Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer

Prostate Cancer Clinical Trial

— NeoACT  

Official title:

An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715104
• Other study ID #: P07-1
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2008
• Last updated: April 14, 2015
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Dendreon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel T. Following RP, subjects will be randomized to receive either a booster infusion of sipuleucel T or no further treatment with sipuleucel-T (i.e., booster: no booster).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Subject has any evidence of metastasis.

• Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 a-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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Sipuleucel-T with Booster
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 without Booster
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.

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	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	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Dendreon	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	CD4+ 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)	No
Secondary	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	CD8+ 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 following sipuleucel-T)	No
Secondary	Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood	Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-?) enzyme-linked immunospot (ELISPOT) assays.; This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150-7156.). The unit of analysis is the number of IFN-? ELISPOT counts per 300,000 peripheral blood mononuclear cells.	Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)	No
Secondary	Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood	Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-?) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.	Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)	No
Secondary	Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.	The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-?) enzyme-linked immunospot (ELISPOT) assays (memory T cells).	12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP	No
Secondary	Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.	The number of PAP-specific T cells was enumerated by interferon gamma (IFN-?) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.	12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP	No
Secondary	Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups	The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-?) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.	12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP	No
Secondary	Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups	The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-?) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.	12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP	No

External Links

•   Prostate Cancer Research Institute
•   USTOO International