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NCT05839119 · ClinicalTrials.gov registry record · Phase 1

Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant

A Phase 1 study of Urothelial Carcinoma Bladder and Androgen Receptor Positive, sponsored by Brown University.

Recruiting
Registry status
Phase 1
Development phase
32
Enrollment target
1
Study location

NCT05839119 is a Phase 1 study of Urothelial Carcinoma Bladder and Androgen Receptor Positive that is actively recruiting participants, run by Brown University. The registered enrollment target is 32 participants, below the 94-participant average among 16 other Urothelial Carcinoma Bladder trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05839119, a Phase 1 study of Urothelial Carcinoma Bladder and Androgen Receptor Positive, is actively recruiting participants, sponsored by Brown University.

RECRUITING
Registry status
Phase 1
Development phase
32 participants
Enrollment target
1
Study location

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

Urothelial Carcinoma Bladder Androgen Receptor Positive

Interventions

  • DRUG Degarelix
  • COMBINATION_PRODUCT Gemcitabine/Cisplatin

Study Locations (1)

Rhode Island

  • Lifespan Cancer Institute - Providence

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2023-10-02
Est. Completion 2032-01-01
Phase Phase 1

Sponsor

Brown University

231 total trials

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What the Registry Record Tells You About NCT05839119

The ClinicalTrials.gov registry entry for NCT05839119 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 94-participant average among 16 other Urothelial Carcinoma Bladder trials with a reported enrollment target (66% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.

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.

NCT05839119 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.

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.

What interventions are being tested in trial NCT05839119?

The interventions under investigation include: Degarelix (DRUG), Gemcitabine/Cisplatin (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05839119?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.