Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer

Plain-language guide to NCT00116220: phase 3 randomized trial of Leuprolide and Goserelin, 206 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00116220
Phase: phase 3
Status: completed
Start: 1995-09
Completion (planned or actual): 2001-04
Participants: 206 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Prostate Cancer
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Leuprolide and Goserelin.

It had two arms (groups): Treatment 1 (active comparator) and Treatment 2 (active comparator).

External beam radiation therapy + 6 months total androgen ablation.

External beam radiation therapy.

The registry classes the interventions as drug and radiation.

More on the Plan

This was a randomized study comparing external beam radiation therapy with total androgen ablation for 6 months with radiation therapy alone.

Drugs were given 2 months prior, 2 months during, and 2 months after radiation therapy.

Eulexin and Lupron or Zoladex was used in this study.

Who Took Part

Enrollment: 206 actual participants took part.

It was open to men only aged from 41 years with no upper age limit.

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

Examples of who could join: Negative bone scan. Lymph nodes by CT or MRI. Adequate blood work. Performance Status - ECOG 0-1. Life expectancy of at least 10 years.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: prior history of malignancy; prior hormonal therapy or chemotherapy; prior pelvic radiation therapy.

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 1995-09 with completion listed for 2001-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Goserelin in 206 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 and the Goserelin compound page, all human trials.

Our Notes on the Compounds

Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.

Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.