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Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT01133704•Dendreon

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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

Key Dates

Start Date

May 1, 2000

Primary Completion Date

March 1, 2003

Completion Date

May 1, 2005

Last Updated

September 8, 2010

Enrollment

ACTUAL participants

Conditions

Hormone-Refractory Prostate Cancer

Interventions

sipuleucel-T

BIOLOGICAL

APC-Placebo

BIOLOGICAL

Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel

NCT00082134

Hormone-refractory Prostate Cancer

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TERMINATEDPHASE1/PHASE2

Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

NCT01020305

Prostate CancerProstatic Neoplasms+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel

Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy