Clinical trial NCT00021814: Medical Therapy of Prostatic Symptoms
Official title: Medical Therapy of Prostatic Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Hyperplasia
Prostatic Hypertrophy, Benign
Keywords: BPH progression
Medical Therapy
Finasteride
Doxazosin
Randomized
Multi-center
Clinical Trial
Proscar
Cardura
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: George Washington University
First posted: 2001-08-06
Enrollment: 3407
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California
state: California
city: Aurora
country: United States
facility: Univ of Colorado Health Sciences Center
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals Clinics
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: Rochester
country: United States
facility: Mayo Foundation
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Clinic 01 - Univ of Colorado Health Sciences Center
name: E. David Crawford
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 02 - New York Presbyterian Hospital
name: Steven A. Kaplan
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 03 - UT Southwestern Medical Center
name: Claus Roehrborn
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 04 - Walter Reed Army Medical Center
name: Noah S. Schenkman
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 06 - New York University School of Medicine
name: Herbert Lepor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 07 - Baylor College of Medicine
name: Kevin M. Slawin
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 08 - Brooke Army Medical Center
name: John P. Foley
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 09 - University of California San Diego
name: Joe W. Ramsdell
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 10 - Henry Ford Hospital
name: Mani Menon
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 11 - Mayo Foundation
name: Michael M. Lieber
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 12 - Northwestern University
name: Kevin T. McVary
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 13 - Vanderbilt University
name: Joseph A. Smith
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 14 - Washington University
name: Gerald L. Andriole
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 15 - Yale University
name: Harris E. Foster
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 16 - Emory University
name: Harry S. Clarke
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 17 - University of Iowa
name: Karl J. Kreder
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic 18 - University of Maryland
name: Stephen C. Jacobs
role: PRINCIPAL_INVESTIGATOR
affiliation: Diagnostic Center - Univ of Colorado Health Sciences Center
name: Gary J. Miller
role: PRINCIPAL_INVESTIGATOR
affiliation: Biostatistical Coordinating Center - George Washington Univ.
name: Oliver M. Bautista
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: McConnell JD. Androgen ablation and blockade in the treatment of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):661-70.
citation: Barry MJ. Epidemiology and natural history of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):495-507.
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.
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.
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.
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.