A Randomized Phase II Study of Androgen Deprivation Versus Combined With IMC-A12 Versus Androgen Deprivation Alone for Patients With New Hormone-Sensitive Metastatic Prostate Cancer
I. To compare the undetectable PSA rate (PSA < 0.2 ng/mL) after seven cycles (28 weeks) of
protocol treatment between those randomized to a LHRH agonist and bicalutamide and those
randomized to a LHRH agonist, bicalutamide and IMC-A12.
Secondary I. To assess the safety and tolerability of the combination of IMC-A12 with a LHRH
agonist and bicalutamide.
II. To compare the proportion of men who do not achieve a PSA of < 4 ng/mL between the two
III. To assess the accuracy of the prognostic model of undetectable PSA that was developed
from SWOG-9346 using current trial data from each arm.
IV. To assess serum samples and peripheral blood mononuclear cells (PBMNC) for
pharmacodynamic activity with potential biomarkers for IMC-A12 (including, but not limited
to: IGF-I, free IGF-I, IGF-II, IGFBP2, IGFBP3, Growth Hormone, insulin and C-peptide)
obtained from optional blood specimens both before initiation of androgen deprivation
therapy and twelve weeks after initiation of combined therapy.
V. To determine baseline pre-treatment circulating tumor cell (CTC) quantities and response
to therapy (for those patients with detectable CTC levels ≥ 1) twelve weeks later.
VI. In the same subset of patients where CTC levels are obtained, determine baseline serum
levels of microRNAs to include but not limited to mi-141 both before initiation of androgen
deprivation therapy and twelve weeks after combined therapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive androgen deprivation therapy comprising oral bicalutamide once daily
on days 1-28 and either goserelin subcutaneously or leuprolide acetate intramuscularly every
1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15.
Treatment repeats every 28 days for 7 courses in the absence of disease progression or
ARM II: Patients receive androgen deprivation therapy comprising bicalutamide and either
goserelin or leuprolide acetate as in arm I.
After completion of study therapy, patients are followed up every 6 months for 2 years and
then annually for 3 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Undetectable PSA rate
Southwest Oncology Group
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Tripler Army Medical Center||Honolulu, Hawaii 96859-5000|
|Genesys Hurley Cancer Institute||Flint, Michigan 48503|
|Virginia Mason CCOP||Seattle, Washington 98101|
|Evergreen Hospital Medical Center||Kirkland, Washington 98033|
|Spectrum Health Reed City Hospital||Reed City, Michigan 49677|
|Pacific Medical Center-First Hill||Seattle, Washington 98104|
|Fairbanks Memorial Hospital||Fairbanks, Alaska 99701|