MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer
Public ClinicalTrials.gov record NCT07644598. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study of MRI-based Focal Intraprostatic SIB (Simultaneous Integrated Boost) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07644598
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 58 participants
Conditions and interventions
Conditions
Interventions
- Microboost SBRT Radiation
- Whole gland de-escalation 30 Gy Radiation
- Whole gland de-escalation 35 Gy Radiation
Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2034
- Last update posted
- Aug 19, 2026
2026 – 2035
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lombardi Comprehensive Cancer Center, Georgetown University | Washington D.C. | District of Columbia | 20007 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07644598, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07644598 live on ClinicalTrials.gov.