OncoMatch/Clinical Trials/NCT05616650
Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor
Is NCT05616650 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies 18F-DCFPyL for prostatic neoplasms.
Treatment: 18F-DCFPyL — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Excluded: Stage NCCN HIGH-RISK PROSTATE CANCER FEATURES (GLEASON SCORE >=8, >CT2C, OR PSA >= 20 NG/ML)
Participants with NCCN high-risk prostate cancer features (Gleason score >=8, >cT2c, or PSA >= 20 ng/mL)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: Androgen Deprivation Therapy
Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.
Cannot have received: chemotherapy
Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.
Cannot have received: curative treatment for prostate cancer
Participants who have previously received curative treatment for a prior or the current diagnosis of prostate cancer.
Cannot have received: radiotherapy overlapping with the intended radiation field
History of prior radiotherapy overlapping with the intended radiation field.
Lab requirements
Kidney function
ineligibility or unwillingness to undergo a contrast-enhanced MRI due to inadequate renal function (eGFR < 30)
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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