Pazopanib Hydrochloride After Leuprolide Acetate or Goserelin Acetate in Treating Patients With Relapsed Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin.

Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

It had two arms (groups): Pazopanib (experimental) and Observation (active comparator).

Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.

The registry classes the interventions as drug.

More on the Plan

Determine the adverse events in patients treated with this regimen.

To monitor for changes in testosterone in relationship to pazopanib therapy versus observation.

OUTLINE: Patients receive androgen blockade comprising GnRH agonist therapy (e.g., leuprolide acetate or goserelin acetate) for 6 months.

Patients who develop metastases or have PSA progression while on GnRH agonist therapy are removed from the study and placed on total androgen blockade.

Who Took Part

Enrollment: 37 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: Must be free of macrometastatic disease, as evidenced by computed tomography (CT) scan and bone scan, if serum PSA ≥ 10 ng/mL prior to GnRH agonist therapy. Progressive disease meeting the following criteria: NOTE: Patients who have undergone a prostatectomy and have two detectable, rising serum PSA levels are eligible. Two consecutive rises in PSA above nadir recorded after definite local therapy. Serum PSA concentrations must have absolute value of \> 0.5 ng/mL (separated by ≥ 2 weeks) prior to beginning GnRH agonist therapy. PSA \< 0.5 ng/mL.

The full record lists 62 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

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

It started in 2006-06 with completion listed for 2010-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Median Time to PSA Progression (time frame: Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment).

It also tracked 1 secondary outcome, for example Median PSA Progression-free Survival.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide and Goserelin in 37 people.

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

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.