Non-Muscle Invasive Bladder Cancer study: Bicalutamide
Official title A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT05327647
What this study is testing
What is Bicalutamide?
Bicalutamide is an investigational medicine, being studied as a potential treatment for non-muscle invasive bladder cancer.
Also referred to as Nonsteroidal antiandrogen.
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 wants to see if giving bicalutamide together with standard BCG changes outcomes compared with BCG alone.
- Who it's for
- Adults who have non‑muscle invasive bladder cancer and are scheduled for intravesical BCG therapy.
- What's involved
- You will be randomly assigned to receive either standard BCG alone or BCG plus oral bicalutamide, with regular clinic visits and tests to monitor safety.
- Time commitment
- The trial follows the BCG induction schedule (about 6 weekly treatments) with visits during that period.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 36 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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, men only
You may be able to join if
- 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...
You likely can't join if
- 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...
- Patients who have uncontrolled hypertension (for our purposes, defined as those having a systolic blood pressure \> 160 documented on 2 occasions...
- Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal...
- Patients with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with systemic...
- 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...
See the full eligibility criteria
- 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.
- 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 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.
The study team makes the final eligibility decision.
Where it is enrolling
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Lévis, Quebec, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, 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 study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at London, Ontario, Canada; Toronto, Ontario, Canada; Lévis, Quebec, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada; Sherbrooke, 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.