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Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer (NeoACT)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sipuleucel-T with Booster
Sipuleucel-T without Booster
Sponsored by
Dendreon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 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.

Sites / Locations

  • USC / Norris Comprehensive Cancer Center
  • UCSF Comprehensive Cancer Center
  • Kaiser Permanente Portland
  • Oregon Health & Science University
  • University of Utah School of Medicine
  • Virginia Mason Medical Center
  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sipuleucel-T with Booster

Sipuleucel-T without Booster

Arm Description

Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.

Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood
Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) 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-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells.
Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood
Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.
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-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).
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-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.
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-γ) 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.
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-γ) 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.

Full Information

First Posted
July 11, 2008
Last Updated
April 14, 2015
Sponsor
Dendreon
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00715104
Brief Title
Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
Acronym
NeoACT
Official Title
An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dendreon
Collaborators
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sipuleucel-T with Booster
Arm Type
Experimental
Arm Description
Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
Arm Title
Sipuleucel-T without Booster
Arm Type
Experimental
Arm Description
Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
Intervention Type
Biological
Intervention Name(s)
Sipuleucel-T with Booster
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Sipuleucel-T without Booster
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Title
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
Description
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.
Time Frame
Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)
Title
Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood
Description
Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) 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-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells.
Time Frame
Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)
Title
Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood
Description
Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.
Time Frame
Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)
Title
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.
Description
The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).
Time Frame
12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Title
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.
Description
The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.
Time Frame
12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Title
Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups
Description
The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) 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.
Time Frame
12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Title
Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups
Description
The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) 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.
Time Frame
12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Sandler, MD
Organizational Affiliation
Dendreon
Official's Role
Study Director
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27216195
Citation
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.
Results Reference
derived
Links:
URL
http://www.pcacoalition.org
Description
National Prostate Cancer Coalition
URL
http://www.ustoo.org
Description
USTOO International

Learn more about this trial

Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer

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