Hormone-Refractory Prostate Cancer
Conditions
Keywords
asymptomatic metastatic hormone-refractory prostate cancer
Brief summary
This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.
Interventions
BIOLOGICALsipuleucel-T
BIOLOGICALAPC-Placebo
Sponsors
Dendreon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically documented adenocarcinoma of the prostate * Metastatic disease as evidenced by soft tissue and/or bony metastases * Prostate-specific antigen value of at least 5 ng/mL * Tumor progression while on hormonal therapy * Castration levels of testosterone (defined as less than 50 ng/dL) * Life expectancy of at least 16 weeks * Adequate hematologic, renal, and liver function
Exclusion criteria
* Visceral organ metastases * Metastatic disease expected to be in need of radiation therapy within 4 months. * Concurrent therapy with experimental agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Time to Disease Progression | from randomization to 36 months | Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Time from randomization until 36 months | Subjects were followed for 3 years from the time of randomization or until death. |
Participant flow
Recruitment details
Participants were randomized between May 2000 and March 2003 across 24 clinical trial sites.
Pre-assignment details
Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
Participants by arm
| Arm | Count |
|---|---|
| Sipuleucel-T (APC8015) All subjects randomized to receive sipuleucel-T.
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart. | 65 |
| Placebo All subjects randomized to receive placebo.
Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals. | 33 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 44 | 26 |
| Overall Study | Patient refused to continue | 4 | 0 |
| Overall Study | Study Closure | 1 | 0 |
Baseline characteristics
| Characteristic | Sipuleucel-T (APC8015) | Placebo | Total |
|---|---|---|---|
| Age Continuous | 69.6 years STANDARD_DEVIATION 8.2 | 70.6 years STANDARD_DEVIATION 7.8 | 69.9 years STANDARD_DEVIATION 8.1 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 65 Participants | 33 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 63 / 65 | 29 / 31 |
| serious Total, serious adverse events | 13 / 65 | 9 / 31 |
Outcome results
Primary
Overall Time to Disease Progression
Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.
Time frame: from randomization to 36 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sipuleucel-T (APC8015) | Overall Time to Disease Progression | 10.9 Weeks |
| Placebo | Overall Time to Disease Progression | 9.9 Weeks |
p-value: 0.71995% CI: [0.69, 1.7]Log Rank
Secondary
Overall Survival
Subjects were followed for 3 years from the time of randomization or until death.
Time frame: Time from randomization until 36 months
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sipuleucel-T (APC8015) | Overall Survival | 19.0 Months |
| Placebo | Overall Survival | 15.7 Months |
p-value: 0.33195% CI: [0.78, 2.07]Log Rank