Bladder CancerPhase 2DutaBCa-1NCT07420517
Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer
A Phase 2 study testing Dutasteride (0.5mg) in people with Bladder Cancer, run by Paul Toren at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Dutasteride (0.5mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2026to 2 Apr 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 and the presence of a low grade component;
- 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.
Who cannot join
- 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 who received a single, post-operative (<24h) intravesical chemotherapy (e.g. gemcitabine, epirubicin or mitomycin C) dose are eligible.
- 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. Nonetheless, patients with Gilbert's disease may be accepted in the study.
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- 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. Exceptions to this age limit may be permitted on a case-by-case basis by the Principal Investigator, based on documented confirmation that there is no child-bearing potential (such as a female without a uterus).
- Patients receiving chronic treatment with potent CYP3A4 inhibitors, including but not limited to ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycine, or ciprofloxacin, are ineligible for participation in the study. Occasional use of CYP3A4 inhibitors such as ciprofloxacin for an infection is not prohibited.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHU de Québec - Université Laval
Québec, Quebec, G1G 5X1
Marjorie Besançon, PhD, 418 525 4444, marjorie.besancon@crchudequebec.ulaval.ca
Catherine Gérard, PHd, 418 525 4444, Catherine.Gerard@crchudequebec.ulaval.ca
About this study
Official title: A Phase II Prospective Single-arm Study of Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer
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.
Read the detailed description
The study will therefore include two separate cohorts of men (n=70) and women (n=25).
After the screening phase, eligible male and female patients who provide informed consent will receive dutasteride at a dose of 0.5 mg once daily for the duration of the study. All participants will follow the same treatment regimen.
Treatment will be continued until tumor recurrence or for up to two years in the absence of recurrence. Prior data suggests a long-term mecanism of action of dutasteride in preventing tumor recurrences. Therefore, in the event of tumor recurrence, patients will be offered the option to continue dutasteride treatment for a total duration of up to two years. The decision to continue or discontinue treatment, as well as the reasons for this decision, will be documented.
Regarding analyses, the male cohort is designed to provide the first prospective data on efficacy; data will be compared to a historical control cohort, while also collecting adherence and safety data specific to men with low grade NMIBC.
The parallel female cohort is primarily intended to assess feasibility of recruitment and safety. In the published literature and our own institutional data, women represent approximately 25% of patients with low grade NMIBC. Recruitment of female patients is therefore more challenging, compounded in part by the limited safety data available and the absence of demonstrated urinary benefits. Consequently, this cohort aims to determine whether inclusion of women in a subsequent phase 3 study will be feasible and safe.
- Conditions
- Bladder Cancer
- Being tested
- Dutasteride (0.5mg)
- Keywords
- recurrence, 5-alpha-reductase inhibitor, Low-grade bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Dutasteride 0.5 mg oral treatment daily | Experimental | 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. Receives: Drug: Dutasteride (0.5mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of NMIBC recurrences in patients treated with dutasteride
To facilitate historical comparisons, a pathologic definition of recurrence is selected. Thus, investigators will be mandated to perform confirmatory biopsies or surgical resection of recurrences. For the female population, recruitment will be compared to the male population based on the established 1:3 ratio of female to male patients.
Measured: From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first
Secondary outcomes (8)
Time to surgery
Time to surgery under general anesthesia: time from enrolment until surgery for suspected recurrence of bladder cancer
Measured: From enrolment until surgery for suspected recurrence of bladder cancer or 4 years of extended follow-up, whichever occurs first
Incidence of tumour progression
The proportion of patients who experienced tumor progression at the end of follow-up. Progression is defined as a recurrence with an increase in tumour grade to high grade, or an increase in stage, or the new presence of CIS.
Measured: From enrolment until first progression or 4 years of extended follow-up, whichever occurs first
Number of tumour recurrences:
This is defined as the number of recurrences per patient.
Measured: From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first
Number of tumours at recurrence
This is defined as the number of tumors at the recurrence. This information is based on cystoscopic findings at time of the cystoscopy preceding surgical resection or the cystoscopy without anesthesia at which the biopsy indicating recurrence was taken.
Measured: From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first
Concordance of cystoscopic recurrence with pathologic recurrence
The proportion of suspected pathologic recurrences which were confirmed urothelial carcinoma on pathologic analysis
Measured: From enrolment until 4 years of extended follow-up, whichever occurs first
Quality of life assessed by the European Organisation for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire (QLQ) non-muscle invasive bladder cancer questionnaire(NMIBC) module 24
Quality of life will be evaluated with the EORTC QLQ-NMIBC24 questionnaire as a global score (linear transformation to 0-100, higher=better).
