Actively Recruiting
Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor
Led by National Cancer Institute (NCI) · Updated on 2026-04-29
42
Participants Needed
1
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed low or intermediate risk prostate adenocarcinoma verified by biopsy
- Single focus of prostate cancer on MRI and PSMA PET/CT imaging confirmed by targeted biopsy
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky score greater than 60%)
- Male participants must agree to use effective contraception during the study and for 120 days after last radiation
- Ability to understand and provide written informed consent
You will not qualify if you...
- High-risk prostate cancer features (Gleason score 8 or higher, clinical stage greater than cT2c, or PSA 20 ng/mL or higher)
- Biopsy showing grade group 2 or higher adenocarcinoma outside the visible tumor lesion
- Planned or current systemic androgen deprivation therapy or chemotherapy
- Receiving any other investigational agents
- Pelvic or distant metastases found on staging studies
- AUA-SI/IPSS urinary symptom score greater than 18
- Previous curative treatment for prostate cancer
- Active urinary tract infection
- Untreated or uncontrolled HIV, hepatitis B, or hepatitis C infections
- Tumor location unsuitable for planned treatment
- Connective tissue diseases or radiation hypersensitivity syndromes
- Active inflammatory bowel disease within the radiation field
- Prior medical or surgical history in the pelvis increasing risk of radiation toxicity
- Inability or unwillingness to undergo contrast-enhanced MRI or 18F-DCFPyL PET/CT
- Allergy to 18F-DCFPyL tracer or contraindication to fiducial marker implantation
- History of prior overlapping radiotherapy
- Uncontrolled illness or social situations limiting study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
D
Debbie-Ann N Nathan, R.N.
CONTACT
D
Deborah E Citrin, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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