Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor
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
Background: The current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland. Many people now seek out focal therapy options to decrease the side effects of treatment. Until now, several forms of physical destruction with heat (thermal ablation), cold (cryotherapy), sound waves (HIFU), laser (FLA), and electrical energy (IRE). A new type of radiation (SBRT) may be an effective way to cure men of early-stage prostate cancer with fewer side effects than standard treatments. Objective: To see how people with untreated localized prostate cancer will respond to focal therapy with SBRT. Eligibility: People aged 18 years and older with untreated localized prostate cancer (prostate cancer which has not spread outside of the prostate gland). Design: * Participants will undergo screening including blood tests, an MRI, a PSMA PET/CT (18F-DCFPyL), and a biopsy. * Small, non-radioactive, gold seeds about the size of a grain of rice will be placed in and/or around the tumor to help target the radiation treatment. * Radiation (SBRT) will occur in 2 separate sessions about 1 week apart. No sedation is used, these sessions are painless. Each session will take about 1-2 hours. Participants can go home afterwards. * Follow-up will continue for 2 years with repeat scans (MRI and PSMA PET/CT) and blood (PSA) tests. * After two years, a biopsy will be done to understand the impact of this new treatment on prostate cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat i więcej
- •Potwierdzony biopsją rak prostaty w stadium wczesnym (niska lub średnia zaawansowanie)
- •Pojedynczy guz w prostatie widoczny w badaniach obrazowych
- •Zdolność do zrozumienia i podpisania zgody na udział w badaniu
- •Mężczyźni zgadzający się na antykoncepcję przez czas badania i 120 dni po leczeniu
✗ Disqualifies
- •Zaawansowany rak prostaty (wysoka zagrażającość, wysoki wynik Gleasona)
- •Przerzuty raka poza miednicę
- •Poprzednie leczenie raka prostaty
- •Aktywne infekcje układu moczowego
- •Zakażenie HIV bez skutecznego leczenia
- •Zakażenie wirusem zapalenia wątroby B bez leczenia
- •Jednoczesne planowane chemioterapia lub hormonoterapia
- •Poważne problemy z mikcją (wysoki wynik objawów)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 120 Years
- Last updated (source)
- July 16, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
National Institutes of Health Clinical Center
Bethesda, United States
Trial contact
Debbie-Ann N Nathan, R.N.
Deborah E Citrin, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.
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