Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin.

Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, may lessen the amount of androgens made by the body.

It had two arms (groups): Arm I (androgen deprivation and cixutumumab) (experimental) and Arm II (androgen deprivation therapy) (active comparator).

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM 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 unacceptable toxicity.

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

The registry classes the interventions as biological, drug and other.

More on the Plan

To compare the undetectable prostate-specific antigen (PSA) rate (PSA \< 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment between those randomized to a luteinizing hormone-releasing hormone (LHRH) agonist and bicalutamide and those randomized to a LHRH agonist, bicalutamide and IMC-A12 (cixutumumab).

To assess the safety and tolerability of the combination of IMC-A12 with a LHRH agonist and bicalutamide.

To compare the proportion of men who do not achieve a PSA of \< 4 ng/mL between the two groups.

To assess the accuracy of the prognostic model of undetectable PSA that was developed from Southwest Oncology Group (SWOG)-9346 using current trial data from each arm.

Who Took Part

211 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Visceral disease (liver, lung, or other viscera). Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton. Lymph node disease not considered to be encompassed within a single radiotherapy port (e.g., above the aortic bifurcation, etc.). Patients must have a PSA \>= 5 ng/mL obtained within 90 days prior to initiation of androgen deprivation therapy. Patients must not have received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionuclide therapy within 28 days prior to registration.

The full record lists 34 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2010-12 with completion listed for 2015-06.

It ran at 170 sites in United States (169) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Undetectable PSA Rate (time frame: 7 months).

It also tracked 6 secondary outcomes, for example Toxicity, Proportion of Patients Who do Not Achieve a Partial PSA Response, Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346), Correlation of microRNA Measures With 28-week PSA Response, Correlation of microRNA Measures With Baseline Circulating Tumor Cell (CTC) Counts and Change in Level of CTCs.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide and Goserelin in 211 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page and the Goserelin compound page, all human trials.