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Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant
NCT05839119 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Degarelix
- COMBINATION_PRODUCT Gemcitabine/Cisplatin
Study Locations (1)
Rhode Island
- Lifespan Cancer Institute — Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2032-01-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05839119
The ClinicalTrials.gov registry entry for NCT05839119 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 268 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Urothelial Carcinoma Bladder appearing as the primary indexed condition, and to 2 interventions — of which Degarelix is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05839119 reports 1 study location spanning 1 distinct geographic area — top geographies include Rhode Island. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05839119 about?
NCT05839119 is a clinical study titled "Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant". 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 (cy...
What is the current status of trial NCT05839119?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2023-10-02. Estimated completion is 2032-01-01.
What conditions does trial NCT05839119 study?
This clinical trial studies the following conditions: Urothelial Carcinoma Bladder, Androgen Receptor Positive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05839119?
The interventions under investigation include: Degarelix (DRUG), Gemcitabine/Cisplatin (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05839119?
This trial is sponsored by Brown University, which has 268 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05839119 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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