Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)
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ClinicalTrials.gov Identifier: NCT01727154 |
Recruitment Status :
Terminated
(Administrative reasons)
First Posted : November 15, 2012
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
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Condition or disease | Intervention/treatment |
---|---|
Prostate Cancer | Biological: Sipuleucel-T |
Study Type : | Observational |
Actual Enrollment : | 139 participants |
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 |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | July 2017 |
Actual Study Completion Date : | July 2017 |

Group/Cohort | Intervention/treatment |
---|---|
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:
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- 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). [ Time Frame: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-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).
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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): NCT01727154

Study Director: | Bruce Brown, MD | Dendreon Pharmaceuticals, LLC |
Documents provided by Dendreon:
Responsible Party: | Dendreon |
ClinicalTrials.gov Identifier: | NCT01727154 |
Other Study ID Numbers: |
P11-4 |
First Posted: | November 15, 2012 Key Record Dates |
Results First Posted: | August 19, 2019 |
Last Update Posted: | August 19, 2019 |
Last Verified: | July 2019 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |