A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy

What Was Tested

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

Androgen can cause the growth of tumor cells.

It had 1 arm (groups): Treatment (neoadjuvant chemotherapy) (experimental).

The registry classes the interventions as drug and other.

More on the Plan

The rate of the pathologic complete response (pCR) (i.e. no evidence of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.

To determine the negative margin rate as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.

To determine the rate of near pCR (i.e. =\< 5 mm of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.

To determine the rate of pathologic T3 disease as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin.

Who Took Part

22 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: Willing and able to provide written informed consent. Eastern Cooperative Oncology Group (ECOG) performance status =\< 2. Documented histologically confirmed adenocarcinoma of the prostate. Serum testosterone \>= 150 ng/dL. Able to swallow the study drugs whole.

The full record lists 10 inclusion and 32 exclusion criteria; among the exclusions: prior use of apalutamide, abiraterone acetate or degarelix; hormonal therapy (for example \[e.g.\] leuprolide, goserelin, triptorelin, degarelix); cytochrome p450 (cyp)-17 inhibitors (e.g. ketoconazole).

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2017-03-09 with completion listed for 2018-12-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment (time frame: At 3 months).

It also tracked 8 secondary outcomes, for example Apoptotic Index (i.e. Percentage of Tumor Cells Undergoing Apoptosis), Number of Patients With a Negative Margin After 3 Months of Treatment, Overall Survival (OS), Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment, Number of Patients With no Nodal Metastases After 3 Months of Treatment and Number of Patients With Pathologic T3 Disease After 3 Months of Treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Degarelix in 22 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 Degarelix compound page, all human trials.