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

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00715104
First received: July 11, 2008
Last updated: April 14, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Biological: Sipuleucel-T with Booster
Biological: Sipuleucel-T without Booster
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dendreon:

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 [ Time Frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T) ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP ] [ Designated as safety issue: No ]
    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.


Enrollment: 42
Study Start Date: July 2008
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sipuleucel-T with Booster
Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
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.
Experimental: Sipuleucel-T without Booster
Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
Biological: 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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715104

Locations
United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Oregon
Kaiser Permanente Portland
Portland, Oregon, United States, 97227
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98102
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Dendreon
University of California, San Francisco
Investigators
Study Director: Andy Sandler, MD Dendreon
  More Information

Additional Information:
No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00715104     History of Changes
Other Study ID Numbers: P07-1
Study First Received: July 11, 2008
Results First Received: February 27, 2015
Last Updated: April 14, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on August 30, 2015