A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer

Non-Muscle Invasive Bladder Cancer Clinical Trial

— BicaBCa  

Official title:

A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327647
• Other study ID #: MP-20-2022-6318
• Status: Recruiting
• Phase: Phase 2
• Start date: June 23, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: CHU de Quebec-Universite Laval
• Contact: Paul Toren, MD,PhD,FRCSC
• Phone: 418-525-4444
• Email: paul.toren[@]crchudequebec.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2026
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males, age 18 or greater.

2. Patients with histologically confirmed non-muscle invasive urothelial carcinoma.

3. Patients have been recommended for a course of intravesical BCG induction treatment by their urologist

4. Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.

5. 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.

Exclusion Criteria:

1. Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrollment.

2. Patients who have received an induction course of intravesical chemotherapy within the last 5 years will be ineligible for enrollment.

3. 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 enrollment.

4. 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.

5. Patients with a history of venous thrombo-embolism (DVT/PE) within the past 3 years.

6. 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.

7. Patients with kidney disease with an estimated glomerular filtration rate (eGFR) < 30 will be ineligible.

8. Patients with neutropenia (< 3,000/µL) will be ineligible.

9. 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 will not be excluded.

10. Patients who have undergone treatment for any malignancy other than bladder cancer within the past 2 years except for superficial non-melanoma skin cancers.

11. Patients with prior history of prostate cancer treated by definitive local therapy > 5 years ago will only be eligible if they have had no clinical or biochemical evidence of recurrent prostate cancer.

12. Patients taking an investigational drug within 3 weeks of enrollment into this study.

13. Patients receiving or planning to receive coumadin therapy

Related Conditions & MeSH terms

• Non-Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Bicalutamide
Induction intravesical BCG with bicalutamide 150 mg for 90 days

Biological:
• Control Arm
Induction BCG

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of bladder tumour recurrence	To time to bladder tumor recurrence compared to the standard of care induction BCG	3 years
Secondary	Incidence of tumour progression	To compare the incidence of tumor progression between the intervention and control arms	3 years
Secondary	Number of tumor recurrences	To compare the overall incidence of tumor recurrences between intervention and control arms	3 years
Secondary	Number of tumours at first recurrence	Evaluation of the number of tumours at first recurrence between the two arms	3 years
Secondary	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	3 years
Secondary	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).	3 years