Non-Muscle Invasive Bladder CancerPhase 2BicaBCaNCT05327647
A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
A Phase 2 study testing Bicalutamide in people with Non-Muscle Invasive Bladder Cancer, run by CHU de Quebec-Universite Laval at 7 sites in Canada.
Trial summary
This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer
- What is being tested?
- Bicalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 7 sitesCanada
- Study dates
- 23 Jun 2022to 31 Dec 2027
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, age 18 or greater.
- Patients with histologically confirmed non-muscle invasive urothelial carcinoma.
- Patients have been recommended for a course of intravesical BCG induction treatment by their urologist
- Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.
- Patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 3 months after study drug is discontinued.
Who cannot join
- Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrolment.
- Patients with a history of myocardial infarction or hospital admission for heart failure within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrolment.
- Patients who have uncontrolled hypertension (for our purposes, defined as those having a systolic blood pressure > 160 documented on 2 occasions despite appropriate medical therapy) will similarly be ineligible.
- 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 clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with systemic hormonal therapy will be ineligible for study enrolment. Patients receiving 5ARIs will not be excluded.
- Patients who have cancer treatment ongoing or planned in the near future which can be anticipated to decrease their 2-year survival or BCa treatment plan will be ineligible.
- Patients taking an investigational drug within 2 weeks of enrolment into this study will be ineligible.
- Patients receiving or planning to receive coumadin therapy will be ineligible.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Recruiting
Centre intégré de santé et services sociaux de Chaudière Appalaches
Lévis, Quebec, G6V3Z1
Matthieu Gratton, MD, (418) 835-7121, matthieu.gratton.med@sss.gouv.qc.ca
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Melissa Huynh, MD, 519-685-8451, Melissa.Huynh@LHSC.on.ca
- Recruiting
Centre Hospitalier de l'Université De Montréal_CHUM
Montreal, Quebec, H2X 3E4
Jean-Baptiste Lattouf, MD
- Recruiting
McGill University Health Centre_CUSM
Montreal, Quebec, H4A 3J1
Wassim Kassouf, MDCM, (514) 934-8246, wassim.kassouf.med@ssss.gouv.qc.ca
- Recruiting
CHU de Québec-Université Laval
Québec, Quebec, G1G 5X1
Paul Toren, MD, 418-525-4444 ext. 17064, Paul.toren@crchudequebec.ulaval.ca
Typhaine Gris, PhD, 418 525-4444 ext. 20417, typhaine.gris@crchudequebec.ulaval.ca
- Recruiting
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 5H3
Patrick Richard, MD, 819-346-1110, Patrick.Richard@usherbrooke.ca
- Recruiting
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
Girish Kulkarni, BSc, MD, PhD, FRCSC, Girish.kulkarni@uhn.ca
About this study
Official title: A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer.
Read the detailed description
Bladder cancer is the second most common urological cancer after prostate cancer. Non-muscle invasive bladder cancer (NIMBC) is the most common form (~ 75%). The standard treatment involves the use of intravesical instillation of bacillus Calmette-Guérin (BCG). Nonetheless, 30-40% of the patients still relapse or progress. Clinical and laboratory research suggests that medications targeting the androgen receptor, such as bicalutamide, combined with the standard treatment with BCG may decrease the recurrence rate of NMIBC.
The study is composed of two cohort A (open-label, around 40 patients) and B (double-blind, with placebo, around 120 patients).
In the cohort A, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) the standard of care of 6 cycles of intravesical instillation BCG.
In the cohort B, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) daily intake of 150mg placebo for 3 months + the standard of care of 6 cycles of intravesical instillation BCG.
The participation in this trial should last 36 months from the screening visit to the last follow-up visit.
