Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer

What Was Tested

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

It had three arms (groups): one (experimental), one (experimental) and Lupron Depot (active comparator).

GTx-758/Experimental/ nonsteroidal selective ER alpha agonist.

GTx-758/Experimental/ nonsteroidal selective ER alpha agonist.

Luteinizing Hormone Releasing Hormone Agonist.

The registry classes the interventions as drug.

More on the Plan

Patients with advanced prostate cancer undergo androgen deprivation therapy (ADT), by either LHRH agonists, LHRH antagonists, DES and other nonselective estrogens, or by bilateral orchiectomy.

GTx-758 is a nonsteroidal selective ER agonist that suppresses LH secretion by the pituitary by feedback inhibition of the hypothalamic-pituitary-gonadal axis to induce castrate levels of testosterone.

Who Took Part

Enrollment: 159 actual participants took part.

It was open to men only aged from 45 years up to 80 years.

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

Examples of who could join: Be between age 45 and 80 years of age. ECOG is \< or = 2. Screening serum total testosterone\> or = 150ng/dL. Have prostate cancer, confirmed by pathology report. Have not been treated with androgen deprivation therapy(chemical or surgical.

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: known hypersensitivity or allergy to estrogen or estrogen like drugs; history of abnormal blood clotting,factor v leiden clotting disorder, thrombotic disease; have alt or ast above 2 times the upper normal limit.

How the Study Was Run

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

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

The Leuprolide group and the comparison group ran side by side rather than switching.

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

It started in 2011-06 with completion listed for 2012-12.

It ran at 36 sites in United States (36).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants Who Are Castrate by Day 60 (time frame: 60 days).

It also tracked 2 secondary outcomes, for example Number of Participants Who Are Castrate by Day 60 and Maintained Castrate Range From Day 60 to Day 360/End of Study and Time to Castration in Participants With Prostate Cancer.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 159 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.