Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer or Ipilimumab and Degarelix in Men With Biochemically Recurrent Castration Sensitive Prostate Cancer After Radical Prostatectomy

What Was Tested

This registered phase 2 trial tested Degarelix.

The first will use ipilimumab and degarelix prior to and following radical prostatectomy in men with newly diagnosed, oligometastatic, castration-sensitive disease.

It had two arms (groups): Ipilimumab & Degarelix With Radical Prostatectomy (experimental) and Ipilimumab & Degarelix With Prior With Radical Prostatectomy (experimental).

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 16 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: The subject must be age 18 or older, and be willing and able to provide informed consent. The subject must have histologically confirmed adenocarcinoma of the prostate with tissue confirmation at selected study site. The subject must have a history or presence of ≤ 10 bony metastatic lesions. Note: bone mets that are not clearly identified on bone imaging, but are biopsy proven are allowed. History or presence of distant metastatic lymph node(s) (e.g., retroperitoneal or non-regional pelvic lymph nodes) are allowed.

The full record lists 18 inclusion and 48 exclusion criteria; among the exclusions: patients that meet any of the criteria listed below will not be eligible for cohort a entry:; major surgery within 4 weeks of enrollment (week 1 visit); current or prior radiation therapy to the prostate prior radiation to a metastatic site (e.g., palliative radiation) is allowed.

How the Study Was Run

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2013-12-18 with completion listed for 2026-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: undetectable PSA (time frame: at 12 and 20 months).

It also tracked 3 secondary outcomes, for example progression-free survival (PFS), overall survival (OS) and Toxicity.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Degarelix in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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