Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2016 by Dendreon
Sponsor:
Dendreon
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01727154
First received: November 12, 2012
Last updated: April 21, 2016
Last verified: April 2016
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Purpose
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Biological: Sipuleucel-T |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
Drug Information available for:
Sipuleucel-T
U.S. FDA Resources
Further study details as provided by Dendreon:
Primary Outcome Measures:
- To evaluate the immune response following sipuleucel-T therapy for all subjects [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]To evaluate the immune response following sipuleucel-T therapy for all subjects
Biospecimen Retention: Samples With DNA
Whole blood, serum, manufacturing samples
| Estimated Enrollment: | 350 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | January 2022 |
| Estimated Primary Completion Date: | January 2022 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Sipuleucel-T |
Biological: 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.
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- Subjects must be at least 18 years of age
- Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
- Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
- Subjects must understand and sign an informed consent form prior to their first leukapheresis
Exclusion Criteria:
•None
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727154
Show 59 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727154
Contacts
| Contact: Evett Oh | 949-436-9104 | eoh@dendreon.com | |
| Contact: Shabnam Vaziri | 206-455-2323 | svaziri@dendreon.com |
Show 59 Study Locations
Sponsors and Collaborators
Dendreon
Investigators
| Study Director: | Robert Israel, MD | Valeant Pharmaceuticals North America LLC |
More Information
| Responsible Party: | Dendreon |
| ClinicalTrials.gov Identifier: | NCT01727154 History of Changes |
| Other Study ID Numbers: | P11-4 |
| Study First Received: | November 12, 2012 |
| Last Updated: | April 21, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on September 23, 2016