Prostate Cancer Clinical Trial
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
Verified date | February 2015 |
Source | Dendreon |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Community Care Physicians, PC | Albany | New York |
United States | NYOH Albany Cancer Center at Patroon Creek | Albany | New York |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | The Urology Center of Colorado | Denver | Colorado |
United States | Urology Center of Alabama | Homewood | Alabama |
United States | University of California San Diego / Moores Cancer Center | La Jolla | California |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Keck Hospital of USC | Los Angeles | California |
United States | LAC + USC Medical Center | Los Angeles | California |
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
United States | Grand Strand Urology | Myrtle Beach | South Carolina |
United States | Urology San Antonio Research | San Antonio | Texas |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Dendreon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure change in immune response to PA2024 by IFN-gamma production ELISPOT following sipuleucel-T/ADT treatment regimens. | To determine whether ADT started before or after sipuleucel-T leads to superior augmentation of immune response to sipuleucel-T. | Change in immune response from baseline through Month 24 | No |
Secondary | Number of Participants with Adverse Events as a Measure of Safety | From baseline up to 3 years | Yes | |
Secondary | Measure changes in immune responses over time | 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. | From baseline through Month 24 | No |
Secondary | Measure changes in sipuleucel-T product parameters: CD54 upregulation, number of CD54+ cells, and total nucleated cell number | A course of sipuleucel-T therapy consists of 3 complete doses given at approximately 2-week intervals. | Over the course of sipuleucel-T therapy (approximately 1 month) | No |
Secondary | Measure changes in PSA over time | From baseline through Month 27 | No |
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