Medical Therapy of Prostatic Symptoms (MTOPS)

• ClinicalTrials.gov Identifier: NCT00021814
• Recruitment Status: Completed
• First Posted: August 6, 2001
• Last Update Posted: September 28, 2018
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: George Washington University
• Information provided by (Responsible Party): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information

• First Submitted Date: August 4, 2001
• First Posted Date: August 6, 2001
• Last Update Posted Date: September 28, 2018
• Actual Study Start Date: December 1995
• Actual Primary Completion Date: November 30, 2001 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Medical Therapy of Prostatic Symptoms
• Official Title: Medical Therapy of Prostatic Symptoms

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; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Prostatic Hyperplasia
• Prostatic Hypertrophy, Benign

Intervention

• Drug: Doxazosin
• Drug: Finasteride
• Drug: Doxazosin placebo
• Drug: Finasteride placebo

Study Arms

• Placebo Comparator: Placebo
  Doxazosin and Finasteride placebos
  Interventions:

  • Drug: Doxazosin placebo
  • Drug: Finasteride placebo
• Experimental: Doxazosin
  Doxazosin and Finasteride placebo
  Interventions:

  • Drug: Doxazosin
  • Drug: Finasteride placebo
• Experimental: Finasteride
  Doxazosin placebo and Finasteride
  Interventions:

  • Drug: Finasteride
  • Drug: Doxazosin placebo
• Experimental: Combination
  Doxazosin and Finasteride
  Interventions:

  • Drug: Doxazosin
  • Drug: Doxazosin placebo

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• Guess HA. Benign prostatic hyperplasia: antecedents and natural history. Epidemiol Rev. 1992;14:131-53. Review.
• McConnell JD. Androgen ablation and blockade in the treatment of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):661-70. Review.
• Barry MJ. Epidemiology and natural history of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):495-507. Review.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 26, 2018): 3407
• Original Enrollment (submitted: June 23, 2005): 2931
• Actual Study Completion Date: November 30, 2001
• Actual Primary Completion Date: November 30, 2001 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00021814
• Other Study ID Numbers: MTOPS (completed); U01DK046472 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data and specimens will be submitted to the NIDDK Central Repository
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: 2006
• URL: https://repository.niddk.nih.gov/studies/mtops/?query=mtops

• Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: George Washington University

Investigators

• Principal Investigator: E. David Crawford; Clinic 01 - Univ of Colorado Health Sciences Center
• Principal Investigator: Steven A. Kaplan; Clinic 02 - New York Presbyterian Hospital
• Principal Investigator: Claus Roehrborn; Clinic 03 - UT Southwestern Medical Center
• Principal Investigator: Noah S. Schenkman; Clinic 04 - Walter Reed Army Medical Center
• Principal Investigator: Herbert Lepor; Clinic 06 - New York University School of Medicine
• Principal Investigator: Kevin M. Slawin; Clinic 07 - Baylor College of Medicine
• Principal Investigator: John P. Foley; Clinic 08 - Brooke Army Medical Center
• Principal Investigator: Joe W. Ramsdell; Clinic 09 - University of California San Diego
• Principal Investigator: Mani Menon; Clinic 10 - Henry Ford Hospital
• Principal Investigator: Michael M. Lieber; Clinic 11 - Mayo Foundation
• Principal Investigator: Kevin T. McVary; Clinic 12 - Northwestern University
• Principal Investigator: Joseph A. Smith; Clinic 13 - Vanderbilt University
• Principal Investigator: Gerald L. Andriole; Clinic 14 - Washington University
• Principal Investigator: Harris E. Foster; Clinic 15 - Yale University
• Principal Investigator: Harry S. Clarke; Clinic 16 - Emory University
• Principal Investigator: Karl J. Kreder; Clinic 17 - University of Iowa
• Principal Investigator: Stephen C. Jacobs; Clinic 18 - University of Maryland
• Principal Investigator: Gary J. Miller; Diagnostic Center - Univ of Colorado Health Sciences Center
• Principal Investigator: Oliver M. Bautista; Biostatistical Coordinating Center - George Washington Univ.

• PRS Account: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Verification Date: September 2018