Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT01431391 |
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Recruitment Status :
Completed
First Posted : September 9, 2011
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostatic Neoplasm Prostate Cancer Prostatic Adenocarcinoma | Biological: sipuleucel-T Drug: leuprolide acetate | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 68 participants |
| 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 |
| Study Start Date : | September 2011 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
Drug: leuprolide acetate 45.0 mg depot injection, 2 doses 6 months apart
Other Name: Eligard® |
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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.
|
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:
Drug: leuprolide acetate 45.0 mg depot injection, 2 doses 6 months apart
Other Name: Eligard® |
- 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.
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431391
| 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 | |
| Study Director: | Robert Israel, MD | Valeant Pharmaceuticals North America LLC |
| Responsible Party: | Dendreon |
| ClinicalTrials.gov Identifier: | NCT01431391 |
| Other Study ID Numbers: |
P10-2 |
| First Posted: | September 9, 2011 Key Record Dates |
| Results First Posted: | May 30, 2017 |
| Last Update Posted: | May 30, 2017 |
| Last Verified: | April 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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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) |
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Prostatic Neoplasms Neoplasms Adenocarcinoma Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Leuprolide Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |