Trial Outcomes & Findings for Enzalutamide for Bladder Cancer Chemoprevention (NCT NCT02605863)

NCT ID: NCT02605863

Last Updated: 2018-10-03

Results Overview

Bladder cystoscopy, urine cytology, and pathology report

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-10-03

Participant Flow

Participant milestones

Measure	Intermediate Risk NMIBC Enzalutamide 160mg by mouth daily for 12 months Enzalutamide: 160 mg by mouth daily for 12 months	High Risk NMIBC Enzalutamide 160mg by mouth daily for 12 months Enzalutamide: 160 mg by mouth daily for 12 months
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enzalutamide for Bladder Cancer Chemoprevention

Baseline characteristics by cohort

Measure	Intermediate Risk NMIBC n=1 Participants Enzalutamide 160mg by mouth daily for 12 months Enzalutamide: 160 mg by mouth daily for 12 months	High Risk NMIBC Enzalutamide 160mg by mouth daily for 12 months Enzalutamide: 160 mg by mouth daily for 12 months	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	—	1 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 year

Population: There were no participants enrolled in the high risk arm.

Bladder cystoscopy, urine cytology, and pathology report

Outcome measures

Measure	Intermediate Risk NMIBC n=1 Participants Enzalutamide 160mg by mouth daily for 12 months Enzalutamide: 160 mg by mouth daily for 12 months	High Risk NMIBC Enzalutamide 160mg by mouth daily for 12 months Enzalutamide: 160 mg by mouth daily for 12 months
Number of Participants With Recurrent Disease	1 Participants	0 Participants

Adverse Events

Intermediate Risk NMIBC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

High Risk NMIBC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intermediate Risk NMIBC n=1 participants at risk Enzalutamide 160mg by mouth daily for 12 months Enzalutamide: 160 mg by mouth daily for 12 months	High Risk NMIBC Enzalutamide 160mg by mouth daily for 12 months Enzalutamide: 160 mg by mouth daily for 12 months
Gastrointestinal disorders vomiting	100.0% 1/1 • Number of events 1 • 1 year There were no participants enrolled in the high risk arm.	— 0/0 • 1 year There were no participants enrolled in the high risk arm.
Gastrointestinal disorders sore throat	100.0% 1/1 • Number of events 1 • 1 year There were no participants enrolled in the high risk arm.	— 0/0 • 1 year There were no participants enrolled in the high risk arm.
Respiratory, thoracic and mediastinal disorders cough	100.0% 1/1 • Number of events 1 • 1 year There were no participants enrolled in the high risk arm.	— 0/0 • 1 year There were no participants enrolled in the high risk arm.
Respiratory, thoracic and mediastinal disorders nasal congestion	100.0% 1/1 • Number of events 1 • 1 year There were no participants enrolled in the high risk arm.	— 0/0 • 1 year There were no participants enrolled in the high risk arm.
Respiratory, thoracic and mediastinal disorders rhinitis	100.0% 1/1 • Number of events 1 • 1 year There were no participants enrolled in the high risk arm.	— 0/0 • 1 year There were no participants enrolled in the high risk arm.
General disorders fatigue	100.0% 1/1 • Number of events 2 • 1 year There were no participants enrolled in the high risk arm.	— 0/0 • 1 year There were no participants enrolled in the high risk arm.

Additional Information

Edward Messing, ND

University of Rochester

Phone: 585-275-0998

Email: edward_messing@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place