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NCT06130995 · ClinicalTrials.gov registry record · Phase 1

Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

A Phase 1 study of Androgen Deprivation Therapy and Locally Advanced Prostate Cancer, sponsored by University of Oklahoma.

Recruiting
Registry status
Phase 1
Development phase
46
Enrollment target
1
Study location

NCT06130995: Recruiting Phase 1 study of Androgen Deprivation Therapy and Locally Advanced Prostate Cancer, sponsored by University of Oklahoma.

NCT06130995 is a Phase 1 study of Androgen Deprivation Therapy and Locally Advanced Prostate Cancer that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 46 participants, roughly in line with the 43-participant average among 5 other Androgen Deprivation Therapy trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06130995, a Phase 1 study of Androgen Deprivation Therapy and Locally Advanced Prostate Cancer, is actively recruiting participants, sponsored by University of Oklahoma.

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

Study Summary

The goal of this clinical trial is to test how effective and safe it is to use a combination of two medications, relugolix and enzalutamide, in patients with advanced prostate cancer. We want to see if this combination can help improve the chances of curing the cancer and make the patients live longer without the cancer getting worse. The main questions we want to answer in this study are: * Can using relugolix and enzalutamide together help increase the chances of curing high-risk advanced prostate cancer? * Does this combination treatment help patients live longer without their cancer getting worse? Participants in this study will be asked to take relugolix and enzalutamide as part of their cancer treatment. They will also undergo Radiation Therapy or prostatectomy, which are standard treatments for this type of cancer.

Primary Outcome

Proportion of patients will undergo evaluation for dose-limiting toxicity (DLT) to establish a tolerable dosage regimen for the combined use of relugolix and enzalutamide in individuals diagnosed with high-risk locally advanced prostate cancer. The assessment hinges on identifying DLTs associated with this treatment using 3-12 patients from the safety lead-in cohort and continuously monitoring treatment-related adverse events throughout the DLT observation period, which spans 24 months, encompas

Conditions Studied

Androgen Deprivation Therapy Locally Advanced Prostate Cancer

Interventions

  • DRUG Relugolix and Enzalutamide

Study Locations (1)

Oklahoma

  • Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC) - Oklahoma City

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2024-12-26
Est. Completion 2030-01
Phase Phase 1
University of Oklahoma

358 total trials

What NCT06130995 shows while recruiting

NCT06130995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, roughly in line with the 43-participant average among 5 other Androgen Deprivation Therapy trials with a reported enrollment target.

The record links to 2 conditions, with Androgen Deprivation Therapy appearing as the primary indexed condition, and to 1 intervention - of which Relugolix and Enzalutamide is the first listed.

NCT06130995 reports a single indexed study location in Oklahoma.

Frequently Asked Questions

What is clinical trial NCT06130995 about?

NCT06130995 is a clinical study titled "Relugolix + Enzalutamide Study in High-Risk Prostate Cancer". The goal of this clinical trial is to test how effective and safe it is to use a combination of two medications, relugolix and enzalutamide, in patients with advanced prostate cancer. We want to see if this combination can help improve the chances of curing the cancer and make the patients live long...

What is the current status of trial NCT06130995?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2024-12-26. Estimated completion is 2030-01.

What conditions does trial NCT06130995 study?

This clinical trial studies the following conditions: Androgen Deprivation Therapy, Locally Advanced Prostate Cancer.

What interventions are being tested in trial NCT06130995?

The interventions under investigation include: Relugolix and Enzalutamide (DRUG).

Who is sponsoring clinical trial NCT06130995?

This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06130995 being conducted?

This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06130995

Source: ClinicalTrials.gov NCT06130995, the US trial registry maintained by the National Library of Medicine. NCT06130995 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.