Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

Key facts

Study ID

NCT00715104

Run by

Dendreon

People needed

42

Starts

2008-07-01

Expected to finish

2013-12-01

Last updated by the study team

2015-05-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adenocarcinoma of the prostate.
• Subject is scheduled for RP as the initial therapy for localized prostate cancer.
• Subject is ≥ 18 years of age.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subject has adequate hematologic, renal, and liver function.

You may not qualify if…

• Subject has any evidence of metastasis.
• Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
• Subject has received prior radiation therapy or chemotherapy for prostate cancer.
• Subject has received systemic steroid therapy within 14 days.
• Subject has a history of stage III or greater cancer, excluding prostate cancer.
• Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.
• Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCSF Comprehensive Cancer Center — San Francisco, California, United States
• Kaiser Permanente Portland — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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