Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
NeoACT
An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer
1 other identifier
interventional
42
1 country
7
Brief Summary
This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 prostate-cancer
Started Jul 2008
Typical duration for phase_2 prostate-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 11, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
April 1, 2015
CompletedMay 4, 2015
April 1, 2015
4.4 years
July 11, 2008
February 27, 2015
April 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.
Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Secondary Outcomes (8)
Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)
Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood
Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)
Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood
Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.
12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
- +3 more secondary outcomes
Study Arms (2)
Sipuleucel-T with Booster
EXPERIMENTALSubjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
Sipuleucel-T without Booster
EXPERIMENTALSubjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
Interventions
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dendreonlead
- University of California, San Franciscocollaborator
Study Sites (7)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115, United States
Kaiser Permanente Portland
Portland, Oregon, 97227, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98102, United States
Related Publications (1)
Sheikh N, Cham J, Zhang L, DeVries T, Letarte S, Pufnock J, Hamm D, Trager J, Fong L. Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects. Cancer Res. 2016 Jul 1;76(13):3711-8. doi: 10.1158/0008-5472.CAN-15-3173. Epub 2016 May 23.
PMID: 27216195DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lynn Ngo
- Organization
- Dendreon Corporation
Study Officials
- STUDY DIRECTOR
Andy Sandler, MD
Dendreon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2008
First Posted
July 15, 2008
Study Start
July 1, 2008
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
May 4, 2015
Results First Posted
April 1, 2015
Record last verified: 2015-04