Status:
COMPLETED
Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
Lead Sponsor:
Dendreon
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.
Detailed Description
This is a single center, open label, Phase 2 study. Subjects will be treated with 3 infusions of sipuleucel-T prior to a scheduled radical prostatectomy (RP) surgery. To assess the immune response fol...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00715104
Start Date
July 1 2008
End Date
December 1 2013
Last Update
May 4 2015
Active Locations (7)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
3
Kaiser Permanente Portland
Portland, Oregon, United States, 97227
4
Oregon Health & Science University
Portland, Oregon, United States, 97239