Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
Status: | |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/16/2012 |
Start Date: | September 2011 |
End Date: | August 2014 |
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
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.
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
We found this trial at
14
sites
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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