Phase 3
N=98
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Hormone-Refractory Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01133704 ↗Enrolled (actual)
98
Serious AEs
22.9%
Results posted
Sep 2010
Primary outcome: Primary: Overall Time to Disease Progression — 10.9; 9.9 Weeks — p=0.719
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sipuleucel-T (Biological); APC-Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Dendreon
- Primary completion
- Mar 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Time to Disease Progression |
10.9; 9.9 | 0.719 |
| SECONDARY Overall Survival |
19.0; 15.7 | 0.331 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01133704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.