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NCT06463457 · ClinicalTrials.gov registry record · Phase 2
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
A Phase 2 study of Prostate Cancer and Hormone Sensitive Prostate Cancer, sponsored by Atish Choudhury, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 3
- Study locations
NCT06463457: Active Phase 2 study of Prostate Cancer and Hormone Sensitive Prostate Cancer, sponsored by Atish Choudhury, MD.
NCT06463457 is a Phase 2 study of Prostate Cancer and Hormone Sensitive Prostate Cancer that is active but no longer recruiting, run by Atish Choudhury, MD. The registered enrollment target is 33 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06463457, a Phase 2 study of Prostate Cancer and Hormone Sensitive Prostate Cancer, is active but no longer recruiting, sponsored by Atish Choudhury, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 3
- Study locations
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)
Primary Outcome
Rate of testosterone recovery (TR) defined as the proportion of participants achieving testosterone ≥ lower limit of normal by 18 months after completion of study treatment. Participants who withdrew from trial therapy (due to early progression, toxicity, patient/physician decision or death) before completing 2 years of treatment will be excluded from the analysis. Participants who require resumption of androgen deprivation, withdraw, are lost to follow-up, or die before 18 months of post-treatm
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2024-12-13 |
| Est. Completion | 2028-11-30 |
| Phase | Phase 2 |
What the registry record for NCT06463457 still lists
NCT06463457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower).
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.
NCT06463457 reports a single indexed study location in Massachusetts.
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, Hormone Sensitive Prostate Cancer, Advanced Prostate Cancer.
What interventions are being tested in trial NCT06463457?
The interventions under investigation include: Darolutamide (DRUG), Relugolix (DRUG).
Who is sponsoring clinical trial NCT06463457?
This trial is sponsored by Atish Choudhury, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06463457's enrollment target sits among peer trials
33 560th of 735 higher than 171 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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