Trial Outcomes & Findings for Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer (NCT NCT01981109)
NCT ID: NCT01981109
Last Updated: 2019-08-28
Results Overview
The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease.
TERMINATED
225 participants
Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.
2019-08-28
Participant Flow
Participant milestones
| Measure |
Sipuleucel-T
A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
|
|---|---|
|
Overall Study
STARTED
|
225
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
224
|
Reasons for withdrawal
| Measure |
Sipuleucel-T
A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
|
|---|---|
|
Overall Study
Death
|
36
|
|
Overall Study
Withdrawal by Subject
|
40
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
No Discontinuation Documentation
|
37
|
|
Overall Study
Study Termination
|
100
|
|
Overall Study
No data available
|
2
|
Baseline Characteristics
Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Sipuleucel-T
n=225 Participants
A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
205 Participants
n=5 Participants
|
|
Age, Continuous
Total
|
77.2 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
225 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Total · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Total · Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Total · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Total · Black or African American
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Total · White
|
173 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Total · More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Total · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Height
|
175.3 Centemeters
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Weight
|
92.7 Kg
STANDARD_DEVIATION 20.1 • n=5 Participants
|
|
Body Mass Index
|
30.2 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.Population: There were 206 patients at baseline that had a valuable data that were assessed. The results were 151 patients that had non-metastatic (M0) and 55 patients that had metastatic disease (M1) disease. The study terminated early therefore no further statistical analysis was performed.
The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease.
Outcome measures
| Measure |
M0- No Distant Metastases
n=151 Participants
A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
|
M1-Distant Metastases
n=55 Participants
A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer
|
|---|---|---|
|
Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration
|
10.9 years
Standard Deviation 6.4
|
8.8 years
Standard Deviation 5.9
|
Adverse Events
Sipuleucel-T
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
- Publication restrictions are in place
Restriction type: OTHER