Prostatic HyperplasiaPhase 3MTOPSNCT00021814

Medical Therapy of Prostatic Symptoms

A Phase 3 study testing Doxazosin and Finasteride in people with Prostatic Hyperplasia and Prostatic Hypertrophy, Benign, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 50 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Prostatic Hyperplasia, Prostatic Hypertrophy, Benign
What is being tested?: Doxazosin and Finasteride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,407 participants
Where: 17 sitesUnited States
Study dates: Dec 1995to 30 Nov 2001
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Emory University
Atlanta, Georgia, 30322
Univ of Colorado Health Sciences Center
Aurora, Colorado, 80010-0510
University of Maryland
Baltimore, Maryland, 21201
Northwestern University
Chicago, Illinois, 60611
UT Southwestern Medical Center
Dallas, Texas, 5235-9110
Henry Ford Health Systems
Detroit, Michigan, 48202
Baylor College of Medicine
Houston, Texas, 77005
University of Iowa Hospitals Clinics
Iowa City, Iowa, 52242
University of California
La Jolla, California, 92093-0694
Vanderbilt University
Nashville, Tennessee, 37232-2765
Yale University
New Haven, Connecticut, 06520
New York University School of Medicine
New York, New York, 10010
Columbia Presbyterian Medical Center
New York, New York, 10032
Mayo Foundation
Rochester, Minnesota, 55905
Brooke Army Medical Center
San Antonio, Texas, 78234-6200
Washington University
St Louis, Missouri, 63141
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307

Other trials in United States

About this study

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.

Conditions: Prostatic Hyperplasia, Prostatic Hypertrophy, Benign
Being tested: Doxazosin, Finasteride, Doxazosin placebo, Finasteride placebo
Keywords: BPH progression, Medical Therapy, Finasteride, Doxazosin, Randomized, Multi-center, Clinical Trial, Proscar, Cardura
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DoxazosinDrug
FinasterideDrug
Doxazosin placeboDrug
Finasteride placeboDrug

Study groups in NCT00021814
Study group	Role	What they receive
Placebo	Placebo comparator	Doxazosin and Finasteride placebos Receives: Drug: Doxazosin placebo; Drug: Finasteride placebo
Doxazosin	Experimental	Doxazosin and Finasteride placebo Receives: Drug: Doxazosin; Drug: Finasteride placebo
Finasteride	Experimental	Doxazosin placebo and Finasteride Receives: Drug: Finasteride; Drug: Doxazosin placebo
Combination	Experimental	Doxazosin and Finasteride Receives: Drug: Doxazosin; Drug: Doxazosin placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 199530 Nov 2001

First posted6 Aug 2001 (estimated)
Study startDec 1995
Primary completion30 Nov 2001
Study completion30 Nov 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3,407 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00021814
Sponsor's protocol ID: MTOPS (completed)
Other IDs: U01DK046472
Acronym: MTOPS
Status last verified: Sep 2018
First submitted: 4 Aug 2001
Last updated: 28 Sep 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Data and specimens will be submitted to the NIDDK Central Repository

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. doi: 10.1016/s0022-5347(17)49698-4.
PubMed 6206240
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.
PubMed 1719806
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.
PubMed 1383816
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.
PubMed 2462301
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.
PubMed 1711689
Guess HA. Benign prostatic hyperplasia: antecedents and natural history. Epidemiol Rev. 1992;14:131-53. doi: 10.1093/oxfordjournals.epirev.a036083. No abstract available.
PubMed 1283852
McConnell JD. Androgen ablation and blockade in the treatment of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):661-70.
PubMed 1695786
Barry MJ. Epidemiology and natural history of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):495-507.
PubMed 1695778
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.
PubMed 2643719
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.
PubMed 14681504
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.
PubMed 11796283
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.
PubMed 12689743
Long B, Cheema A, Copelan O, Joyce C, Feffer M, McVary KT. Five-Year Outcomes of Water Vapor Therapy vs Doxazosin, Finasteride, and Combination Therapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Cohort Data From the Medical Therapy of Prostatic Symptoms Trial. Urology. 2025 Dec;206:142-149. doi: 10.1016/j.urology.2025.07.016. Epub 2025 Jul 17.
PubMed 40683564

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
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All Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medical Therapy of Prostatic Symptoms
ClinicalTrials.gov ID: NCT00021814
Acronym / sponsor ID: MTOPS / MTOPS (completed)
Conditions: Prostatic Hyperplasia, Prostatic Hypertrophy, Benign
Keywords: BPH progression, Medical Therapy, Finasteride, Doxazosin, Randomized, Multi-center, Clinical Trial, Proscar
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,407 participants (actual)
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
Collaborators: George Washington University
Study start: Dec 1995 (actual)
Primary completion: 30 Nov 2001 (actual)
Study completion: 30 Nov 2001 (actual)
First posted: 6 Aug 2001 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Doxazosin placebo, Drug: Finasteride placeboDoxazosin and Finasteride placebos
Doxazosin	Experimental	Drug: Doxazosin, Drug: Finasteride placeboDoxazosin and Finasteride placebo
Finasteride	Experimental	Drug: Finasteride, Drug: Doxazosin placeboDoxazosin placebo and Finasteride
Combination	Experimental	Drug: Doxazosin, Drug: Doxazosin placeboDoxazosin and Finasteride

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Doxazosin	Drug	Combination, Doxazosin
Finasteride	Drug	Finasteride
Doxazosin placebo	Drug	Combination, Finasteride, Placebo
Finasteride placebo	Drug	Doxazosin, Placebo

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
Background: PubMed 6206240Berry 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.
Background: PubMed 1719806Sidney 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.
Background: PubMed 1383816Gormley 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.
Background: PubMed 2462301Lepor 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.
Background: PubMed 1711689Lepor 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.
Background: PubMed 1283852Guess HA. Benign prostatic hyperplasia: antecedents and natural history. Epidemiol Rev. 1992;14:131-53. doi: 10.1093/oxfordjournals.epirev.a036083. No abstract available.
Background: PubMed 1695786McConnell JD. Androgen ablation and blockade in the treatment of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):661-70.
Background: PubMed 1695778Barry MJ. Epidemiology and natural history of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):495-507.
Background: PubMed 2643719Mebust 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.
Results publication: PubMed 14681504McConnell 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.
Results publication: PubMed 11796283Kusek 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.
Results publication: PubMed 12689743Bautista 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.
MTOPS public access site. Userid and password not required.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Data and specimens will be submitted to the NIDDK Central Repository

Related trials for Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

E. David Crawford principal investigator

Clinic 01 - Univ of Colorado Health Sciences Center

Steven A. Kaplan principal investigator

Clinic 02 - New York Presbyterian Hospital

Claus Roehrborn principal investigator

Clinic 03 - UT Southwestern Medical Center

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00021814, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.