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MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer

NCT07644598 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-08-04

No results posted yet for this 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.

Conditions

Interventions

RADIATION

Microboost SBRT

Microboost SBRT at a dose of 45 Gy for 5 fractions

RADIATION

Whole gland de-escalation 30 Gy

Whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions.

RADIATION

Whole gland de-escalation 35 Gy

Whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-01-31
Completion
2035-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07644598 on ClinicalTrials.gov