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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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).

Inclusion Criteria

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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the immune response within prostate tissue following neoadjuvant treatment with sipuleucel-T.

Outcome Time Frame:

baseline and at prostatectomy

Safety Issue:


Principal Investigator

Robert Sims, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Virginia Mason Medical Center Seattle, Washington  98111
UCSF Comprehensive Cancer Center San Francisco, California  94115
Seattle Cancer Care Alliance Seattle, Washington  98109
Oregon Health & Science University Portland, Oregon  97201
University of Utah School of Medicine Salt Lake City, Utah  84132
USC / Norris Comprehensive Cancer Center Los Angeles, California  90033
Kaiser Permanente Portland Portland, Oregon  97227