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NCT07644598 · ClinicalTrials.gov registry record · Phase 2
MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer
A Phase 2 study, sponsored by Georgetown University.
- Not yet
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT07644598: Clinical Trial Phase 2 study, sponsored by Georgetown University.
NCT07644598 is a Phase 2 study that has not yet begun recruiting, run by Georgetown University. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07644598, a Phase 2 study, has not yet begun recruiting, sponsored by Georgetown University.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate risk prostate cancer. The main question it aims to answer is: Is microboost SBRT with whole gland de-escalation both safe and effective in managing patients with low to intermediate-risk prostate cancer while maintaining acceptable toxicity levels? All patients will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions. Patients (Arm 1) with highest grade disease in the microboost target lesion in the absence of GG2-3 beyond the microboost target (only GG1 disease can be present outside of the microboost region) will receive whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions. Patients (Arm 2) with highest grade disease outside of the target lesion will receive whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions. Participants will be treated every other day over a two week period and then follow up after radiation treament for up to 5 years. Participants will be asked to complete questionnaires and provide blood and urine samples for research purposes.
Primary Outcome
Safety of the microboost technique will be determined based on the incidence of acute grade 2 or higher genitourinary adverse events (AEs). AEs will be assessed and graded according to the current version of the Common Terminology Criteria for Adverse Events (CTCAE) or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due
Interventions
- RADIATION Microboost SBRT
- RADIATION Whole gland de-escalation 30 Gy
- RADIATION Whole gland de-escalation 35 Gy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2026-09 |
| Est. Completion | 2035-01 |
| Phase | Phase 2 |
What is known before NCT07644598 opens enrollment
NCT07644598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Microboost SBRT is the first listed.
NCT07644598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07644598 about?
NCT07644598 is a clinical study titled "MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer". The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate risk prostate cancer. The main question it aims to answer is: Is microboost SBRT with whole gland de-escalation both safe and effective i...
What is the current status of trial NCT07644598?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2026-09. Estimated completion is 2035-01.
What interventions are being tested in trial NCT07644598?
The interventions under investigation include: Microboost SBRT (RADIATION), Whole gland de-escalation 30 Gy (RADIATION), Whole gland de-escalation 35 Gy (RADIATION).
Who is sponsoring clinical trial NCT07644598?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07644598's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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