Randomized Phase II Trial of Docetaxel With or Without PSA-TRICOM Vaccine in Patients With Castrate-Resistant Metastatic Prostate Cancer
I. To evaluate the overall survival in patients treated with PSA-TRICOM and docetaxel
chemotherapy versus docetaxel chemotherapy only.
I. To evaluate the time to radiographic progression after beginning docetaxel chemotherapy
in patients previously treated with PSA-TRICOM vaccine versus those not treated with this
II. To compare objective responses (according to RECIST) between the two treatment groups in
those patients with measurable disease.
III. To evaluate PSA response rates (decline > 50%) in patients treated with PSA-TRICOM and
docetaxel chemotherapy versus docetaxel chemotherapy only.
IV. To evaluate immune responses elicited in patients treated before and after docetaxel
V. To evaluate the association between development of prostate antigen-specific immune
responses and time to progression and overall survival.
VI. To evaluate the association of predicted survival (by Halabi nomogram) with actual
survival in patients treated with PSA-TRICOM vaccine versus those not treated with this
OUTLINE: This is a multicenter study. Patients are stratified according to disease
progression (PSA vs radiographic criteria), extraskeletal metastases (yes vs no), and prior
bisphosphonate (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I (vaccine and chemotherapy): Patients receive vaccinia-PSA(L155)-TRICOM vaccine
subcutaneously (SC) on day 1 of course 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15,
29, 43, and 57 of course 1. Beginning on day 85 (day 1 of course 2), patients receive
docetaxel intravenously (IV) over 1 hour on day 1 and prednisone orally (PO) twice daily on
days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12
courses in the absence of disease progression or unacceptable toxicity.
ARM II (chemotherapy): Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO
twice daily on days 1-21. Treatment repeats every 21 days for up to 12 courses in the
absence of disease progression or unacceptable toxicity.
Some patients undergo blood sample collection to measure frequency of PSA-specific T-cells
and other biomarkers of immune response.
After completion of study therapy, patients are followed up every 3-6 months for 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Median overall survival
The method of Kaplan and Meier will be used to characterize overall survival, and the stratified log-rank test will be used to compare this endpoint between treatment arms.
Up to 5 years
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|Mayo Clinic||Rochester, Minnesota 55905|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Ochsner Clinic Foundation||New Orleans, Louisiana 70121|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Hematology and Oncology Associates||Chicago, Illinois 60611|
|Hematology Oncology Associates of Illinois-Highland Park||Highland Park, Illinois 60035|
|Mayo Clinic in Florida||Jacksonville, Florida 32224|
|Northwestern University||Chicago, Illinois 60611|
|Provena Saint Mary's Hospital||Kankakee, Illinois 60901|
|North Shore Hematology Oncology||Libertyville, Illinois 60048|
|Hematology Oncology Associates of Illinois - Skokie||Skokie, Illinois 60076|
|New York University Langone Medical Center||New York, New York 10016|
|Illinois Cancer Specialists-Niles||Niles, Illinois 60714|