Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer

What Was Tested

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

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

Treatment will be Abraxane/hormonal therapy (LHRH Agonist) for four nine-week cycles, followed by Total androgen blockade therapy (LHRH Agonist+ Anti-androgen) for 2 years from the time the hormonal therapy was started.

The registry classes the interventions as drug.

More on the Plan

Abraxane is a potent anticancer drug that stops cancer cells from growing and dividing by interfering with certain cell structures and killing the cancer cells.

Abraxane is the first albumin-bound taxane particle of approximately 130 nanometers that takes advantage of albumin, a natural carrier of water-insoluble molecules (e.g., various nutrients, vitamins, and hormones) found in humans.

Albumin is a protein that acts as the body's key transporter of nutrients and other water-insoluble molecules and selectively accumulates in tumor tissues.

The stage is set for chemotherapy/hormonal therapy to be given earlier in men with prostate cancer.

Who Took Part

Enrollment: 14 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: Histologic proof of adenocarcinoma of the prostate. Patients must be free of serious co-morbidity and have a life expectancy of ≥ 3 years.

The full record lists 8 inclusion and 4 exclusion criteria; among the exclusions: patients must not have a second malignancy unless there is confidence of previous curative therapy; patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection; patients must not have sensory neuropathy of grade 1 or greater.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2007-08 with completion listed for 2008-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 14 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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