Using Multiparametric MRI to Evaluate Intraprostatic Tumor Responses and Androgen Resistance Patterns in Newly Diagnosed Prostate Cancer

What Was Tested

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

It had 1 arm (groups): 1/Arm 1- Enzalutamide and Goserelin (experimental).

Patients will have an multi-parametric magnetic resonance imaging (mpMRI) guided biopsy, then receive enzalutamide and goserelin subcutaneous (SC) treatment for 6 months followed by a second mpMRI examination.

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 39 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: Prostate-specific antigen, (PSA) level is between 10 and 20 ng/ml or. Gleason score is 7 or. Stage T2b or T2c. Gleason 8 and higher OR. PSA greater than 20 at the time of diagnosis OR.

The full record lists 32 inclusion and 20 exclusion criteria; among the exclusions: patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 1 day); patients with distant metastatic disease beyond n1(regional) lymph nodes on conventional imaging studies (computed tomography (ct), mri or bone scan); history of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or other agents used in study.

How the Study Was Run

Design: single-group and open-label.

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 2015-06-03 with completion listed for 2019-12-01.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Median Tumor Volume Burden at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) Before and After Surgery (time frame: Baseline and 6 months).

It also tracked 9 secondary outcomes, for example Median Nuclear Androgen Receptor (AR) Level in Biopsy Specimens Versus Residual Tumors, Median Prostate Lesion Volume Before and After Treatment, Number of Participants With a Complete Response, Initial Multiparametric Magnetic Resonance Imaging (mpMRI) Percentage of Relative Tumor Volume Sensitivity, Number of Participants With Positive Erythroblast Transformation-specific (ETS)-Related Gene (ERG) Protein Overexpression and Initial Multiparametric Magnetic Resonance Imaging (mpMRI) Percentage of Relative Tumor Volume Specificity.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Goserelin in 39 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.