Bladder Cancer study: Dutasteride
Official title Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT07420517
What this study is testing
What is Dutasteride (0.5mg)?
Dutasteride (0.5mg) is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for bladder cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will find out whether dutasteride can lower the chance of bladder cancer returning and whether it is safe, especially for women.
- Who it's for
- People who have low‑grade non‑muscle‑invasive bladder cancer.
- What's involved
- Participants will take a daily dutasteride tablet and attend scheduled visits for exams and urine tests.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged 18 or greater;
- Patients with histologically confirmed low grade non-muscle invasive urothelial carcinoma.
- Patients have not been recommended for a course of intravesical BCG or chemotherapy induction treatment by their urologist;
- Male patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 6 months after...
You likely can't join if
- Patients who are scheduled to receive BCG therapy or have received BCG therapy within the last 5 years will be ineligible for enrollment.
- Patients who are scheduled to receive intravesical chemotherapy or have received an induction course of intravesical chemotherapy within the last 5...
- Patients with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with various...
- Patients receiving 5-alpha-reductase inhibitors within the last 2 years are ineligible for enrollment.
- Patients with a history of allergy or severe adverse reaction to finasteride or dutasteride are ineligible for enrollment.
- Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal...
See the full eligibility criteria
- Patients aged 18 or greater;
- Patients with histologically confirmed low grade non-muscle invasive urothelial carcinoma. Patients with any mix of low- and high-grade urothelial carcinoma remain eligible given the frequent histological heterogeneity...
- Patients have not been recommended for a course of intravesical BCG or chemotherapy induction treatment by their urologist;
- Male patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 6 months after study drug is discontinued.
- Patients who are scheduled to receive BCG therapy or have received BCG therapy within the last 5 years will be ineligible for enrollment.
- Patients who are scheduled to receive intravesical chemotherapy or have received an induction course of intravesical chemotherapy within the last 5 years will be ineligible for enrollment.
- Patients with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with various forms of hormonal therapy will be ineligible for study enrollment.
- Patients receiving 5-alpha-reductase inhibitors within the last 2 years are ineligible for enrollment.
- Patients with a history of allergy or severe adverse reaction to finasteride or dutasteride are ineligible for enrollment.
- Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible.
- Patients with multiple hospital admissions for heart failure within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrolment.
- Female patients with child-bearing potential are ineligible for enrollment, which is defined as any female under 50 years of age.
- Patients receiving chronic treatment with potent CYP3A4 inhibitors, including but not limited to ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycine, or ciprofloxacin, are ineligible for...
The study team makes the final eligibility decision.
Where it is enrolling
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.