OncoMatch/Clinical Trials/NCT05839119
Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant
Is NCT05839119 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Degarelix and Gemcitabine/Cisplatin for urothelial carcinoma bladder.
Treatment: Degarelix · Gemcitabine/Cisplatin — This study is for patients who have bladder cancer that invades into the muscle wall of the bladder. The standard treatment for patients with muscle invasive bladder cancer is to give 4 cycles of chemotherapy with the drugs cisplatin and gemcitabine, then to do an operation to remove the bladder (cystectomy). In this study, the investigators will test participants' bladder cancer to see if their bladder cancer has a receptor for testosterone inside the bladder cancer cells. If it has the testosterone receptor participants will receive a medication called Degarelix that lowers testosterone levels in the blood. Degarelix will be given during the period that participants are receiving the standard of care chemotherapy drugs gemcitabine and cisplatin. The purpose of this study is to evaluate the effects, good and bad, of adding Degarelix to standard chemotherapy for patients with bladder cancer that have the testosterone receptor.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: AR overexpression (positivity by IHC within the nucleus of tumor cells)
Androgen receptor positivity by IHC within the nucleus of tumor cells (as determined by study Pathologist) is required to receive study treatment.
Disease stage
Required: Stage PT2, PT3, PT4
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: gemcitabine
Patients who have previously received systemic or intravesical gemcitabine or platinum-containing chemotherapy
Cannot have received: platinum-based chemotherapy (cisplatin, carboplatin, oxaliplatin)
Patients who have previously received systemic or intravesical gemcitabine or platinum-containing chemotherapy
Lab requirements
Blood counts
absolute neutrophil count ≥1,000/mcL; platelets ≥100,000/mcL
Kidney function
creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥40 mL/min/1.73 m2
Liver function
total bilirubin ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤3 1.5 × institutional ULN
Cardiac function
NYHA Functional Classification class 2B or better
adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL; platelets ≥100,000/mcL; total bilirubin ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤3 1.5 × institutional ULN; creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥40 mL/min/1.73 m2. Cardiac: NYHA Functional Classification class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lifespan Cancer Institute · Providence, Rhode Island
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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