Trial Outcomes & Findings for Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases (NCT NCT02758132)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Prior to Registration, Registration, Day 1 of cycle 4 and 13

Results posted on

2019-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Alliance A031201 Denosumab plus enzalutamide, abiraterone and prednisone Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity. Enzalutamide: 160 mg enzalutamide by mouth daily Abiraterone: 1000 mg abiraterone by mouth daily Prednisone: 5 mg prednisone by mouth twice daily	Standard of Care Denosumab plus enzalutamide alone Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity. Enzalutamide: 160 mg enzalutamide by mouth daily
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alliance A031201 Denosumab plus enzalutamide, abiraterone and prednisone Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity. Enzalutamide: 160 mg enzalutamide by mouth daily Abiraterone: 1000 mg abiraterone by mouth daily Prednisone: 5 mg prednisone by mouth twice daily	Standard of Care n=1 Participants Denosumab plus enzalutamide alone Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity. Enzalutamide: 160 mg enzalutamide by mouth daily	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to Registration, Registration, Day 1 of cycle 4 and 13

Population: Patient expired before completing study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment

Population: Patient expired before completing study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment

Population: Patient expired before completing study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment

Population: Patient expired before completing study

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to Registration, Day 1 of cycle 4 and 13, Post-Treatment Follow-up (up to 5 years post treatment)

Population: one subject enrolled and they discontinued early from trial, no analysis conducted

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment

Population: one subject enrolled and they discontinued early from trial, no analysis conducted

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to Registration, Registration, Day 1 of cycle 4 and 13

Population: one subject enrolled and they discontinued early from trial, no analysis conducted

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to Registration, Registration, Day 1 of cycle 4 and 13

Population: one subject enrolled and they discontinued early from trial, no analysis conducted

Outcome measures

Outcome data not reported

Adverse Events

Alliance A031201

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Alliance A031201 Denosumab plus enzalutamide, abiraterone and prednisone Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity. Enzalutamide: 160 mg enzalutamide by mouth daily Abiraterone: 1000 mg abiraterone by mouth daily Prednisone: 5 mg prednisone by mouth twice daily	Standard of Care n=1 participants at risk Denosumab plus enzalutamide alone Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity. Enzalutamide: 160 mg enzalutamide by mouth daily
Nervous system disorders intracranial hemorrhage	— 0/0 • Adverse events were captured over 6 months adverse event collection performed by standard collection practices, medical chart review, disclosure from subject	100.0% 1/1 • Number of events 1 • Adverse events were captured over 6 months adverse event collection performed by standard collection practices, medical chart review, disclosure from subject

Other adverse events

Adverse event data not reported

Additional Information

Stacy Mercado

University of Hawaii Cancer Center

Phone: 8084404561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place