
Country Name City State
United States Emory University Atlanta Georgia
United States Univ of Colorado Health Sciences Center Aurora Colorado
United States University of Maryland Baltimore Maryland
United States Northwestern University Chicago Illinois
United States UT Southwestern Medical Center Dallas Texas
United States Henry Ford Health Systems Detroit Michigan
United States Baylor College of Medicine Houston Texas
United States University of Iowa Hospitals Clinics Iowa City Iowa
United States University of California La Jolla California
United States Vanderbilt University Nashville Tennessee
United States Yale University New Haven Connecticut
United States Columbia Presbyterian Medical Center New York New York
United States New York University School of Medicine New York New York
United States Mayo Foundation Rochester Minnesota
United States Washington University Saint Louis Missouri
United States Brooke Army Medical Center San Antonio Texas
United States Walter Reed Army Medical Center Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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

Guess HA. Benign prostatic hyperplasia: antecedents and natural history. Epidemiol Rev. 1992;14:131-53. Review. — View 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. — View 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. — View 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. Review. — View 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, Ramsd — View Citation

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

* Note: There are 12 references in all — Click here to view all references

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