Advanced Prostate Cancer, Prostatic Neoplasms
Conditions
Brief summary
The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.
Detailed description
Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.
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
COHORT
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 advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment * subjects must understand and sign an informed consent form
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects | Every 3 months for a minimum of 3 years | The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Every 3 months for a minimum of 3 years | To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method. |
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. | 1,902 |
| Total | 1,902 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 1,223 |
| Overall Study | Lost to Follow-up | 58 |
| Overall Study | No discontinuation documentation | 41 |
| Overall Study | Study Termination | 3 |
| Overall Study | Unspecified reasons | 104 |
| Overall Study | Withdrawal by Subject | 88 |
Baseline characteristics
| Characteristic | Sipuleucel-T |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1461 Participants |
| Age, Categorical Between 18 and 65 years | 441 Participants |
| Age, Continuous | 71.9 Years |
| Alkaline phosphatase | 117.8 U/L STANDARD_DEVIATION 163.2 |
| Comorbidity Score High | 220 Participants |
| Comorbidity Score Low | 1682 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0=Fully Active; No restrictions | 1265 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1= Restricted Strenuous Activity | 571 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 2= Capable of selfcare | 34 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 3= Capable of limited selfcare | 8 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG Not Reported | 24 Participants |
| Gleason Sum Reported Gleason Score ≤7 | 790 Participants |
| Gleason Sum Reported Gleason Score ≥8 | 963 Participants |
| Gleason Sum Reported Gleson Sum Data Not Recorded | 149 Participants |
| Height | 176.59 Centimeters STANDARD_DEVIATION 7.29 |
| Hemoglobin | 12.68 g/dL STANDARD_DEVIATION 1.48 |
| Lactate dehydrogenase | 225.1 U/L STANDARD_DEVIATION 211.6 |
| Primary Gleason Score Gleason Score ≤3 | 486 Participants |
| Primary Gleason Score Gleason Score ≥4 | 1145 Participants |
| Primary Gleason Score Primary Gleason Score Data Not Recorded | 271 Participants |
| Prostate-specific antigen (PSA) | 71.93 ng/mL STANDARD_DEVIATION 287.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 22 Participants |
| Race (NIH/OMB) Black or African American | 221 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1649 Participants |
| Region of Enrollment United States | 1902 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1902 Participants |
| Weight | 91.97 kilogram STANDARD_DEVIATION 17.67 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1,223 / 1,976 |
| other Total, other adverse events | 12 / 1,902 |
| serious Total, serious adverse events | 260 / 1,902 |
Outcome results
Primary
To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects
The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.
Time frame: Every 3 months for a minimum of 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sipuleucel-T | To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects | 1.2 events per 100 patient years |
Secondary
Survival
To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.
Time frame: Every 3 months for a minimum of 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sipuleucel-T | Survival | 30.7 months |