Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 120 Years
• SexMale
• Healthy volunteersNo

You may be able to join if

• INCLUSION CRITERIA:
• Participants must have histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy (NIH Laboratory of Pathology confirmation is required).
• Unifocal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET/CT imaging which is correlated with a positive targeted biopsy.
• Age >=18 years.
• ECOG performance status <=2 (Karnofsky >60%).
• Men must agree to use highly effective contraception with their partner (barrier method of birth control; abstinence) for the duration of study participation and up to 120 days after the last radiation treatment.
• Ability of individual to understand and the willingness to sign a written informed consent document.

You cannot join if

• Participants with NCCN high-risk prostate cancer features (Gleason score >=8, >cT2c, or PSA >= 20 ng/mL).
• Participants with prostate biopsies which show >= grade group 2 adenocarcinoma determined to be outside of the radiographically visible lesion (systematic biopsies which map to a radiographically detected lesion are not an exclusion criterion).
• Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.
• Participants who are receiving any other investigational agents.
• Participants found to have pelvic or distant metastases on pre-treatment staging studies.
• Participants with an AUA-SI/IPSS score > 18.
• Participants who have previously received curative treatment for a prior or the current diagnosis of prostate cancer.
• Active urinary tract infection assessed by urinalysis.
• Human immunodeficiency virus (HIV)-infected individuals who are not on effective anti-retroviral therapy. Participants on anti-retroviral therapy with undetectable viral load within the 6 months prior to registration are eligible for this trial.
• Participants with hepatitis B virus (HBV) infection who have not been treated and cured.
• Participants with chronic HBV at screening must have an undetectable HBV viral load on suppressive therapy.
• Participants with hepatitis C virus (HCV) infection who have not been treated and cured.
• Participants with HCV infection who are currently on treatment, are eligible if they have an undetectable HCV viral load at screening.
• Anatomic relationship between the tumor and adjacent normal tissues judged to be unfeasible for the planned treatment by the PI.
• Participants with connective tissue diseases.
• Participants with radiation hypersensitivity syndromes.
• Ongoing active inflammatory bowel disease within the radiation field.
• Participants with prior medical comorbidity or surgical history involving the low pelvis which is expected to confer a high risk of toxicity to the experimental radiation regimen.
• Ineligibility or unwillingness to undergo a contrast-enhanced MRI due to inadequate renal function (eGFR < 30), severe claustrophobia, a weight above tolerance of the scanner (> 350 lbs.), a body size unable to fit into the scanner, or implanted devices incompatible with an MRI (implanted cardiac devices, surgical hardware, retained shrapnel, cerebral aneurysm clips, or other incompatible objects.
• Unwillingness to undergo an 18F-DCFPyL PET/CT or known allergy to the 18F-DCFPyL tracer.
• Contraindication or inability to undergo fiducial marker implantation.
• History of prior radiotherapy overlapping with the intended radiation field.
• Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• 18F-DCFPyL (Drug): Each participant will receive a single IV dose of 18F-DCFPyL by bolus injection. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi; dose variations will be in accordance with the Nuclear Regulatory Commission (NRC) standard dose variation (i.e., 20%) permitted for diagnostic clinical studies.
• Stereotactic Body Radiation Therapy (Radiation): Intensity modulated radiotherapy will be delivered to a dose of 26Gy in two fractions with the second fraction performed within 8 days of the first session.

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan
• CT scans: Part of the study plan
• MRI: Part of the study plan
• PET scans: Part of the study plan
• questionnaires: Part of the study plan
• surgery: Part of the study plan
• radiation: Part of the study plan

Main goals

• Pathologic complete response rate (2 years)

Other goals

• Longitudinal quality of life (QoL)
• PSA kinetics
• Nadir PSA
• Absolute and relative fraction of free PSA to bound PSA
• Toxicity profile
• Rate of biochemical failure

Planned enrollment: 42 (estimated).

• National Institutes of Health Clinical Center, Bethesda, Maryland

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05616650

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 15, 2026. Public record; not medical advice.