Spots Global Cancer Trial Database for A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Official Title: A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Study ID: NCT05327647
Conditions
Study Description
Brief 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.
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 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 . The participation to this this trial should last 36 months from the screening visit to the last follow-up visit.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
London Health Sciences Centre, London, Ontario, Canada
Centre Hospitalier de l'Université De Montréal_CHUM, Montréal, Quebec, Canada
McGill University Health Centre_CUSM, Montréal, Quebec, Canada
CHU de Québec-Université Laval, Québec, , Canada
Contact Details
Name: Paul Toren, MD,PhD,FRCSC
Affiliation: CHU de Québec-Université Laval
Role: STUDY_CHAIR
Name: Wassim Kassouf, MDCM,FRCSC
Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Melissa Huynh, MD,MPH,FRCSC
Affiliation: London Health Sciences Centre, Victoria Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jean-Baptiste Lattouf, MD,FRCSC
Affiliation: Centre Hospitalier Universitaire de Montréal (CHUM)
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