Measured: From enrolment to 24 months (end of treatment)
Urinary symptoms assessed by Bladder Utility Symptom Score (BUSS)
Urinary symptoms will be evaluated using BUSS questionnaire (0-100, higher=better)
Measured: From enrollment until 2 years (end of treatment)
Urinary symptoms assessed by the Internation Prostate Symptom Score (IPSS) questionnaire
Urinary symptoms will be evaluated using the IPSS(0-35, mild (0-7), moderate (8-19), or severe (20-35)) questionnaire among male patients.
Measured: From enrollment until 2 years (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start25 Mar 2026
- Primary completion2 Apr 2030 (estimated)
- Study completion2 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will therefore include two separate cohorts of men (n=70) and women (n=25).
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Toren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Toren, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420517
- Sponsor's protocol ID
- MP-20-2026-8412
- Acronym
- DutaBCa-1
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective Single-arm Study of Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07420517
- Acronym / sponsor ID
- DutaBCa-1 / MP-20-2026-8412
- Conditions
- Bladder Cancer
- Keywords
- recurrence, 5-alpha-reductase inhibitor, Low-grade bladder cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Paul TorenUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 2 Apr 2030 (estimated)
- Study completion
- 2 Apr 2032 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will therefore include two separate cohorts of men (n=70) and women (n=25).
After the screening phase, eligible male and female patients who provide informed consent will receive dutasteride at a dose of 0.5 mg once daily for the duration of the study. All participants will follow the same treatment regimen.
Treatment will be continued until tumor recurrence or for up to two years in the absence of recurrence. Prior data suggests a long-term mecanism of action of dutasteride in preventing tumor recurrences. Therefore, in the event of tumor recurrence, patients will be offered the option to continue dutasteride treatment for a total duration of up to two years. The decision to continue or discontinue treatment, as well as the reasons for this decision, will be documented.
Regarding analyses, the male cohort is designed to provide the first prospective data on efficacy; data will be compared to a historical control cohort, while also collecting adherence and safety data specific to men with low grade NMIBC.
The parallel female cohort is primarily intended to assess feasibility of recruitment and safety. In the published literature and our own institutional data, women represent approximately 25% of patients with low grade NMIBC. Recruitment of female patients is therefore more challenging, compounded in part by the limited safety data available and the absence of demonstrated urinary benefits. Consequently, this cohort aims to determine whether inclusion of women in a subsequent phase 3 study will be feasible and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will therefore include two separate cohorts of men (n=70) and women (n=25).
| Arm | Type | Receives |
|---|---|---|
| Dutasteride 0.5 mg oral treatment daily | Experimental | Drug: Dutasteride (0.5mg)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 and the presence of a low grade component;
- 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.
Key exclusion criteria (9 listed)
- 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 who received a single, post-operative (<24h) intravesical chemotherapy (e.g. gemcitabine, epirubicin or mitomycin C) dose are eligible.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dutasteride (0.5mg)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. | Drug | Dutasteride 0.5 mg oral treatment daily |
Primary outcome
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
To facilitate historical comparisons, a pathologic definition of recurrence is selected. Thus, investigators will be mandated to perform confirmatory biopsies or surgical resection of recurrences. For the female population, recruitment will be compared to the male population based on the established 1:3 ratio of female to male patients.
8 secondary outcomes
Time to surgery
Time frame: From enrolment until surgery for suspected recurrence of bladder cancer or 4 years of extended follow-up, whichever occurs first
Incidence of tumour progression
Time frame: From enrolment until first progression or 4 years of extended follow-up, whichever occurs first
Number of tumour recurrences:
Time frame: From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first
Number of tumours at recurrence
Time frame: From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first
Concordance of cystoscopic recurrence with pathologic recurrence
Time frame: From enrolment until 4 years of extended follow-up, whichever occurs first
Quality of life assessed by the European Organisation for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire (QLQ) non-muscle invasive bladder cancer questionnaire(NMIBC) module 24
Time frame: From enrolment to 24 months (end of treatment)
Urinary symptoms assessed by Bladder Utility Symptom Score (BUSS)
Time frame: From enrollment until 2 years (end of treatment)
Urinary symptoms assessed by the Internation Prostate Symptom Score (IPSS) questionnaire
Time frame: From enrollment until 2 years (end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dutasteride (0.5mg) in people with Bladder Cancer, run by Paul Toren at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Toren Principal Investigator, MD (418 525 4444, Paul.Toren@crchudequebec.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.