Tranilast for medium-to-large benign prostate enlargement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase interventional study will enroll 30 men with medium-to-large benign prostatic hyperplasia to explore the safety and preliminary efficacy of tranilast. Participants will receive either an alpha receptor antagonist or tranilast at one of two dose levels, with investigators tracking prostate volume, IPSS symptom scores, maximum urinary flow rate, and adverse events. The trial is based on preclinical data showing that mast cell stabilization and TGF-β pathway inhibition by tranilast reduced prostate enlargement in animal models. Findings will inform dosing, safety, and whether larger controlled trials are warranted.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with benign prostatic hyperplasia aged 55 to 75 years old;
* The patient's prostate volume is greater than 40mL;
* There is urinary obstruction, with an International Prostate Symptom Score (IPSS) greater than or equal to 8 points, and a maximum urinary flow rate of less than 15ml/s (urinary flow rate is not measured in patients with indwelling catheters).

Exclusion Criteria:

* Urinary disorders caused by neurogenic diseases;
* Acute urinary tract infections have not been effectively controlled;
* There are factors of lower urinary tract obstruction other than BPH, such as urethral stricture;
* History of radiation therapy or surgery in the lower urinary tract or pelvic cavity;
* Have ever suffered from tumor of urinary system, or suspected of suffering from tumor of urinary system (such as bladder cancer cancer, prostate cancer);
* Current or past liver function abnormalities (exceeding the test reference value limit);
* Abnormal renal function (exceeding the test reference value limit);
* Currently taking warfarin;
* Allergic to tranilast or drug preparations;
* Suffering from other major diseases (malignant tumors, autoimmune diseases, angina pectoris, heart failure, severe respiratory and digestive diseases, etc.), and not yet clinically cured;
* Other researchers believe that patients who are not suitable to participate in this trial.

Where it's running

• Shanghai General Hospital
  Shanghai, Outside U.S./Canada, China Recruiting
• Shanghai General Hospital
  Shanghai, China Not yet recruiting

Study contacts

• Study coordinator: Yifeng Jing
• Email: jyf_123@163.com
• Phone: +86-13918839913

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.