Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer

What Was Tested

The trial (phase 3) is built around Leuprolide.

It had two arms (groups): Combined Radiotherapy and Hormone Therapy (experimental) and Hormone Therapy alone (active comparator).

The registry classes the interventions as drug and radiation.

More on the Plan

The drug being tested in this study is called leuprorelin SR.

Leuprorelin SR is being tested to treat people who have prostate cancer.

This study will look at the overall survival of people who take leuprorelin SR in addition to radiation therapy compared to those who take only leuprorelin SR.

The study will enroll approximately 273 patients.

Who Took Part

Enrollment: 273 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: Patient in whom the prostatic adenocarcinoma has received no prior treatment of any type, with the possible exception of transurethral resection due to obstructive symptoms. Patient with a Karnofsky index greater than or equal to (≥) 70. Patient aged under 80 years on the randomization date. Patient with a life expectancy of at least 7 years. Patient who, after having received clear information, gave his written consent to participate and cooperate in the study.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: patient incapable of understanding the information supplied concerning the study or of giving his consent, or having refused to sign the informed consent form,; patient for whom there is a risk that follow-up in compliance with the conditions stipulated by the protocol will not be possible,; patient having already received prior treatment for prostate cancer, excluding transurethral resection of the prostate to relieve obstruction,.

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.

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

It started in 2000-03 with completion listed for 2008-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression-free survival at 5 years (time frame: Year 5).

It also tracked 7 secondary outcomes, for example Time to Biological Progression, Time to Clinical Progression, Overall Survival, Time to Locoregional Progression, Time to Onset of Metastatic Progression and Specific Survival.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 273 people.

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.