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Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (Doce/Enza)

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ClinicalTrials.gov Identifier: NCT02685267
Recruitment Status : Terminated
First Posted : February 18, 2016
Results First Posted : March 12, 2021
Last Update Posted : April 9, 2021
Sponsor:
Collaborators:
University of Chicago
Astellas Pharma Inc
Information provided by (Responsible Party):
Prostate Cancer Clinical Trials Consortium

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Docetaxel
Drug: Enzalutamide
Drug: Prednisone
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Docetaxel/Prednisone Docetaxel/Prednisone + Enzalutamide
Hide Arm/Group Description

Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout

Docetaxel

Prednisone

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
Period Title: Overall Study
Started 5 4
Completed 5 4
Not Completed 0 0
Arm/Group Title Docetaxel/Prednisone Docetaxel/Prednisone + Enzalutamide Total
Hide Arm/Group Description

Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout

Docetaxel

Prednisone

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 of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  40.0%
2
  50.0%
4
  44.4%
>=65 years
3
  60.0%
2
  50.0%
5
  55.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
68.2
(55 to 84)
67.25
(58 to 79)
67.78
(55 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
4
 100.0%
9
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  40.0%
2
  50.0%
4
  44.4%
White
3
  60.0%
2
  50.0%
5
  55.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 4 participants 9 participants
5 4 9
1.Primary Outcome
Title Progression-free Survival (Radiographic or Per PCWG2 Criteria)
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title Docetaxel/Prednisone Docetaxel/Prednisone + Enzalutamide
Hide Arm/Group Description:

Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout

Docetaxel

Prednisone

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 Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel/Prednisone
Comments 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.
Type of Statistical Test Other
Comments 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.
Statistical Test of Hypothesis P-Value 0.6761
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter log-rank test
Estimated Value 0.6761
Estimation Comments [Not Specified]
2.Secondary Outcome
Title PSA Response in the Standard Treatment Arm and Experimental Treatment Arm
Hide Description

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.
Time Frame Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), Day 231, and every 21 days through study completion (an average of 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docetaxel/Prednisone Docetaxel/Prednisone + Enzalutamide
Hide Arm/Group Description:

Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout

Docetaxel

Prednisone

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 Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
3
  75.0%
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame At both 1 year and 2 years from treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docetaxel/Prednisone Docetaxel/Prednisone + Enzalutamide
Hide Arm/Group Description:

Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout

Docetaxel

Prednisone

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 Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
4
 100.0%
4.Other Pre-specified Outcome
Title Quality of Life (QOL)
Hide Description [Not Specified]
Time Frame 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 Measure Data Not Reported
5.Other Pre-specified Outcome
Title Circulating Tumor Cells (CTCs)
Hide Description [Not Specified]
Time Frame Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), and every 63 days through study completion (an average of 1 year)
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Analysis of Androgen Receptor Splice Variant
Hide Description [Not Specified]
Time Frame Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), and every 63 days through study completion (an average of 1 year)
Outcome Measure Data Not Reported
Time Frame From treatment administration through 30 days after date of last dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel/Prednisone Docetaxel/Prednisone + Enzalutamide
Hide Arm/Group Description

Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout

Docetaxel

Prednisone

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
All-Cause Mortality
Docetaxel/Prednisone Docetaxel/Prednisone + Enzalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   3/5 (60.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Docetaxel/Prednisone Docetaxel/Prednisone + Enzalutamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      0/4 (0.00%)    
Cardiac disorders     
Atrial fibrillation *  1/5 (20.00%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle weakness lower limb *  1/5 (20.00%)  1 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel/Prednisone Docetaxel/Prednisone + Enzalutamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders     
Anemia *  1/5 (20.00%)  2/4 (50.00%) 
Edema limbs *  1/5 (20.00%)  0/4 (0.00%) 
White blood cell decreased *  1/5 (20.00%)  0/4 (0.00%) 
Neutrophil count decreased *  1/5 (20.00%)  0/4 (0.00%) 
Cardiac disorders     
Atrial fibrillation *  1/5 (20.00%)  0/4 (0.00%) 
Eye disorders     
Watering eyes *  1/5 (20.00%)  0/4 (0.00%) 
Dry eye *  0/5 (0.00%)  1/4 (25.00%) 
Eye infection *  0/5 (0.00%)  1/4 (25.00%) 
Lacrimation *  0/5 (0.00%)  1/4 (25.00%) 
Gastrointestinal disorders     
Nausea *  4/5 (80.00%)  2/4 (50.00%) 
Vomiting *  3/5 (60.00%)  1/4 (25.00%) 
Diarrhea *  1/5 (20.00%)  1/4 (25.00%) 
Constipation *  1/5 (20.00%)  1/4 (25.00%) 
Gastroesophageal reflux disease *  1/5 (20.00%)  0/4 (0.00%) 
Abdominal pain *  1/5 (20.00%)  0/4 (0.00%) 
Mucositis oral *  1/5 (20.00%)  0/4 (0.00%) 
General disorders     
Fatigue *  5/5 (100.00%)  4/4 (100.00%) 
Edema limbs *  1/5 (20.00%)  0/4 (0.00%) 
Infections and infestations     
Upper respiratory infection *  1/5 (20.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders     
Anorexia *  4/5 (80.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia *  2/5 (40.00%)  0/4 (0.00%) 
Back pain *  1/5 (20.00%)  1/4 (25.00%) 
Muscle weakness lower limb *  1/5 (20.00%)  0/4 (0.00%) 
Generalized muscle weakness *  1/5 (20.00%)  0/4 (0.00%) 
Nervous system disorders     
Peripheral sensory neuropathy *  2/5 (40.00%)  2/4 (50.00%) 
Peripheral motor neuropathy *  2/5 (40.00%)  1/4 (25.00%) 
Dizziness *  1/5 (20.00%)  0/4 (0.00%) 
Headache *  1/5 (20.00%)  0/4 (0.00%) 
Bell's Palsy *  0/5 (0.00%)  1/4 (25.00%) 
Psychiatric disorders     
Depression *  0/5 (0.00%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough *  1/5 (20.00%)  0/4 (0.00%) 
Sore throat *  1/5 (20.00%)  0/4 (0.00%) 
Nasal congestion *  1/5 (20.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia *  3/5 (60.00%)  3/4 (75.00%) 
Nail discoloration *  1/5 (20.00%)  1/4 (25.00%) 
Dry skin *  1/5 (20.00%)  0/4 (0.00%) 
Left great toe pain *  1/5 (20.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders - Other, specify *  1/5 (20.00%)  0/4 (0.00%) 
Nail loss *  0/5 (0.00%)  1/4 (25.00%) 
Skin irritation *  0/5 (0.00%)  1/4 (25.00%) 
Nail pain *  0/5 (0.00%)  1/4 (25.00%) 
Vascular disorders     
Hypotension *  1/5 (20.00%)  0/4 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jake Vinson
Organization: PCCTC
Phone: 646-422-4383
EMail: vinsonj@mskcc.org
Layout table for additonal information
Responsible Party: Prostate Cancer Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT02685267    
Other Study ID Numbers: c13-126
First Submitted: February 9, 2016
First Posted: February 18, 2016
Results First Submitted: July 29, 2019
Results First Posted: March 12, 2021
Last Update Posted: April 9, 2021