RecruitingPhase 1NCT05839119

Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant

Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant (TASUC-Neo): A Pilot Study of Degarelix in Combination With Neoadjuvant Gemcitabine and Cisplatin in Muscle-Invasive Urothelial Cell Carcinoma of the Bladder

Sponsor

Brown University

Enrollment

32 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma Bladder Androgen Receptor Positive

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether adding an androgen (male hormone) blocker to standard chemotherapy before bladder removal surgery helps treat muscle-invasive bladder cancer. Androgen signaling may help bladder cancer grow, so blocking it could improve outcomes. **You may be eligible if...** - You have confirmed muscle-invasive urothelial (bladder) cancer (stage pT2 to pT4) - Your cancer has not spread to distant organs - You are eligible to receive cisplatin/gemcitabine chemotherapy before surgery - You are in good enough health for major surgery **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic disease) - You are not a candidate for cisplatin-based chemotherapy - You have serious heart, liver, or kidney disease - You are already receiving hormone therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDegarelix

initial dose is 240 mg administered as two 120 mg (3 mL) injections (SC), followed by subsequent doses at 80 mg (4 mL) administered as one injection (SC)

COMBINATION_PRODUCTGemcitabine/Cisplatin

SOC Neoadjuvant Chemotherapy: Gemcitabine/Cisplatin 21-day cycles (4 cycles total) * Gemcitabine: 1000 mg/m2 (IV) Days 1 and 8 of each cycle * Cisplatin: 70 mg/m2 (if borderline renal function: 35 mg/m2) (IV) Day 1 of each cycle (if borderline renal function, days 1 and 8 of each cycle).