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Being tested
- Bicalutamide, Control Arm
- Keywords
- Bicalutamide, BCG instillation, Placebo
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
Also called Nonsteroidal antiandrogen
Induction intravesical BCG with bicalutamide 150 mg for 90 days
Control ArmBiological
Induction BCG
| Study group | Role | What they receive |
|---|---|---|
| Bicalutamide | Experimental | Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days (in cohort A and cohort B) Receives: Drug: Bicalutamide |
| Control Arm | Active comparator | cohort A: Induction intravesical Bacille Calmette-Guérin treatment
cohort B: Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral placebo for 90 days Receives: Biological: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bladder tumour recurrence
To time to bladder tumor recurrence compared to the standard of care induction BCG
Measured: 3 years
Secondary outcomes (5)
Incidence of tumour progression
To compare the incidence of tumor progression between the intervention and control arms
Measured: 3 years
Number of tumor recurrences
To compare the overall incidence of tumor recurrences between intervention and control arms
Measured: 3 years
Number of tumours at first recurrence
Evaluation of the number of tumours at first recurrence between the two arms
Measured: 3 years
Quality of life (QLQ-C30)
Evaluation of quality of life with QLQ-C30 questionnaire (EORTC Core Quality of Life questionnaire). The scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom
Measured: 3 years
Evaluation of urinary symptoms
Evaluation of urinary symptoms with International Prostate Symptom Score (IPSS) . questionnaire. The total score can range from 0 to 35 (0 being asymptomatic and 35 being very symptomatic).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start23 Jun 2022
- Primary completion1 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study started with cohort A (open-label study) for around 40 participants. Then the recruitment in cohort A will stop and the recruitment in cohort B (double-blind, with placebo) will start.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Cancer Research Society
- Responsible party
- Sponsor
- Investigators
- Paul Toren, MD,PhD,FRCSC, Study chair, CHU de Québec-Université LavalWassim Kassouf, MDCM,FRCSC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMelissa Huynh, MD,MPH,FRCSC, Principal investigator, London Health Sciences Centre, Victoria HospitalJean-Baptiste Lattouf, MD,FRCSC, Principal investigator, Centre Hospitalier Universitaire de Montréal (CHUM)Girish Kulkarni, BSc, MD, PhD, FRCSC, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327647
- Sponsor's protocol ID
- MP-20-2022-6318
- Acronym
- BicaBCa
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT05327647
- Acronym / sponsor ID
- BicaBCa / MP-20-2022-6318
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Keywords
- Bicalutamide, BCG instillation, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Cancer Research Society
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Apr 2022 (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.
This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer.
Detailed description
Bladder cancer is the second most common urological cancer after prostate cancer. Non-muscle invasive bladder cancer (NIMBC) is the most common form (~ 75%). The standard treatment involves the use of intravesical instillation of bacillus Calmette-Guérin (BCG). Nonetheless, 30-40% of the patients still relapse or progress. Clinical and laboratory research suggests that medications targeting the androgen receptor, such as bicalutamide, combined with the standard treatment with BCG may decrease the recurrence rate of NMIBC.
The study is composed of two cohort A (open-label, around 40 patients) and B (double-blind, with placebo, around 120 patients).
In the cohort A, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) the standard of care of 6 cycles of intravesical instillation BCG.
In the cohort B, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) daily intake of 150mg placebo for 3 months + the standard of care of 6 cycles of intravesical instillation BCG.
The participation in this trial should last 36 months from the screening visit to the last follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study started with cohort A (open-label study) for around 40 participants. Then the recruitment in cohort A will stop and the recruitment in cohort B (double-blind, with placebo) will start.
| Arm | Type | Receives |
|---|---|---|
| Bicalutamide | Experimental | Drug: BicalutamideInduction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days (in cohort A and cohort B) |
| Control Arm | Active comparator | Biological: Control Armcohort A: Induction intravesical Bacille Calmette-Guérin treatment cohort B: Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral placebo for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males, age 18 or greater.
- Patients with histologically confirmed non-muscle invasive urothelial carcinoma.
- Patients have been recommended for a course of intravesical BCG induction treatment by their urologist
- Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.
- Patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 3 months after study drug is discontinued.
Key exclusion criteria (8 listed)
- Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrolment.
- Patients with a history of myocardial infarction or hospital admission for heart failure within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrolment.
- Patients who have uncontrolled hypertension (for our purposes, defined as those having a systolic blood pressure > 160 documented on 2 occasions despite appropriate medical therapy) will similarly be ineligible.
- 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 clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with systemic hormonal therapy will be ineligible for study enrolment. Patients receiving 5ARIs will not be excluded.
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 |
|---|---|---|
| BicalutamideAlso: Nonsteroidal antiandrogenInduction intravesical BCG with bicalutamide 150 mg for 90 days | Drug | Bicalutamide |
| Control ArmInduction BCG | Biological | Control Arm |
Primary outcome
Rate of bladder tumour recurrence
Time frame: 3 years
To time to bladder tumor recurrence compared to the standard of care induction BCG
5 secondary outcomes
Incidence of tumour progression
Time frame: 3 years
Number of tumor recurrences
Time frame: 3 years
Number of tumours at first recurrence
Time frame: 3 years
Quality of life (QLQ-C30)
Time frame: 3 years
Evaluation of urinary symptoms
Time frame: 3 years
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Paul Toren, MD,PhD,FRCSC study chair
CHU de Québec-Université Laval
Wassim Kassouf, MDCM,FRCSC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Melissa Huynh, MD,MPH,FRCSC principal investigator
London Health Sciences Centre, Victoria Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bicalutamide in people with Non-Muscle Invasive Bladder Cancer, run by CHU de Quebec-Universite Laval at 7 sites 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 5 inclusion and 8 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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, MD,PhD,FRCSC (418-525-4444 ext. 17064, 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?
Rate of bladder tumour recurrence (time frame: 3 years). 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 26 Oct 2026.