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NCT06111781 · ClinicalTrials.gov registry record · Phase 2
The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT06111781 is a Phase 2 study of Prostate Cancer that is actively recruiting participants, run by Yale University. The registered enrollment target is 60 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06111781, a Phase 2 study of Prostate Cancer, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this clinical trial is to measure the toxicity and effectiveness of the following treatments for cFIR/cgUIR prostate cancer patients. Stereotactic body radiotherapy (SBRT) alone or Stereotactic body radiotherapy (SBRT) combined with Ultrashort GNRH Antagonist called Relugolix (an oral drug). Treatments will be randomly assigned to study patients. The main questions it aims to answer are the following: 1. Whether the proportion of men who undergo SUGAR have a superior rate of attaining PSA nadir of \<= 0.2 compared to SBRT alone, and 2. Whether SUGAR is superior to historical rates of minimal clinically important decline (MCID) in sexual and hormonal function at 6 months for patients undergoing 6 months of androgen deprivation therapy (ADT) Men aged 18+ with cFIR/cgUIR will be enrolled. Specifically, patients must meet one of the following 2 criteria: 1) Gleason score must be Gleason 3+4 with a PSA \< 20 ng/mL, or 2) Gleason 6 (3+3) and PSA \> 10 ng/mL and \< 20 ng mL.
Conditions Studied
Interventions
- DRUG Relugolix 120 MG [Orgovyx]
- RADIATION SBRT standard of care radiotherapy treatment
Study Locations (3)
Connecticut
- Yale Cancer Center - New Haven
New York
- Memorial Sloan Kettering Cancer Center - New York
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-04-15 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06111781
The ClinicalTrials.gov registry entry for NCT06111781 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Relugolix 120 MG [Orgovyx] is the first listed.
NCT06111781 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Connecticut, New York, Washington.
Frequently Asked Questions
What is clinical trial NCT06111781 about?
NCT06111781 is a clinical study titled "The SUGAR Study; SBRT and Relugolix) for Prostate Cancer". The goal of this clinical trial is to measure the toxicity and effectiveness of the following treatments for cFIR/cgUIR prostate cancer patients. Stereotactic body radiotherapy (SBRT) alone or Stereotactic body radiotherapy (SBRT) combined with Ultrashort GNRH Antagonist called Relugolix (an oral d...
What is the current status of trial NCT06111781?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-04-15. Estimated completion is 2028-02.
What conditions does trial NCT06111781 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT06111781?
The interventions under investigation include: Relugolix 120 MG [Orgovyx] (DRUG), SBRT standard of care radiotherapy treatment (RADIATION).
Who is sponsoring clinical trial NCT06111781?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06111781 being conducted?
This trial has 3 study locations across Connecticut, New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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.