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

Primary Purpose

Prostatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sipuleucel-T
leuprolide acetate
Sponsored by
Dendreon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasm focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology Center of Alabama
  • University of California San Diego / Moores Cancer Center
  • Keck Hospital of USC
  • LAC + USC Medical Center
  • USC / Norris Comprehensive Cancer Center
  • The Urology Center of Colorado
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Comprehensive Cancer Centers of Nevada
  • NYOH Albany Cancer Center at Patroon Creek
  • Community Care Physicians, PC
  • Grand Strand Urology
  • Urology San Antonio Research
  • Virginia Mason Medical Center
  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: Sipuleucel-T followed by ADT

Arm 2: ADT followed by sipuleucel-T

Arm Description

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.

Outcomes

Primary Outcome Measures

Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024
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
A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18

Full Information

First Posted
August 5, 2011
Last Updated
April 24, 2017
Sponsor
Dendreon
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1. Study Identification

Unique Protocol Identification Number
NCT01431391
Brief Title
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dendreon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Sipuleucel-T followed by ADT
Arm Type
Experimental
Arm Description
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 Title
Arm 2: ADT followed by sipuleucel-T
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
sipuleucel-T
Other Intervention Name(s)
PROVENGE®, APC8015
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
leuprolide acetate
Other Intervention Name(s)
Eligard®
Intervention Description
45.0 mg depot injection, 2 doses 6 months apart
Primary Outcome Measure Information:
Title
Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024
Description
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.
Time Frame
PA2024 ELISPOT counts at Month 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024
Description
A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18
Time Frame
Month 24

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Israel, MD
Organizational Affiliation
Valeant Pharmaceuticals North America LLC
Official's Role
Study Director
Facility Information:
Facility Name
Urology Center of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
University of California San Diego / Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
91914
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
LAC + USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
NYOH Albany Cancer Center at Patroon Creek
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Community Care Physicians, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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