Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant

What Was Tested

This registered phase 1 trial tested Degarelix.

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

The registry classes the interventions as combination product and drug.

More on the Plan

For patients with muscle-invasive disease (stage II and IIIA), standard of care therapy is neoadjuvant chemotherapy followed by radical cystectomy.

UCC is more common in men than women, with incidence rates of 3:1 to 4:1.

Two prospective human clinical trials related to this concept have been performed.

This study was closed due to poor accrual after accruing only one patient.

Who Took Part

2 actual participants took part.

It was open to people of any sex 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: Patients must have the following:. Histologically confirmed muscle invasive urothelial cell carcinoma of the bladder (pT2 - pT4). Eligible for standard cisplatin/gemcitabine chemotherapy as determined by the treating Medical Oncologist. Age ≥18 years. Patients must have adequate organ and marrow function as defined below:.

The full record lists 23 inclusion and 4 exclusion criteria; among the exclusions: patients who have previously received systemic or intravesical gemcitabine or platinum-containing chemotherapy; patients with uncontrolled intercurrent illness, as determined by the treating physician.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Degarelix was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2023-10-02 with completion listed for 2025-07-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathologic complete response rate (pCR) (time frame: Cystectomy following 4 (21-Day) cycles with Gemcitabine/Cisplatin).

It also tracked 4 secondary outcomes, for example Rate of non-muscle invasive disease post neoadjuvant chemotherapy (ypT0, ypTis, ypTa, ypT1), Relapse free survival at 2 years, Relapse free survival at 5 years and AR positivity in patients with a non-pCR at cystectomy.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Degarelix in 2 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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