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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: Recruiting Phase 1 study of Urothelial Carcinoma Bladder and Androgen Receptor Positive, sponsored by Brown University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pathologic Complete Response (pCR): pCRis defined as no viable cancer cells in the resected bladder specimen.
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 |
What NCT05839119 shows while recruiting
NCT05839119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 94-participant average among 16 other Urothelial Carcinoma Bladder trials with a reported enrollment target (66% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05839119's enrollment target sits among peer trials
32 12th of 16 higher than 5 of 16 other Urothelial Carcinoma Bladder trials
participants (enrollment target), bucketed by value
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