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Study ID
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P10-2
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Investigator
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Candice McCoy, MD, Dendreon
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Title
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Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
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Conditions
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Prostatic Neoplasm
Prostate Cancer
Prostatic Adenocarcinoma
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Interventions
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Biological: sipuleucel-T
Drug: leuprolide acetate
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Phase
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Phase 2
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Purpose
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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.
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Eligibility
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Ages Eligible: 18 Years
Genders Eligible:
Male
Accepts Healthy Volunteers:
No
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
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Study Location
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University of California San Diego / Moores Cancer Center
La Jolla, California, 91914
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Contact
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N/A
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Information obtained from ClinicalTrials.gov, on
5/23/2013. For additional information about
this and other clinical trials,
visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier:
NCT01431391