Status:
COMPLETED
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
Lead Sponsor:
Dendreon
Conditions:
Prostatic Neoplasm
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT tr...
Detailed Description
Multicenter, randomized, open-label study, with subjects allocated (1:1) to 1 of 2 study arms, using a stratified randomization based on: • Prostate-specific antigen doubling time (PSADT): ≤ 3 months...
Eligibility Criteria
Inclusion
- Hormone-sensitive prostate cancer
- Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis
- ECOG performance status ≤ 1
- Histologically documented prostate cancer
- Prior primary therapy for prostate cancer
- Rising PSA with a PSADT of ≤ 12 months
- 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 (round-trip within one day) to the clinical research site
Exclusion
- 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 ≥ 6 months duration in total
- If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years.
- Prior experimental immunotherapy or on an experimental clinical trial 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
- Any medical intervention, any other condition, or any circumstances that could compromise the study.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01431391
Start Date
September 1 2011
End Date
December 1 2014
Last Update
May 30 2017
Active Locations (14)
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1
Urology Center of Alabama
Homewood, Alabama, United States, 35209
2
University of California San Diego / Moores Cancer Center
La Jolla, California, United States, 91914
3
Keck Hospital of USC
Los Angeles, California, United States, 90033
4
LAC + USC Medical Center
Los Angeles, California, United States, 90033