Study of Effectiveness of IMC-A12 Antibody Combined With Hormone Therapy Prior to Surgery to Treat Prostate Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

It had 1 arm (groups): Experimental (experimental).

The registry classes the interventions as drug.

More on the Plan

These levels of androgen may continue to allow both survival of tumor cells and induction of resistance by overexpression of receptor.

The researchers propose to test this hypothesis in this phase II study, administering neoadjuvant androgen deprivation therapy IMC-A12 prior to radical prostatectomy for patients with clinically localized, high risk prostate cancer for 3 months.

Patients will undergo biopsy of the prostate prior to treatment and radical prostatectomy 12 weeks after initiation of treatment.

Who Took Part

Enrollment: 29 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: Good health and laboratory values within reasonable limits.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: patients with prostate cancer that has spread outside the prostate; patients who have low testosterone; patients who have received hormonal therapies or drugs which affect hormone metabolism.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-10 with completion listed for 2011-08.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The primary endpoint of the study is to determine the effects of combining androgen deprivation with IMC-A12 on pathologic tumor stage (pathologic complete response) (time frame: At the time of prostatectomy after 3 months of treatment).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Goserelin in 29 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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