Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer

What Was Tested

The trial (not phased) is built around Degarelix.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).

Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.

The registry classes the interventions as drug.

Who Took Part

The registry lists 41 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: Histologic confirmation of prostatic adenocarcinoma by MSKCC inclusive of the following:. 3 or more positive biopsy cores or equivalent tumor specimen as confirmed by pathologist. At least 2 cores containing ≥3 mm of tissue with carcinoma or equivalent tumor specimen as confirmed by pathologist. A primary tumor Gleason score ≥ 7. Adequate primary biopsy tissue or equivalent tumor specimen as confirmed by pathologist available for protocol required analysis (i.e. bladder or TURP specimen).

The full record lists 11 inclusion and 8 exclusion criteria; among the exclusions: histologic variants in the primary tumor (histologic variants other than adenocarcinoma); current or prior chemotherapy; current or prior radiation therapy to the prostate.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Degarelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Being open-label, the Degarelix study did not mask who received what.

It started in 2012-02-24 with completion listed for 2024-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Median Percentage of Cells From Biopsy and Surgery That Are Positive For Ki-67 and Record Participant Biomarker Results and Correlates of Response.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Degarelix in 41 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.