Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy

What Was Tested

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

This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy.

The study will investigate * Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone (ELIGARD®) * Immediate treatment following prostatectomy versus deferred treatment at the time of relapse Using a 2x2 factorial design participants will therefore be randomized to * Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) * Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy) * Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) * Deferred treatment with leuprolide acetate alone (hormonal therapy) Primary Objective: * The primary objective of the study is to compare progression-free survival using a 2x2 factorial design Secondary Objectives: * To compare the 5-year overall, cancer-specific and metastasis-free survival after systemic treatment between the groups * To compare the safety and tolerability between Docetaxel in combination with leuprolide acetate and leuprolide acetate alone. * To evaluate quality of life as measured by the FACT-P questionnaire.

Originally, 1696 participants were planned in the study (with 424 participants randomized to each arm).

It had four arms (groups): Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) (experimental), Leuprolide Acetate - Immediate Treatment (I-HT) (active comparator), Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) (experimental) and Leuprolide Acetate - Deferred Treatment (D-HT) (active comparator).

Participants administered docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months immediately following prostatectomy.

Participants administered leuprolide acetate every 3 months for 18 months immediately following prostatectomy.

Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months.

The registry classes the interventions as drug.

More on the Plan

Participants who did not progress before December 2010 were withdrawn from the study.

Who Took Part

228 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: Pathologically confirmed adenocarcinoma of the prostate based on central pathology review. All other variants are excluded. Randomization should occur less than 120 days after prostatectomy AND lymphadenectomy. Bone-scan without evidence of metastasis (within 6 months of randomization). Chest x-ray without evidence of metastasis (within 6 months of randomization). Abdominal computed tomography (CT) Scan without evidence of metastasis (within 6 months of randomization).

The full record lists 19 inclusion and 16 exclusion criteria; among the exclusions: prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy; prior radiation therapy; participants who received, are receiving or scheduled to receive post-operative radiotherapy.

How the Study Was Run

The set-up was randomized, factorial and open-label.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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

It started in 2005-12 with completion listed for 2010-12.

It ran at 17 sites in United States (1), Australia (1), Austria (1), Brazil (1), Canada (1) and France (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression (time frame: from the date of surgery up to 3 years after randomization of the last participant).

It also tracked 5 secondary outcomes, for example Median Overall Survival (OS), Median Cancer-specific Survival (CSS), Median Metastasis-free Survival (MFS), To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire and Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 228 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.