3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy

What Was Tested

The trial (phase 2) is built around Degarelix.

It had three arms (groups): Abiraterone acetate (experimental), Abiraterone acetate and Degarelix (experimental) and Degarelix (experimental).

Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months.

The registry classes the interventions as drug.

Who Took Part

The registry lists 124 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: Male aged 18 years and above. Patients who have had post-operative radiation therapy for presumed locally recurrent disease are eligible. Rising PSA as defined above AND. Metastatic disease limited to the presence of pelvic and/or retroperitoneal nodes \< 2 cm in short axis. Patients must have a serum testosterone of 150 ng/dL or greater.

The full record lists 27 inclusion and 21 exclusion criteria; among the exclusions: known brain metastasis or evidence of metastatic disease by ct scan, physical exam, or bone scan within 4 weeks of registration; patients with equivocal uptake on a bone scan that in the clinician's opinion do not definitively constitute metastatic disease are eligible; currently active second malignancy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Degarelix group and the comparison group should start out alike.

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

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

It started in 2012-12-18 with completion listed for 2020-09-28.

It ran at 16 sites in United States (16).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression-free Survival (PFS) (time frame: 18 months). Soft Tissue Complete Response (time frame: 1 year).

It also tracked 5 secondary outcomes, for example PSA Response Rate, Overall Quality of Life, Non-hematologic Adverse Events, Testosterone and Luteinizing Hormone (LH) Recovery Rates and Correlative Tissue Analysis.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 124 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.