Prostate Cancer
Conditions
Keywords
metastatic castrate resistant prostate cancer, prostate cancer, prostate, immune therapy, immunotherapy, vaccine, dendritic cells, antigen-presenting cells, antigen presenting cells, cancer vaccine, prostatic adenocarcinoma, Sipuleucel-T, castration resistant prostate cancer (CRPC), booster, retreatment, immune memory, immune response
Brief summary
Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.
Detailed description
Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases. During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone. Study Objectives: Primary: Evaluate the immune response generated by sipuleucel-T. Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.
Interventions
BIOLOGICALsipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Sponsors
Dendreon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T * Radiologic evidence of metastasis * Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease * Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration * Adequate hematologic function
Exclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status \> 2 * Treatment with chemotherapy within 3 months prior to registration * Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration * Treatment with commercial sipuleucel-T (Provenge®) * Current or imminent pathologic long-bone fracture or spinal cord compression * Known malignancies other than prostate cancer likely to require treatment within 6 months following registration * A requirement for systemic immunosuppressive therapy for any reason * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF * Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration * Any surgery requiring general anesthetic within 28 days prior to registration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants Enrolled and Treated Prior to Study Termination | Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015 | Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sipuleucel-T Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Study terminated | 4 |
Baseline characteristics
| Characteristic | Sipuleucel-T |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 74.4 years |
| Eastern Cooperative Oncology Group (ECOG) performance status ECOG 0=Fully Active; No restrictions | 6 Participants |
| Eastern Cooperative Oncology Group (ECOG) performance status ECOG 1= Restricted Strenuous Activity | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 8 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 8 |
| other Total, other adverse events | 8 / 8 |
| serious Total, serious adverse events | 2 / 8 |
Outcome results
Primary
Number of Study Participants Enrolled and Treated Prior to Study Termination
Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.
Time frame: Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015
Population: This study was terminated early due to administrative reasons. Only eight subjects out of the ninety subjects planned were enrolled and treated. Given the small number of patients enrolled, results should be interpreted with caution.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sipuleucel-T | Number of Study Participants Enrolled and Treated Prior to Study Termination | 8 Participants |