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

Primary Purpose

Non-Muscle Invasive Bladder Cancer

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Bicalutamide

Control Arm

About this trial

This is an interventional treatment trial for Non-Muscle Invasive Bladder Cancer focused on measuring Bicalutamide, BCG instillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion 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.

Exclusion Criteria:

Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrollment.
Patients who have received an induction course of intravesical chemotherapy within the last 5 years will be ineligible for enrollment.
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.
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 venous thrombo-embolism (DVT/PE) within the past 3 years.
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 kidney disease with an estimated glomerular filtration rate (eGFR) < 30 will be ineligible.
Patients with neutropenia (< 3,000/μL) will be ineligible.
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.
Patients who have undergone treatment for any malignancy other than bladder cancer within the past 2 years except for superficial non-melanoma skin cancers.
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.
Patients taking an investigational drug within 3 weeks of enrollment into this study.
Patients receiving or planning to receive coumadin therapy

Sites / Locations

Centre Hospitalier de l'Université De Montréal_CHUMRecruiting
McGill University Health Centre_CUSMRecruiting
CHU de Québec-Université LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bicalutamide

Control Arm

Arm Description

Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days

Induction intravesical Bacille Calmette-Guérin treatment

Outcomes

Primary Outcome Measures

Rate of bladder tumour recurrence

To time to bladder tumor recurrence compared to the standard of care induction BCG

Secondary Outcome Measures

Incidence of tumour progression

To compare the incidence of tumor progression between the intervention and control arms

Number of tumor recurrences

To compare the overall incidence of tumor recurrences between intervention and control arms

Number of tumours at first recurrence

Evaluation of the number of tumours at first recurrence between the two arms

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

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).

Full Information

NCT ID

NCT05327647

First Posted

April 7, 2022

Last Updated

March 10, 2023

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT05327647

Brief Title

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

Acronym

BicaBCa

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 23, 2022 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Muscle Invasive Bladder Cancer

Keywords

Bicalutamide, BCG instillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bicalutamide

Arm Type

Experimental

Arm Description

Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days

Arm Title

Control Arm

Arm Type

Active Comparator

Arm Description

Induction intravesical Bacille Calmette-Guérin treatment

Intervention Type

Drug

Intervention Name(s)

Bicalutamide

Other Intervention Name(s)

Nonsteroidal antiandrogen

Intervention Description

Induction intravesical BCG with bicalutamide 150 mg for 90 days

Intervention Type

Biological

Intervention Name(s)

Control Arm

Intervention Description

Induction BCG

Primary Outcome Measure Information:

Title

Rate of bladder tumour recurrence

Description

To time to bladder tumor recurrence compared to the standard of care induction BCG

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Incidence of tumour progression

Description

To compare the incidence of tumor progression between the intervention and control arms

Time Frame

3 years

Title

Number of tumor recurrences

Description

To compare the overall incidence of tumor recurrences between intervention and control arms

Time Frame

3 years

Title

Number of tumours at first recurrence

Description

Evaluation of the number of tumours at first recurrence between the two arms

Time Frame

3 years

Title

Quality of life (QLQ-C30)

Description

Time Frame

3 years

Title

Evaluation of urinary symptoms

Description

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).

Time Frame

3 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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. Exclusion Criteria: Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrollment. Patients who have received an induction course of intravesical chemotherapy within the last 5 years will be ineligible for enrollment. 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. 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 venous thrombo-embolism (DVT/PE) within the past 3 years. 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 kidney disease with an estimated glomerular filtration rate (eGFR) < 30 will be ineligible. Patients with neutropenia (< 3,000/μL) will be ineligible. 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. Patients who have undergone treatment for any malignancy other than bladder cancer within the past 2 years except for superficial non-melanoma skin cancers. 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. Patients taking an investigational drug within 3 weeks of enrollment into this study. Patients receiving or planning to receive coumadin therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Toren, MD,PhD,FRCSC

Phone

418-525-4444

Ext

17064

paul.toren@crchudequebec.ulaval.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Toren, MD,PhD,FRCSC

Organizational Affiliation

CHU de Québec-Université Laval

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Wassim Kassouf, MDCM,FRCSC

Organizational Affiliation

McGill University Health Centre/Research Institute of the McGill University Health Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Melissa Huynh, MD,MPH,FRCSC

Organizational Affiliation

London Health Sciences Centre, Victoria Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jean-Baptiste Lattouf, MD,FRCSC

Organizational Affiliation

Centre Hospitalier Universitaire de Montréal (CHUM)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier de l'Université De Montréal_CHUM

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Baptiste Lattouf, MD

Facility Name

McGill University Health Centre_CUSM

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wassim Kassouf, MDCM

Phone

(514) 934-8246

wassim.kassouf.med@ssss.gouv.qc.ca

Facility Name

CHU de Québec-Université Laval

City

Québec

ZIP/Postal Code

G1G 5X1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Toren, MD

Phone

418-525-4444

Ext

17064

Paul.toren@crchudequebec.ulaval.ca

First Name & Middle Initial & Last Name & Degree

Typhaine Gris, PhD

Phone

418 525-4444

Ext

20417

typhaine.gris@crchudequebec.ulaval.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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