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Administrative reasons
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The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sipuleucel-T |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sipuleucel-T | Biological | Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). | The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T). | Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T. |
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Inclusion Criteria:
Exclusion Criteria:
•None
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Men at least 18 years of age with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT), and have not yet undergone leukapheresis for their first dose of sipuleucel-T.
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Brown, MD | Dendreon Pharmaceuticals, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 21st Century Oncology | Scottsdale | Arizona | 85251 | United States | ||
| Tower Urology / Tower Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sipuleucel-T | Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2013 |
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Whole blood, serum, manufacturing samples
|
| Los Angeles |
| California |
| 90048 |
| United States |
| Prostate Oncology Specialists, Inc. | Marina del Rey | California | 90292 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Howard University Cancer Center | Washington D.C. | District of Columbia | 20060 | United States |
| First Urology, PSC | Jeffersonville | Indiana | 47130 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Highland Clinic | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Michigan Institute of Urology | Troy | Michigan | 48084 | United States |
| St. Louis Cancer Care, LLP | Bridgeton | Missouri | 63044 | United States |
| St. Louis Cancer Care, LLP | St Louis | Missouri | 63127 | United States |
| Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052, 89014, 89074 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169, 89128, 98148 | United States |
| Delaware Valley Urology, LLC | Mount Laurel | New Jersey | 08054 | United States |
| National Translational Research Group, Inc. | East Setauket | New York | 11733 | United States |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | United States |
| Associated Medical Professionals of NY, PLLC | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Carolina Urology Partners | Gastonia | North Carolina | 28054 | United States |
| Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina | Raleigh | North Carolina | 27607 | United States |
| TriState Urologic Services PSC Inc., dba The Urology Group | Cincinnati | Ohio | 45212 | United States |
| Urologic Specialists of Oklahoma | Tulsa | Oklahoma | 74146 | United States |
| Providence Health & Services | Portland | Oregon | 97213 | United States |
| Oregon Urology Institute | Springfield | Oregon | 97477 | United States |
| Northwest Cancer Specialists, PC | Tualatin | Oregon | 97062 | United States |
| Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| South Carolina Oncology Associates | Columbia | South Carolina | 29210 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Urology Associates, P.C. | Nashville | Tennessee | 37209 | United States |
| Texas Oncology - Fort Worth | Fort Worth | Texas | 76104, 76132 | United States |
| Urology of Virginia, PLLC | Virginia Beach | Virginia | 23462 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States |
| University of Washington Medical Centerl | Seattle | Washington | 98195 | United States |
| Northwest Cancer Specialists | Vancouver | Washington | 98684, 98683 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sipuleucel-T | Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||||
| Height | Mean | Standard Deviation | Centemeters |
| |||||||||||||||||||
| Weight | Mean | Standard Deviation | Kg |
| |||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour;3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair;5=Dead | Count of Participants | Participants |
| |||||||||||||||||||
| Gleason Sum Reported | Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread. | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). | The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T). | This study was terminated early due to administrative reasons. A min of 200 patients were needed to obtain reliable data but only 139 were enrolled, 123 treated only 118 had analyzable immune response samples. Therefore this was a descriptive analysis of only 118pts with an immune response after dosing with Provenge. No comparative group available. | Posted | Count of Participants | Participants | Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T. |
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All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Reporting requirements for serious adverse events (SAEs) are described in the respective protocols (P10-3 and P12-1) for the trial in which each subject is concurrently enrolled.
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Reporting requirements for serious adverse events (SAEs) are described in the respective protocols (P10-3 and P12-1) for the trial in which each subject is concurrently enrolled.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sipuleucel-T | Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. | 0 | 0 | 0 | 0 | 0 | 0 |
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Early termination leading to small numbers of subjects analyzed as a minimum of 200 patients were needed to obtain reliable data; however only 123 were treated. Given the small number of patients enrolled, analyses do not provide reliable results.
The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shabnam Vaziri | Dendreon | 206.455.2323 | svaziri@Dendreon.com |
| Nov 9, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C511774 | sipuleucel-T |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| ECOG=2 |
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| ECOG=3 |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Gleson Sum>= 8 |
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| Missing |
|