A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease

What Was Tested

This registered phase 4 trial tested Leuprolide.

The purpose of this study is to investigate the effect of the study medication (Eligard®) on cancer markers (in the blood) of prostate cancer.

It had 1 arm (groups): Single Arm: Eligard (other).

Single Arm.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1 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: Confirmed metastatic prostate cancer for whom androgen deprivation therapy (ADT) is indicated. Serum PSA ≥ 5 ng/mL at screening. Eastern Cooperative Oncology Group (ECOG) score of 0-2. A life expectancy of at least 12 months. Is able to tolerate injection of study drug and comply with the study requirements.

The full record lists 7 inclusion and 24 exclusion criteria; among the exclusions: history of bilateral orchidectomy; history of any hormonal treatment/therapy with gnrh agonist, gnrh anti-agonist within 6 months of enrolment; any previous treatment with chemotherapy treatment for prostate cancer prior to the screening visit or within 6 months prior to screening for any other cancer.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Leuprolide 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 2014-08 with completion listed for 2015-08.

It ran at 3 sites in Netherlands (3).

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Changes from baseline of Testosterone levels in serum (time frame: Baseline to 6 months). Changes from baseline of PSA level in serum (time frame: Baseline to 6 months). Changes from baseline of PCA3 score in urine (time frame: Baseline to 6 months).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Leuprolide in 1 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.