Castration-Resistant Prostate Cancer
Conditions
Brief summary
The primary purpose of this research is to describe patient characteristics predictive of an imaging study positive for distant metastases in patients with castration-resistant prostate cancer and no known distant metastases.
Interventions
None listed
Sponsors
Dendreon
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent obtained prior to the initiation of study procedures. * Men ≥ 18 years of age. * Histologically documented prostatic adenocarcinoma. * History of Castration-Resistant Prostate Cancer.
Exclusion criteria
* Known M1 disease. * Undergone imaging study for metastatic prostate cancer ≤ 3 months. * ECOG performance status ≥ 3. * Known malignant pleural effusions or ascites. * Current or prior treatment with investigational therapy for M0 Castration-Resistant Prostate Cancer (Taxotere (docetaxel), Provenge® (sipuleucel-T), Zytiga (abiraterone acetate), Xtandi (enzalutamide), Jevtana (cabazitaxel), or Xofigo (radium Ra 223 dichloride).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration | Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sipuleucel-T A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer | 225 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 36 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | No data available | 2 |
| Overall Study | No Discontinuation Documentation | 37 |
| Overall Study | Study Termination | 100 |
| Overall Study | Withdrawal by Subject | 40 |
Baseline characteristics
| Characteristic | Sipuleucel-T |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 205 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous Total | 77.2 Years STANDARD_DEVIATION 8.8 |
| Body Mass Index | 30.2 kg/m^2 STANDARD_DEVIATION 6.2 |
| Height | 175.3 Centemeters STANDARD_DEVIATION 8.3 |
| Race (NIH/OMB) Total American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Total Asian | 0 Participants |
| Race (NIH/OMB) Total Black or African American | 51 Participants |
| Race (NIH/OMB) Total More than one race | 0 Participants |
| Race (NIH/OMB) Total Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Total Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Total White | 173 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 225 Participants |
| Weight | 92.7 Kg STANDARD_DEVIATION 20.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M0- No Distant Metastases | Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration | 10.9 years | Standard Deviation 6.4 |
| M1-Distant Metastases | Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration | 8.8 years | Standard Deviation 5.9 |