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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01133704
Other study ID # D9902A
Secondary ID
Status Completed
Phase Phase 3
First received May 27, 2010
Last updated September 2, 2010
Start date May 2000
Est. completion date May 2005

Study information

Verified date September 2010
Source Dendreon
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date May 2005
Est. primary completion date March 2003
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
sipuleucel-T

APC-Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dendreon

Outcome

Type Measure Description Time frame Safety issue
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. from randomization to 36 months Yes
Secondary Overall Survival Subjects were followed for 3 years from the time of randomization or until death. Time from randomization until 36 months Yes
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