Prostate Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
Detailed description
Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.
Interventions
BIOLOGICALSipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
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
* Subjects must be at least 18 years of age * Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT) * Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T * Subjects must understand and sign an informed consent form prior to their first leukapheresis
Exclusion criteria
•None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). | Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T. | The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sipuleucel-T Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. | 139 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 17 |
| Overall Study | No Discontinuation Documentation | 4 |
| Overall Study | Study Terminated | 6 |
| Overall Study | Subject Withdrew Consent | 18 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | Sipuleucel-T |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 106 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Age, Continuous | 71.8 Years STANDARD_DEVIATION 8.8 |
| Body Mass Index (BMI) | 28.8 kg/m^2 STANDARD_DEVIATION 5.6 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=0 | 89 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=1 | 34 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=2 | 4 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG=3 | 3 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Missing | 9 Participants |
| Gleason Sum Reported Gleson Sum<= 6 | 14 Participants |
| Gleason Sum Reported Gleson Sum=7 | 37 Participants |
| Gleason Sum Reported Gleson Sum>= 8 | 63 Participants |
| Gleason Sum Reported Missing | 25 Participants |
| Height | 177.6 Centemeters STANDARD_DEVIATION 6.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 115 Participants |
| Region of Enrollment United States | 139 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 139 Participants |
| Weight | 91.1 Kg STANDARD_DEVIATION 19.2 |
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
The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).
The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).
Time frame: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.
Population: This study was terminated early due to administrative reasons. A min of 200 patients were needed to obtain reliable data but only 139 were enrolled, 123 treated only 118 had analyzable immune response samples. Therefore this was a descriptive analysis of only 118pts with an immune response after dosing with Provenge. No comparative group available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sipuleucel-T | The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). | Subjects who had an immune response | 110 Participants |
| Sipuleucel-T | The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). | Subjects who did not have an immune response | 8 Participants |