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

This study has been completed.
University of California, San Francisco
Information provided by (Responsible Party):
Dendreon Identifier:
First received: July 11, 2008
Last updated: August 21, 2014
Last verified: August 2014

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
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group 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:
  • To assess the immune response within prostate tissue following neoadjuvant treatment with sipuleucel-T. [ Time Frame: baseline and at prostatectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other immunological or immunohistochemical tests will be evaluated [ Time Frame: estimated ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Biological: Sipuleucel-T
    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).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria

Eligible subjects must meet all of the following 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

A subject is not eligible for study participation if any of the following criteria apply.

  • 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.
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Please refer to this study by its identifier: NCT00715104

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

Additional Information:
No publications provided

Responsible Party: Dendreon Identifier: NCT00715104     History of Changes
Other Study ID Numbers: P07-1
Study First Received: July 11, 2008
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on August 21, 2014