Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer

What Was Tested

The trial (phase 1, phase 2) is built around Leuprolide.

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Antihormone therapy, such as leuprolide, may lessen the amount of androgens made by the body.

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

The registry classes the interventions as drug and radiation.

More on the Plan

Secondary * Determine the 2-year biochemical progression-free survival of patients treated with this regimen.

Treatment repeats every 7 days for 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Who Took Part

The registry lists 23 actual participants took part.

It was open to men only aged from 18 years up to 120 years.

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

Examples of who could join: Histologically confirmed adenocarcinoma of the prostate with any of following clinical features:. No evidence of metastatic disease on chest x-ray, bone scan or CT scan of abdomen/pelvis. Age \> 18. The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Peripheral neuropathy: must be \< grade 1.

The full record lists 9 inclusion and 8 exclusion criteria; among the exclusions: documented metastases on staging studies; life expectancy \<10 years secondary to co-morbid illness; patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.

How the Study Was Run

The set-up was single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-08 with completion listed for 2010-06.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Biochemical Progression-free Survival (PFS).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Leuprolide in 23 people.

Its size is small, so on its own it can only give an early look.

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.