Prostate Cancer
Conditions
Keywords
Androgen independent prostate cancer (AIPC), CRPC, prostate cancer, prostate, immune therapy, immunotherapy, vaccine, dendritic cells, antigen-presenting cells, antigen presenting cells, cancer vaccine, prostate specific antigen (PSA), prostatic adenocarcinoma
Brief summary
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
Detailed description
Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.
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
* Histologically documented adenocarcinoma of the prostate * Metastatic disease * Castrate resistant prostate cancer * Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration * Life expectancy of ≥ 3 months * Men ≥ 18 years of age * Adequate hematologic, renal and liver function
Exclusion criteria
* Presence of known lung, liver, or brain metastases * Evidence of neuroendocrine or small cell features * Eastern Cooperative Oncology Group (ECOG) performance status \> 2 * Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary) * Imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%) or spinal cord compression * Known malignancies other than prostate cancer that are likely to require treatment within six months of 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 granulocyte-macrophage colony-stimulating factor * Any infection requiring parenteral antibiotic therapy or causing fever (temp \> 100.5F or \> 38.1C) within 1 week prior to registration * Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives Treatment with any of the following medications or interventions within 28 days of registration: * Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans * Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide) * External beam radiation therapy or major surgery requiring general anesthetic * Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary * Chemotherapy * Treatment with any other investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC) | Day 0 (first infusion) and up to 3 infusions at 2-week intervals |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sipuleucel-T Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions | 104 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 4 |
| Overall Study | Disease progression | 1 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Sipuleucel-T |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 73 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 69.2 years |
| Eastern Cooperative Oncology Group (ECOG) performance status ECOG 0=Fully Active; No restrictions. | 66 Participants |
| Eastern Cooperative Oncology Group (ECOG) performance status ECOG 1= Restricted Strenuous Activity | 35 Participants |
| Eastern Cooperative Oncology Group (ECOG) performance status ECOG 2=Ambulatory, capable of self-care; no work | 3 Participants |
| Gleason Score Gleason Score ≤ 6 | 16 Participants |
| Gleason Score Gleason Score = 7 | 35 Participants |
| Gleason Score Gleason Score ≥ 8 | 51 Participants |
| Gleason Score Gleason Score Missing | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 95 Participants |
| Region of Enrollment United States | 104 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 98 |
| other Total, other adverse events | 91 / 98 |
| serious Total, serious adverse events | 13 / 98 |
Outcome results
Primary
Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
Time frame: Day 0 (first infusion) and up to 3 infusions at 2-week intervals
Population: Participants who Received At least 1 Infusion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sipuleucel-T | Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC) | 98 participants |