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.
Brief Title
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hormone-Refractory Prostate Cancer
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
Male
Gender Based
false
Keywords
asymptomatic metastatic hormone-refractory prostate cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01133704
Org Class
Industry
Org Full Name
Dendreon
Org Study Id
D9902A
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Primary Outcomes
Outcome Description
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.
Outcome Measure
Overall Time to Disease Progression
Outcome Time Frame
from randomization to 36 months
Secondary Outcomes
Outcome Description
Subjects were followed for 3 years from the time of randomization or until death.
Outcome Time Frame
Time from randomization until 36 months
Outcome Measure
Overall Survival
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
CPDMU_PI Kaufman
Investigator Email
Investigator Phone