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NCT06397703 · ClinicalTrials.gov registry record · Phase 2
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 392
- Enrollment target
- 1
- Study location
NCT06397703 is a Phase 2 study of Prostate Cancer that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 392 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06397703, a Phase 2 study of Prostate Cancer, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 392 participants
- Enrollment target
- 1
- Study location
Study Summary
For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. All patients will be followed every 6 months for up to 5 years from the first patient treated and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.
Conditions Studied
Interventions
- DRUG Leuprolide, Degarelix or Relugolix
- RADIATION Stereotactic body radiation therapy/radiosurgery (SBRT)
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2024-04-16 |
| Est. Completion | 2031-04-16 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06397703
The ClinicalTrials.gov registry entry for NCT06397703 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 392 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 (36% lower). The listed sponsor is NYU Langone Health, which has 1,164 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 Leuprolide, Degarelix or Relugolix is the first listed.
NCT06397703 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06397703 about?
NCT06397703 is a clinical study titled "ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer". For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus...
What is the current status of trial NCT06397703?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 392 participants. The study started on 2024-04-16. Estimated completion is 2031-04-16.
What conditions does trial NCT06397703 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT06397703?
The interventions under investigation include: Leuprolide, Degarelix or Relugolix (DRUG), Stereotactic body radiation therapy/radiosurgery (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT06397703?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06397703 being conducted?
This trial has 1 study location across New York. 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.