Phase 3 Completed N=98 Randomized Quadruple-blind Treatment

Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

Hormone-Refractory Prostate Cancer

Source: ClinicalTrials.gov NCT01133704 ↗

Enrolled (actual)

Serious AEs

22.9%

Results posted

Sep 2010

Primary outcomePrimary: Overall Time to Disease Progression — 10.9; 9.9 Weeks — p=0.719

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.