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A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Hormone-Refractory Prostate Cancer

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Trial Information

A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Time to Disease Progression

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 Time Frame:

from randomization to 36 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

D9902A

NCT ID:

NCT01133704

Start Date:

May 2000

Completion Date:

May 2005

Related Keywords:

  • Hormone-Refractory Prostate Cancer
  • asymptomatic metastatic hormone-refractory prostate cancer
  • Prostatic Neoplasms

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