Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the second leading cause of cancer-related mortality.

More than 230,000 men will be diagnosed with prostate cancer in the USA this year and more than 30,000 will die of this disease.

It had three arms (groups): Group 1 (active comparator), Group 2 (active comparator) and Group 3 (active comparator).

Goserelin + dutasteride.

Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks.

Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks.

The registry classes the interventions as drug.

More on the Plan

These levels of androgen may continue to stimulate the receptor and allow both survival of tumor cells and induction of resistance by overexpression of the receptor.

The presumption that standard androgen deprivation achieves the optimal level of androgen suppression for patients is based on the levels of androgen achieved with castration, which achieves relatively short term control of cancer in the majority of patients.

The researchers propose to test this hypothesis in a prospective, randomized trial, administering neoadjuvant androgen deprivation therapy of different types prior to radical prostatectomy for patients with clinically localized prostate cancer for 3 months.

Preoperative and intraoperative biopsies of the prostate gland will be utilized for analysis of prostatic hormones, gene expression and apoptosis.

Who Took Part

Enrollment: 35 actual participants took part.

It was open to men only aged from 18 years up to 100 years.

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

Examples of who could join: Men 18 years or older with a histologic diagnosis of clinically localized prostate cancer prior to radical prostatectomy as defined by:. Clinical stage T1-T2b. Prostate specific Antigen (PSA) less than 20. Gleason score 7-10. Patient's tumor must be considered surgically resectable .

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: patients with locally advanced or high risk disease not meeting the criteria defined above; patients who have a total testosterone less than 280 ng/dl; patients who are receiving any other investigational therapy.

How the Study Was Run

It was run as a randomized, single-group and open-label study.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

Being open-label, the Goserelin 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 2006-07 with completion listed for 2010-06.

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

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Prostate Tissue DHT (time frame: After 12 weeks of neoadjuvant androgen deprivation).

It also tracked 1 secondary outcome, for example To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 35 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 Goserelin compound page, all human trials.