Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

What Was Tested

This registered phase 3 trial tested Leuprolide.

It had two arms (groups): Arm I - Leuprolide + Flutamide (experimental) and Arm II - No Treatment (no intervention).

Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.

Arm II: Patients receive no initial treatment.

The registry classes the interventions as drug.

More on the Plan

OUTLINE: This is a randomized study.

Patients are randomized to one of two treatment arms. * Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. * Arm II: Patients receive no initial treatment.

Quality of life is assessed every 6 months for 5 years.

Quality of life of wives/partners of patients is assessed every 6 months for two years.

Who Took Part

64 actual participants took part.

It was open to men only.

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

Examples of who could join: Radical prostatectomy and bilateral lymph node dissection performed. Pathologic assessment of surgical specimens by MDACC pathologist. Radical prostatectomy performed within 90 days of enrollment and serum PSA level \< 0.1ng/ml. Written informed consent.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: any evidence of metastatic disease confirmed prior to enrollment; inability to confirm pathologic risk factors or inadequate prostatectomy (see item 4.1.5); failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to enrollment in study.

How the Study Was Run

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

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

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

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

It started in 1999-06-14 with completion listed for 2017-03-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Disease Free Survival at 5 Years (time frame: Beginning of the study up to 5 years).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 64 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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