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Prostate Cancer Clinical Trials

Sequencing of Sipuleucel-T and ADT for Non-metastatic Prostate Cancer
A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy
Status Conditions Phase Study ID
Closed Prostatic Neoplasm
Prostate Cancer
Prostatic Adenocarcinoma
Phase II NCT01431391
Summary

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.


Investigator
Evan Ya-Wen Yu, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
October 15, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.