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Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01431391
First received: August 5, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

The main purpose of this study is to determine whether ADT started before or after sipuleucel-T leads to a better immune system response. This study will also evaluate the safety of sipuleucel-T treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.


Condition Intervention Phase
Prostatic Neoplasm
Prostate Cancer
Prostatic Adenocarcinoma
Biological: sipuleucel-T
Drug: leuprolide acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Measure change in immune response to PA2024 by IFN-gamma production ELISPOT following sipuleucel-T/ADT treatment regimens. [ Time Frame: Change in immune response from baseline through Month 24 ] [ Designated as safety issue: No ]
    To determine whether ADT started before or after sipuleucel-T leads to superior augmentation of immune response to sipuleucel-T.


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: From baseline up to 3 years ] [ Designated as safety issue: Yes ]
  • Measure changes in immune responses over time [ Time Frame: From baseline through Month 24 ] [ Designated as safety issue: No ]
    Immune responses will be assessed from baseline through Month 24 by IFN-gamma ELISPOT assay, T cell proliferation assay, and production of antibodies (humoral response) to PAP and/or PA2024.

  • Measure changes in sipuleucel-T product parameters: CD54 upregulation, number of CD54+ cells, and total nucleated cell number [ Time Frame: Over the course of sipuleucel-T therapy (approximately 1 month) ] [ Designated as safety issue: No ]
    A course of sipuleucel-T therapy consists of 3 complete doses given at approximately 2-week intervals.

  • Measure changes in PSA over time [ Time Frame: From baseline through Month 27 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: sipuleucel-T followed by ADT
Beginning 2 weeks following the last sipuleucel-T infusion, subjects will receive one leuprolide acetate depot injection followed by a second injection 6 months later.
Biological: sipuleucel-T
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Other Names:
  • PROVENGE(R)
  • APC8015
Drug: leuprolide acetate
45.0 mg depot injection, 2 doses 6 months apart
Other Name: Eligard(R)
Experimental: Arm 2: ADT followed by sipuleucel-T
Beginning 12 weeks prior to the first sipuleucel-T infusion, subjects will receive one leuprolide acetate depot injection followed by a second injection 6 months later.
Biological: sipuleucel-T
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Other Names:
  • PROVENGE(R)
  • APC8015
Drug: leuprolide acetate
45.0 mg depot injection, 2 doses 6 months apart
Other Name: Eligard(R)

  Eligibility

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

Inclusion Criteria:

  • Histologically documented prostate cancer
  • Prior primary therapy for prostate cancer
  • Rising prostate specific antigen (PSA) with a PSA doubling time (PSADT) of ≤ 12 months
  • Non-metastatic disease with ECOG performance status ≤ 1
  • Testosterone ≥ 200 ng/dL ≤ 28 days of registration
  • Adequate hematologic, renal, and liver function
  • Must live in a permanent residence within a comfortable driving distance (roundtrip within one day) to the clinical research site

Exclusion Criteria:

  • Requires systemic ongoing immunosuppressive therapy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF
  • Prior sipuleucel-T therapy
  • Prior ADT therapy ≤ 6 months prior to registration or more than 6 months duration in total
  • Disease-free and off treatment for 10 years for other stage III/IV malignancies or 5 years for other stage I/II malignancies
  • Prior experimental immunotherapy within 1 year
  • Received denosumab or XRT ≤ 6 months prior to registration
  • Received chemotherapy or GM-CSF ≤ 90 days prior to registration
  • Received any of the following medications or interventions ≤ 28 days prior to registration

    • major surgery requiring general anesthesia
    • systemic immunosuppressive therapy
    • other prescription treatment for prostate cancer
  • Active infection within 1 week of registration
  • Likely to receive XRT or surgery for prostate cancer during the study period
  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: NCT01431391

Locations
United States, Alabama
Urology Center of Alabama
Homewood, Alabama, United States, 35209
United States, California
University of California San Diego / Moores Cancer Center
La Jolla, California, United States, 91914
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
LAC + USC Medical Center
Los Angeles, California, United States, 90033
Keck Hospital of USC
Los Angeles, California, United States, 90033
United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
Community Care Physicians, PC
Albany, New York, United States, 12208
NYOH Albany Cancer Center at Patroon Creek
Albany, New York, United States, 12206
United States, South Carolina
Grand Strand Urology
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Candice McCoy, MD Dendreon
  More Information

No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01431391     History of Changes
Other Study ID Numbers: P10-2
Study First Received: August 5, 2011
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dendreon:
immune therapy
cancer vaccine
therapeutic vaccine
therapeutic cancer vaccine
vaccine
dendritic cells
PSA
androgen deprivation therapy
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms
Prostatic Diseases
Androgens
Hormones
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
immunology
hormone therapy
immunotherapy
LHRH

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Androgens
Leuprolide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014