- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431391
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Homewood, Alabama, United States, 35209
- Urology Center of Alabama
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California
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La Jolla, California, United States, 91914
- University of California San Diego / Moores Cancer Center
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Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
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Los Angeles, California, United States, 90033
- Keck Hospital of USC
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Los Angeles, California, United States, 90033
- LAC + USC Medical Center
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Colorado
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Denver, Colorado, United States, 80211
- The Urology Center of Colorado
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Maryland
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Baltimore, Maryland, United States, 21287
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Nevada
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Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada
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New York
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Albany, New York, United States, 12206
- NYOH Albany Cancer Center at Patroon Creek
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Albany, New York, United States, 12208
- Community Care Physicians, PC
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Grand Strand Urology
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Texas
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San Antonio, Texas, United States, 78229
- Urology San Antonio Research
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Washington
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Seattle, Washington, United States, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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:
45.0 mg depot injection, 2 doses 6 months apart
Other Names:
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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.
|
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:
45.0 mg depot injection, 2 doses 6 months apart
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024
Time Frame: PA2024 ELISPOT counts at Month 24
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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.
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PA2024 ELISPOT counts at Month 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024
Time Frame: Month 24
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A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18
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Month 24
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Immunology
- Carcinoma
- Neoplasms
- Vaccine
- Immunotherapy
- Adenocarcinoma
- PSA
- Cancer vaccine
- Immune therapy
- Therapeutic vaccine
- Therapeutic cancer vaccine
- Dendritic cells
- Androgen deprivation therapy
- Prostatic Neoplasms
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Prostatic Diseases
- Androgens
- Hormones
- Neoplasms, Glandular and Epithelial
- Hormone therapy
- Luteinizing hormone-releasing hormone (LHRH)
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Male
- Prostatic Diseases
- Neoplasms
- Prostatic Neoplasms
- Adenocarcinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Leuprolide
Other Study ID Numbers
- P10-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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