Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer

Sponsor
Paul Toren
Study ID
NCT07420517
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dutasteride (0.5mg) — DRUG
    Dutasteride 0.5 mg orally once daily. Treatment begins after enrollment and continues for 2 years or until tumor recurrence. Patients may opt to continue treatment after recurrence for a total of 2 years.

Study Details

Low grade non-muscle-invasive bladder cancer (NMIBC) often recurs after treatment, requiring repeated surgeries, especially in older patients. These recurrences can cause complications, reduce quality of life, and increase healthcare costs. Currently, there is no well-tolerated preventive treatment routinely used for patients with low-risk disease. This study will evaluate whether dutasteride, an oral medication that blocks androgen activity, can reduce the risk of bladder cancer recurrence. Dutasteride is generally well tolerated and easy to take. The study will also assess its safety in women. The goal of this study is to determine whether dutasteride can provide a simple and effective way to prevent recurrences of low grade non-muscle invasive bladder cancer.

Key Dates

First listed
Feb 19, 2026
Start date
Mar 25, 2026
Status verified
Mar 2026
Primary completion
Apr 2, 2030
Completion
Apr 2, 2032

Study Design

Enrollment
95 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dutasteride 0.5 mg oral treatment daily
    Participants will receive dutasteride 0.5 mg orally once daily for up to 2 years, or until tumor recurrence. Treatment may be continued after recurrence up to 2 years total, if the patient chooses to continue.

Primary Outcome Measure

Incidence of NMIBC recurrences in patients treated with dutasteride [ Time Frame: From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first ]

Central Contacts

Find similar trials

Nationwide
Bladder cancer trialsOncology trialsUrology trials

Related Studies