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

Hormone-Refractory Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133704
• Other study ID #: D9902A
• 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

• Hormone-Refractory Prostate Cancer
• Prostatic Neoplasms

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