A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD

What Was Tested

This registered phase 3 trial tested Leuprolide.

Phase IIIb, Open-label, randomized, controlled multi-centre study.

Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections.

Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months.

It had two arms (groups): Continuous Androgen Deprivation (CAD) (active comparator) and Intermittent Androgen Deprivation (IAD) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 706 actual participants took part.

It was open to men only aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written informed consent. Male subjects aged \>=18 and \<80 years old. Locally advanced (stage T3 or T4) prostate cancer or Relapsing prostate cancer following radical prostatectomy or,Relapsing prostate cancer following radiotherapy. Gleason score of \>=6. ECOG performance status of 0-2.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: any suspected second primary tumors; evidence of metastatic disease; other malignancy within the last 5 years except.

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.

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

It started in 2006-03 with completion listed for 2011-06.

It ran at 71 sites in France (17), Germany (10), Italy (10), Spain (9), Hungary (6) and Belgium (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to PSA progression (time frame: 3 Years).

It also tracked 5 secondary outcomes, for example Overall survival, World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status, European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25, Time to serum testosterone > 50 ng/dL and Change in progression biomarkers (some sites).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 706 people.

With 706 participants it is a large trial for this field.

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

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