Dutasteride for Bladder Cancer
(DutaBCa-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether dutasteride, an oral medication, can prevent the recurrence of non-muscle-invasive bladder cancer. This is crucial because this cancer often recurs, leading to repeated surgeries and impacting patients' quality of life. Individuals diagnosed with this type of bladder cancer, who have not been recommended for treatments like BCG or chemotherapy, might be suitable for this study. The trial will also assess the safety of dutasteride for women. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that dutasteride is likely to be safe for humans?
Research has shown that dutasteride is generally well tolerated. In one study, patients using dutasteride had better chances of remaining disease-free. Another study with a large group of men found that those using dutasteride had an 18% lower risk of being diagnosed with bladder cancer compared to those who didn't use it.
Dutasteride also treats other conditions like prostate issues and has been shown to reduce the risk of sudden urinary problems without major safety concerns. Over two years, it has consistently been safe, with no significant side effects reported.
These findings suggest that dutasteride is a safe option for patients, with a history of being well tolerated over long-term use.12345Why do researchers think this study treatment might be promising for bladder cancer?
Dutasteride is unique because it offers a novel approach to treating bladder cancer by targeting the condition through hormone manipulation. Unlike traditional treatments like surgery, chemotherapy, or immunotherapy, which focus on removing or directly attacking cancer cells, dutasteride works by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a hormone that can influence cancer growth. Researchers are excited about this treatment because it represents a less invasive option that could potentially slow down or prevent tumor recurrence, providing a new avenue for managing bladder cancer with potentially fewer side effects.
What evidence suggests that dutasteride might be an effective treatment for bladder cancer?
Research has shown that dutasteride, a medication that blocks certain hormones, might help lower the chance of bladder cancer recurrence. Some studies found that people taking dutasteride had better chances of remaining disease-free. In a large group of men, those using dutasteride had an 18% lower risk of being diagnosed with bladder cancer compared to those who didn't use it. Although one study didn't find strong proof that dutasteride prevents bladder cancer from returning, there was a drop in recurrences after six months of use. Overall, dutasteride has shown promise in improving outcomes in related conditions. Participants in this trial will receive dutasteride 0.5 mg orally once daily for up to 2 years, or until tumor recurrence.12367
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dutasteride 0.5 mg orally once daily for up to 2 years or until tumor recurrence
Follow-up
Participants are monitored for safety and effectiveness after treatment, with extended follow-up for up to 4 years
Open-label extension (optional)
Participants may opt to continue dutasteride treatment after tumor recurrence for a total duration of up to 2 years
What Are the Treatments Tested in This Trial?
Interventions
- Dutasteride
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Paul Toren
Lead Sponsor
Citations
Effects of dutasteride with Bacillus Calmette-Guérin therapy on ...
Dutasteride users were associated with significantly improved disease-free survival, recurrence-free survival, and progression-free survival ( ...
The Long-Term Impact of 5-alpha Reductase Inhibitors on ...
This study aims to investigate the impact of 5ARIs on the development of BC and the implantation of RC utilizing national-wide data for a decade.
Anti-oncogenic effects of dutasteride, a dual 5-alpha ... - PMC
This study suggests that the 5α-reductase inhibitor dutasteride may play an anti-oncogenic role in BCa. Specifically, our results revealed that 5α-reductase ...
20-year follow-up data are in: Prostate cancer prevention ...
The authors found that dutasteride reduced the relative risk of prostate cancer by 22.8 percent over four years. While the total number of ...
5α-reductase inhibitors and the risk of bladder cancer in a ...
In a large cohort of men using 5ARI, there was a demonstrated decreased risk of BC diagnosis compared to a matched cohort of nonusers. This 18% risk reduction ...
6.
urologytimes.com
urologytimes.com/view/dutasteride-data-show-reduction-pca-risk-editorial-disputes-clinical-relevanceDutasteride data show reduction in PCa risk
There were 220 men (6.7%) on dutasteride with aggressive, high-grade tumors, compared with 233 men (6.8%) on placebo. However, the researchers noted a disparity ...
Effect of Dutasteride on the Risk of Prostate Cancer
Dutasteride significantly reduced the risk of acute urinary retention, the need for surgery related to benign prostatic hyperplasia, and urinary ...
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