Tranilast for medium-to-large benign prostate enlargement

Study on the Effectiveness of Tranilast in the Treatment of Medium to Large Volume Benign Prostatic Hyperplasia

This trial will try tranilast to see if it can reduce prostate size and improve urinary symptoms in men aged 55–75 with medium-to-large benign prostate enlargement.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 55 Years to 75 Years
• Sex: Male
• Sponsor: Shanghai General Hospital, China (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Shanghai, Outside U.S./Canada and 1 other locations)
• Trial ID: NCT06689514 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Men aged 55–75 with benign prostatic hyperplasia, prostate volume greater than 40 mL, IPSS ≥8, and maximum urinary flow rate below 15 mL/s (or with an indwelling catheter) are the intended candidates.

Not a fit: Patients with urinary problems due to neurogenic disease, non-BPH anatomic obstruction (e.g., urethral stricture), uncontrolled urinary infection, prior lower urinary tract or pelvic surgery/radiation, suspected or known urinary tract tumors, or significant liver or kidney dysfunction are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, tranilast could reduce prostate volume or urinary symptoms and potentially lower the need for surgery in men with larger BPH.

How similar studies have performed: Preclinical animal studies reported that tranilast reduced prostate enlargement, but clinical use for BPH is novel and there are not yet large human trials showing efficacy.

Eligibility criteria

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 this trial is running

Shanghai, Outside U.S./Canada and 1 other locations

• Shanghai General Hospital — Shanghai, Outside U.S./Canada, China (RECRUITING)
• Shanghai General Hospital — Shanghai, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Yifeng Jing

Conditions: Prostatic Hypertrophy, Benign, Prostatic Hypertrophy