Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

What Was Tested

This registered phase 4 trial tested Leuprolide and Goserelin.

This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex.

These drugs have been approved for treatment of Prostate Cancer by the FDA.

It had three arms (groups): Trelstar (experimental), Lupron (active comparator) and Zoladex (active comparator).

Per prescribing information.

Per prescribing information.

Per prescribing information.

The registry classes the interventions as drug.

More on the Plan

Patients who are currently receiving Lupron or Zoladex will be consented and then randomized to receive either continued treatment with the drug they have been on, or will be randomized to Trelstar for a period of 3 months.

Who Took Part

Enrollment: 41 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: Advanced Prostate Cancer. Currently taking Lupron or Zoladex. Baseline testosterone below castration level. Life expectancy \> 6 months. Eastern Cooperative Oncology Group performance status of 0-2.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: known hypersensitivity to any leuteinizing hormone releasing hormone (lhrh) agonist; ongoing therapy with hyperprolactinemic agents; antiandrogen therapy within 28 days prior to study start.

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.

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

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.

It started in 2002-09 with completion listed for 2006-05.

It ran at 11 sites in United States (11).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maintenance of serum testosterone at or below castration level (50ng/dL) (time frame: 12 weeks).

It also tracked 3 secondary outcomes, for example Serum testosterone level at end of study, Change in serum testosterone from baseline to end of study and Incidence and severity of adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide and Goserelin in 41 people.

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

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