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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: Recruiting Phase 2 study of Prostate Cancer, sponsored by NYU Langone Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as the percentage of participants who survive without any signs or symptoms of prostate cancer.
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 |
What NCT06397703 shows while recruiting
NCT06397703 is an interventional study that assigns participants to a tested intervention. The registered 392 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (36% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06397703's enrollment target sits among peer trials
392 135th of 735 higher than 600 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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