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ACTIVE NOT RECRUITING Phase 2

Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

NCT06463457 · View on ClinicalTrials.gov ↗

Study Summary

This research study is being done to determine the rate of testosterone recovery after completing two years of treatment with the combination of relugolix and darolutamide as well as to assess the safety of the drugs when administered in combination. The names of the drugs in this study are: * Relugolix (a type of gonadotropin-releasing hormone receptor antagonist) * Darolutamide (a type of androgen receptor antagonist)

Interventions

  • DRUG Darolutamide
  • DRUG Relugolix

Study Locations (3)

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston
  • Brigham and Women's Hospital — Boston
  • Dana-Farber Cancer Institute — Boston

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2024-12-13
Est. Completion 2028-11-30
Phase Phase 2

Sponsor

Atish Choudhury, MD

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06463457

The ClinicalTrials.gov registry entry for NCT06463457 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atish Choudhury, MD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions — of which Darolutamide 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: NCT06463457 reports 3 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. 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 NCT06463457 about?

NCT06463457 is a clinical study titled "Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)". This research study is being done to determine the rate of testosterone recovery after completing two years of treatment with the combination of relugolix and darolutamide as well as to assess the safety of the drugs when administered in combination. The names of the drugs in this study are: * Rel...

What is the current status of trial NCT06463457?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2024-12-13. Estimated completion is 2028-11-30.

What conditions does trial NCT06463457 study?

This clinical trial studies the following conditions: Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06463457?

The interventions under investigation include: Darolutamide (DRUG), Relugolix (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06463457?

This trial is sponsored by Atish Choudhury, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06463457 being conducted?

This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial