Clinical Trial Details

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Study ID P10-2
Investigator
Candice McCoy, MD,   Dendreon
Title Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
Conditions Prostatic Neoplasm
Prostate Cancer
Prostatic Adenocarcinoma
Interventions Biological: sipuleucel-T
Drug: leuprolide acetate
Phase Phase 2
Purpose 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.
Eligibility 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
  • Study Location
    Community Care Physicians, PC
    Albany, New York, 12208
    Contact N/A

    Information objtained from ClinicalTrials.gov, on 10/31/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT01431391


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