A Study of the Effect of Enantone LP [amount hidden] (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

It had two arms (groups): one (experimental) and Active surveillance (no intervention).

Active surveillance is close medical monitoring of prostate cancer for any changes.

The registry classes the interventions as drug.

More on the Plan

The drug being tested in this study is called leuprorelin.

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

Study assessments will include adverse events, prostatic-specific antigen (PSA) levels, and prostate biopsies.

The study will enroll approximately 120 patients.

Who Took Part

Enrollment: 116 actual participants took part.

It was open to men only aged from 50 years up to 80 years.

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

Examples of who could join: Is an out-patient 50 to 80 years old. Has read, understood, signed and dated the informed consent. Has indolent prostate cancer defined by:. Clinical Stage T1c or T2a. Biopsy cores of which at least 12 reveal the presence of positive cores and the absence of cores with tumor length \> 3 mm.

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: has psychological failure related to prostate cancer therapy; has any active disorder likely to affect the conduct of the study or the patient's prognosis during the study; has a mental deficiency or any other reason that may hinder the understanding or strict application of the protocol.

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.

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 2013-06-03 with completion listed for 2016-11-08.

It ran at 2 sites in France (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Negative Biopsies at Month 12 (time frame: Month 12).

It also tracked 7 secondary outcomes, for example Number of Participants With Gleason Score ≥ 7, Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score, Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI), Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI, Change From Baseline in Prostate-specific Antigen (PSA) Levels and Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 116 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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