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Drug became available with insurance reimbursement
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This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen.
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen. The trial only involves the collection of additional blood samples for the purposes of monitoring immune response. These samples will be taken at 7 time points before, during and after patients receive Provenge® (Sipuleucel-T). There will be no other study-specific procedures performed (other than the blood draws) nor any use of investigational agents in this study.
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| Measure | Description | Time Frame |
|---|---|---|
| Immune Response | Standard of Care Drug Immune Response | Additional Blood Sample |
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Inclusion Criteria:
Patients who plan to receive standard of care Provenge® (Sipuleucel-T) at their primary physican's office.
Exclusion Criteria:
None
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Subjects that will be included in this study will be receiving Provenge as standard of care treatment for their prostate cancer and will be willing to consent to the additional blood draws.
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| Name | Affiliation | Role |
|---|---|---|
| John Nemunaitis, MD | Mary Crowley Cancer Research Centers | Principal Investigator |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |