Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide.

It had 1 arm (groups): Enzalutamide, Leuprolide, radiation (other).

The registry classes the interventions as drug and radiation.

Who Took Part

The registry lists 7 actual participants took part.

It was open to men only aged from 18 years up to 90 years.

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

Examples of who could join: Histologically proven adenocarcinoma of the prostate within 6 months of screening. Eastern Cooperative Oncology Group(ECOG) score 0-2. Adequate organ and and blood marrow function. Must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer. Patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: prior treatment with agents known to have endocrine effects on prostate cancer; treatment with corticosteroids within 4 weeks of enrollment; treatment with androgens within 6 months of enrollment.

How the Study Was Run

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

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.

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

It started in 2014-05 with completion listed for 2018-06-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation (time frame: 12 months following initiation of treatment with enzalutamide plus GnRH agonist).

It also tracked 1 secondary outcome, for example Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 7 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.