Trial Outcomes & Findings for Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel (NCT NCT02491411)
NCT ID: NCT02491411
Last Updated: 2018-07-12
Results Overview
PSA response rate is defined as the proportion of subjects with a \>= 50% PSA decline from baseline level when starting enzalutamide and maintained for \>= 4 weeks at any time-point after receiving enzalutamide. Will determine its corresponding 95% confidence interval.
TERMINATED
NA
5 participants
Up to 4 weeks post-treatment
2018-07-12
Participant Flow
One of the five patients enrolled, failed screen due to declining Eastern Cooperative Oncology Group (ECOG) Score of 3, and therefore could not start study.
Participant milestones
| Measure |
Treatment (Dexamethasone and Enzalutamide)
Patients receive dexamethasone PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until there is evidence of prostate specific antigen (PSA) progression, clinical disease progression, or radiographic disease progression. At time of progression, dexamethasone will be stopped via a rapid taper over one week if patients were treated for over 30 days. Patients then receive enzalutamide PO once daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of clinical disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Dexamethasone and Enzalutamide)
Patients receive dexamethasone PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until there is evidence of prostate specific antigen (PSA) progression, clinical disease progression, or radiographic disease progression. At time of progression, dexamethasone will be stopped via a rapid taper over one week if patients were treated for over 30 days. Patients then receive enzalutamide PO once daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of clinical disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel
Baseline characteristics by cohort
| Measure |
Treatment (Dexamethasone and Enzalutamide)
n=4 Participants
Patients receive dexamethasone PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until there is evidence of PSA progression, clinical disease progression, or radiographic disease progression. At time of progression, dexamethasone will be stopped via a rapid taper over one week if patients were treated for over 30 days. Patients then receive enzalutamide PO once daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of clinical disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks post-treatmentPopulation: Data was not collected, the study was terminated early due to lower enrollment.
PSA response rate is defined as the proportion of subjects with a \>= 50% PSA decline from baseline level when starting enzalutamide and maintained for \>= 4 weeks at any time-point after receiving enzalutamide. Will determine its corresponding 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 4 weeks post-treatmentPopulation: Data was not collected, the study was terminated early due to lower enrollment.
Summary statistics of the scores will be reported at baseline before starting dexamethasone and each follow-up time during the treatment of dexamethasone and enzalutamide. Changes in quality of life scores over the course of the study will be computed and their significance will be evaluated by paired-sample t-tests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeks post-treatmentPopulation: Data was not collected, the study was terminated early due to lower enrollment.
Will estimate 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Data was not collected, the study was terminated early due to lower enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Data was not collected, the study was terminated early due to lower enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeks post-treatmentPopulation: Data was not collected, the study was terminated early due to lower enrollment.
Will be summarized using Kaplan-Meier approach.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeks post-treatmentPopulation: Data was not collected, the study was terminated early due to lower enrollment.
Will be summarized using Kaplan-Meier approach.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Dexamethasone and Enzalutamide)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Dexamethasone and Enzalutamide)
n=4 participants at risk
Patients receive dexamethasone PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until there is evidence of PSA progression, clinical disease progression, or radiographic disease progression. At time of progression, dexamethasone will be stopped via a rapid taper over one week if patients were treated for over 30 days. Patients then receive enzalutamide PO once daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of clinical disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Endocrine disorders
cushingoid (increased appetite and weight )
|
50.0%
2/4 • Number of events 2 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
Nervous system disorders
insomnia
|
50.0%
2/4 • Number of events 2 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
Musculoskeletal and connective tissue disorders
left hand cramps
|
25.0%
1/4 • Number of events 1 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
Nervous system disorders
irritability
|
25.0%
1/4 • Number of events 1 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
General disorders
fatigue
|
50.0%
2/4 • Number of events 2 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
General disorders
abdominal pain
|
25.0%
1/4 • Number of events 1 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
25.0%
1/4 • Number of events 1 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
Skin and subcutaneous tissue disorders
BILATERAL LOWER EXTREMITIES EDEMA
|
25.0%
1/4 • Number of events 1 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
25.0%
1/4 • Number of events 1 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
Investigations
Paresthesia
|
25.0%
1/4 • Number of events 1 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
Musculoskeletal and connective tissue disorders
Right rib pain
|
25.0%
1/4 • Number of events 1 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
|
Eye disorders
Eye disorders (reddened eyes)
|
25.0%
1/4 • Number of events 1 • 4 weeks post treatment for each treatment cycle, up to 1 year
Every visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place