RecruitingPhase IIMale onlyEN originalProstate cancerEarly / localized

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek 18 lat lub więcej
  • Potwierdzony histologicznie rak gruczołu krokowego (adenocarcinoma)
  • Rak prostaty o niskim lub pośrednim ryzyku wg wytycznych NCCN
  • Brak wcześniejszej radioterapii miednicy lub operacji usunięcia prostaty
  • Przeprowadzona biopsja MRI w celu zidentyfikowania zmian w gruczole krokowym
  • Dobrze funkcjonujący układ moczowo-płciowy (wynik < 20 w skali IPSS)
  • Wielkość prostaty mniejsza niż 100 cm³
  • Umieszczenie markerów (fiduciali) w gruczole krokowym

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 20, 2026
Sex
Male only

Therapies / drugs in trial

Locations (1)

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/5/2026.

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