TerminatedPhase 1

Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant

Stopped: Principal Investigator left institution

United States2 participantsStarted 2023-10-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓.1.1 Patients must have the following:
✓.1.2 Patients must have muscle-invasive urothelial cell carcinoma of the bladder (pT2 - pT4, N0-N1, M0,) as determined by bladder biopsy or trans-urethral resection of bladder tumor (TURBT) and staging imaging studies. Patients with \<10% non-urothelial histology will remain eligible for enrollment.
✓.1.3 Androgen receptor positivity by IHC within the nucleus of tumor cells (as determined by study Pathologist) is required to receive study treatment.
✓.1.4 Patients previously treated with intravesical therapy for non-muscle invasive urothelial carcinoma of the bladder are eligible for enrollment if the agent used was not gemcitabine or a platinum-containing agent (i.e, cisplatin, carboplatin, or oxaliplatin).
✓.1.5 Age ≥18 years.
✓.1.6 ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
✓.1.7 Patients must have adequate organ and marrow function as defined below:
✓.1.8 Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

Exclusion criteria

What they're measuring

Pathologic complete response rate (pCR)

Timeframe: Cystectomy following 4 (21-Day) cycles with Gemcitabine/Cisplatin

Trial details

NCT IDNCT05839119

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

View on ClinicalTrials.gov More Urothelial Carcinoma Bladder trials