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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01431391
First received: August 5, 2011
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT 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
Intervention Model: Parallel Assignment
Masking: None (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:
  • Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024 [ Time Frame: PA2024 ELISPOT counts at Month 24 ]
    Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.


Secondary Outcome Measures:
  • Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024 [ Time Frame: Month 24 ]
    A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18


Enrollment: 68
Study Start Date: September 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Sipuleucel-T followed by ADT
Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Other Names:
  • PROVENGE®
  • APC8015
Drug: leuprolide acetate
45.0 mg depot injection, 2 doses 6 months apart
Other Name: Eligard®
Experimental: Arm 2: ADT followed by sipuleucel-T
Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Other Names:
  • PROVENGE®
  • APC8015
Drug: leuprolide acetate
45.0 mg depot injection, 2 doses 6 months apart
Other Name: Eligard®

Detailed Description:

Multicenter, randomized, open-label study, with subjects allocated (1:1) to 1 of 2 study arms, using a stratified randomization based on:

• Prostate-specific antigen doubling time (PSADT): ≤ 3 months or > 3 months and ≤ 12 months. • Primary therapy: radical prostatectomy (RP) or radiation, including brachytherapy, (XRT) or RP + XRT.

Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.

Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.

Cellular and humoral immune responses were assessed for Arm 2 subjects at 12, 8, and 4 weeks pre infusion 1, and in all subjects (both arms) at pre-leukapheresis 1, 2, and 3, and post-infusion 1, 2 and 3, and at the following time points after the third infusion: Weeks 2, 6, and 12 and Months 6, 9, 12, 15, 18, 21, and 24.

Safety assessments included adverse event (AE) monitoring, laboratory tests (complete blood count (CBC) and serum chemistry), vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, as well PSA and testosterone monitoring. The study was complete at the 27-Month visit for Arm 1 and the 24-Month visit for Arm 2.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hormone-sensitive prostate cancer
  • Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis
  • ECOG performance status ≤ 1
  • Histologically documented prostate cancer
  • Prior primary therapy for prostate cancer
  • Rising PSA with a PSADT of ≤ 12 months
  • 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 (round-trip 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 ≥ 6 months duration in total
  • If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years.
  • Prior experimental immunotherapy or on an experimental clinical trial 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
  • Any medical intervention, any other condition, or any circumstances that could compromise the study.
  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
Keck Hospital of USC
Los Angeles, California, United States, 90033
LAC + USC Medical Center
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
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
NYOH Albany Cancer Center at Patroon Creek
Albany, New York, United States, 12206
Community Care Physicians, PC
Albany, New York, United States, 12208
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
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
  More Information

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01431391     History of Changes
Other Study ID Numbers: P10-2
Study First Received: August 5, 2011
Results First Received: January 5, 2017
Last Updated: April 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Luteinizing hormone-releasing hormone (LHRH)

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

ClinicalTrials.gov processed this record on August 17, 2017