Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.

What Was Tested

This registered phase 2 trial tested Degarelix.

The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix.

It had 1 arm (groups): Docetaxel + Degarelix (experimental).

The registry classes the interventions as drug.

More on the Plan

This study will look at two drugs, docetaxel and degarelix, which are both FDA approved for the treatment of prostate cancer.

Docetaxel is a standard chemotherapy treatment for metastatic prostate cancer.

Usually, docetaxel is given after ADT.

This study will look at how your cancer changes when docetaxel is started before ADT.

Who Took Part

The registry lists 52 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: Histological or cytological diagnosis of adenocarcinoma of the prostate. Any visceral metastases identified by CT scans or MRI. Site(s) of bony metastasis identified by nuclear bone scan, MRI, and/or CT scan. Lymph node based disease not considered to be within a single radiation therapy port (e.g. at or above the aortic bifurcation.). Non-castrate testosterone level, \>50 ng/dl, at study enrollment.

The full record lists 19 inclusion and 12 exclusion criteria; among the exclusions: CNS metastases (brain or leptomeningeal); osseous metastases felt in the opinion of the clinician to be high-risk for impending pathologic fracture or spinal cord compression; subjects must not have received any previous androgen deprivation therapy (lhrh agonist or lhrh antagonist) or cytotoxic therapy for prostate cancer in the metastatic setting.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Degarelix 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 2017-03-01 with completion listed for 2021-03-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: PSA Response at 10 Months (time frame: 10 months).

It also tracked 7 secondary outcomes, for example PSA Response at 6 Months, Number of Grade 3 and 4 Adverse Events Related to Docetaxel During First 4 Cycles, Frequency of Disease Progression at 12 Weeks Using PSA, PSA Response at 12 Weeks, Time to Development of Castration Resistance After Initiation With ADT and Progression Free Survival.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Degarelix in 52 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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