Trial Outcomes & Findings for Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (NCT NCT02685267)

Last Updated: 2021-04-09

Results Overview

The primary endpoint of the study is progression-free survival (PFS), defined as the time from randomization to disease progression. Progression will be evaluated using a combination of RECIST and Prostate Cancer Working Group 2 guidelines.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

1 year

Results posted on

2021-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Docetaxel/Prednisone Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout Docetaxel Prednisone	Docetaxel/Prednisone + Enzalutamide Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. Docetaxel Enzalutamide Prednisone
Overall Study STARTED	5	4
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel/Prednisone n=5 Participants Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout Docetaxel Prednisone	Docetaxel/Prednisone + Enzalutamide n=4 Participants Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. Docetaxel Enzalutamide Prednisone	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	68.2 years n=5 Participants	67.25 years n=7 Participants	67.78 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: As the study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm, the study was not evaluable for any efficacy endpoints. Sufficient data for the primary endpoint were not collected to provide outcome measures data tables below.

Outcome measures

Outcome measures
Measure	Docetaxel/Prednisone n=5 Participants Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout Docetaxel Prednisone	Docetaxel/Prednisone + Enzalutamide n=4 Participants Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. Docetaxel Enzalutamide Prednisone
Progression-free Survival (Radiographic or Per PCWG2 Criteria)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), Day 231, and every 21 days through study completion (an average of 1 year)

PSA response measured according to Prostate Cancer Working Group 2 (PCWG2). The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.

Outcome measures

Outcome measures
Measure	Docetaxel/Prednisone n=5 Participants Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout Docetaxel Prednisone	Docetaxel/Prednisone + Enzalutamide n=4 Participants Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. Docetaxel Enzalutamide Prednisone
PSA Response in the Standard Treatment Arm and Experimental Treatment Arm	2 Participants	3 Participants

SECONDARY outcome

Timeframe: At both 1 year and 2 years from treatment start

Outcome measures

Outcome measures
Measure	Docetaxel/Prednisone n=5 Participants Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout Docetaxel Prednisone	Docetaxel/Prednisone + Enzalutamide n=4 Participants Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. Docetaxel Enzalutamide Prednisone
Overall Survival	2 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), Day 231 and every 21 days through study completion (an average of 1 year)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), and every 63 days through study completion (an average of 1 year)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), and every 63 days through study completion (an average of 1 year)

Outcome measures

Outcome data not reported

Adverse Events

Docetaxel/Prednisone

Serious events: 2 serious events

Other events: 5 other events

Deaths: 3 deaths

Docetaxel/Prednisone + Enzalutamide

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel/Prednisone n=5 participants at risk Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout Docetaxel Prednisone	Docetaxel/Prednisone + Enzalutamide n=4 participants at risk Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. Docetaxel Enzalutamide Prednisone
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	20.0% 1/5 • Number of events 1 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Cardiac disorders Atrial fibrillation	20.0% 1/5 • Number of events 1 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose

Other adverse events

Additional Information

Jake Vinson

PCCTC

Phone: 646-422-4383

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Docetaxel/Prednisone n=5 participants at risk Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout Docetaxel Prednisone	Docetaxel/Prednisone + Enzalutamide n=4 participants at risk Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. Docetaxel Enzalutamide Prednisone
General disorders Fatigue	100.0% 5/5 • From treatment administration through 30 days after date of last dose	100.0% 4/4 • From treatment administration through 30 days after date of last dose
Gastrointestinal disorders Nausea	80.0% 4/5 • From treatment administration through 30 days after date of last dose	50.0% 2/4 • From treatment administration through 30 days after date of last dose
Skin and subcutaneous tissue disorders Alopecia	60.0% 3/5 • From treatment administration through 30 days after date of last dose	75.0% 3/4 • From treatment administration through 30 days after date of last dose
Metabolism and nutrition disorders Anorexia	80.0% 4/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Gastrointestinal disorders Vomiting	60.0% 3/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Nervous system disorders Peripheral sensory neuropathy	40.0% 2/5 • From treatment administration through 30 days after date of last dose	50.0% 2/4 • From treatment administration through 30 days after date of last dose
Nervous system disorders Peripheral motor neuropathy	40.0% 2/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Blood and lymphatic system disorders Anemia	20.0% 1/5 • From treatment administration through 30 days after date of last dose	50.0% 2/4 • From treatment administration through 30 days after date of last dose
Musculoskeletal and connective tissue disorders Myalgia	40.0% 2/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Gastrointestinal disorders Diarrhea	20.0% 1/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Gastrointestinal disorders Constipation	20.0% 1/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Skin and subcutaneous tissue disorders Nail discoloration	20.0% 1/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Gastrointestinal disorders Gastroesophageal reflux disease	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
General disorders Edema limbs	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Blood and lymphatic system disorders Edema limbs	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Nervous system disorders Dizziness	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Vascular disorders Hypotension	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Cardiac disorders Atrial fibrillation	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Blood and lymphatic system disorders White blood cell decreased	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Eye disorders Watering eyes	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Infections and infestations Upper respiratory infection	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Skin and subcutaneous tissue disorders Left great toe pain	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Gastrointestinal disorders Mucositis oral	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Respiratory, thoracic and mediastinal disorders Sore throat	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Nervous system disorders Headache	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Musculoskeletal and connective tissue disorders Generalized muscle weakness	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Respiratory, thoracic and mediastinal disorders Nasal congestion	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Blood and lymphatic system disorders Neutrophil count decreased	20.0% 1/5 • From treatment administration through 30 days after date of last dose	0.00% 0/4 • From treatment administration through 30 days after date of last dose
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Nervous system disorders Bell's Palsy	0.00% 0/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Psychiatric disorders Depression	0.00% 0/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Eye disorders Dry eye	0.00% 0/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Eye disorders Eye infection	0.00% 0/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Eye disorders Lacrimation	0.00% 0/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose
Skin and subcutaneous tissue disorders Nail pain	0.00% 0/5 • From treatment administration through 30 days after date of last dose	25.0% 1/4 • From treatment administration through 30 days after date of last dose