Prostatic Hyperplasia Clinical Trial
— MTOPSOfficial title:
Medical Therapy of Prostatic Symptoms
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | George Washington University |
United States,
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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