Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer

Completed · Phase 2

Conditions studied: Prostatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma

In brief

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 treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.

Key facts

Study ID

NCT01431391

Run by

Dendreon

People needed

68

Starts

2011-09-01

Expected to finish

2014-12-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Urology Center of Alabama — Homewood, Alabama, United States
• University of California San Diego / Moores Cancer Center — La Jolla, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• LAC + USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• NYOH Albany Cancer Center at Patroon Creek — Albany, New York, United States
• Community Care Physicians, PC — Albany, New York, United States
• Grand Strand Urology — Myrtle Beach, South Carolina, United States
• Urology San Antonio Research — San Antonio, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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