Can a newer prostate drug outperform the standard?

NCT ID NCT05551221

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This trial tests whether silodosin, a medication that relaxes prostate and bladder muscles, works better than tamsulosin for men with an enlarged prostate and bothersome urinary symptoms. About 110 men aged 60 to 80 will take one of the two drugs for 12 weeks. Researchers will measure changes in symptom scores to see which drug provides more relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
silodosin
What this could lead to
If silodosin proves more effective or safer than tamsulosin, it could become a preferred treatment for men with enlarged prostate and urinary symptoms.
What could go wrong
This is a phase 4 trial with 110 participants, so results may not apply to everyone. Silodosin can cause side effects like dizziness, low blood pressure, and ejaculation problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

110 people

The number who actually took part.

Started

Sep 2022

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male Subjects aged 60 ~ 80 years, clinically diagnosed as benign prostatic hyperplasia. 2. Has an IPSS score ≥ 8 points at Screening and Baseline. 3. Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume \> 150 ml. 4. Has a prostate volume (PV) ≥ 30 ml by ultrasound examination. 5. Subjects who can read, understand, and complete the research questionnaire. 6. Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent. Exclusion Criteria: 1. Subjects with prostate cancer or other malignant tumors. 2. Subjects have serum tPSA \> 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA \< 0.16 times. 3. Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc. 4. Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications. 5. Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures. 6. Subjects have residual urine volume (PVR) \> 100ml, or those who may have urinary retention and need catheterization. 7. Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial. 8. Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial. 9. Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment. 10. Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases. 11. There are significant abnormalities in clinical or laboratory examination indexes of patients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value, creatinine (Scr) \> 1.5 times of the upper limit of reference value, or poor blood glucose control (fasting blood glucose FPG ≥ 10 mmol/L). 12. Subjects who are allergic to the drugs or ingredients used in the test definitely. 13. Any otherSubjects in the opinion of researchers is not suitable for inclusion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, China

  • The Central Hospital Of WUHAN

    Wuhan, Hubei, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, China

  • Wuhan No.1 Hospital

    Wuhan, Hubei, China

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu, China

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