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

Last updated: May 21, 2026
Sponsor: National Cancer Institute (NCI)
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

Stereotactic Body Radiation Therapy

18F-DCFPyL

Clinical Study ID

NCT05616650
10000611
000611-C
  • Ages 18-120
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:

  • Participants must have histologically confirmed, low or intermediate risk prostaticadenocarcinoma verified by biopsy (NIH Laboratory of Pathology confirmation isrequired).

  • Unifocal prostate cancer defined as a single focus of prostate cancer on MRI andPSMA 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 (barriermethod of birth control; abstinence) for the duration of study participation and upto 120 days after the last radiation treatment.

  • Ability of individual to understand and the willingness to sign a written informedconsent document.

Exclusion

EXCLUSION CRITERIA:

  • 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 adenocarcinomadetermined to be outside of the radiographically visible lesion (systematic biopsieswhich map to a radiographically detected lesion are not an exclusion criterion).

  • Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) orchemotherapy is planned.

  • Participants who are receiving any other investigational agents.

  • Participants found to have pelvic or distant metastases on pre-treatment stagingstudies.

  • Participants with an AUA-SI/IPSS score > 18.

  • Participants who have previously received curative treatment for a prior or thecurrent diagnosis of prostate cancer.

  • Active urinary tract infection assessed by urinalysis.

  • Human immunodeficiency virus (HIV)-infected individuals who are not on effectiveanti-retroviral therapy. Participants on anti-retroviral therapy with undetectableviral 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 andcured.

  • Participants with chronic HBV at screening must have an undetectable HBV viral loadon suppressive therapy.

  • Participants with hepatitis C virus (HCV) infection who have not been treated andcured.

  • Participants with HCV infection who are currently on treatment, are eligible if theyhave an undetectable HCV viral load at screening.

  • Anatomic relationship between the tumor and adjacent normal tissues judged to beunfeasible 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 lowpelvis which is expected to confer a high risk of toxicity to the experimentalradiation regimen.

  • Ineligibility or unwillingness to undergo a contrast-enhanced MRI due to inadequaterenal function (eGFR < 30), severe claustrophobia, a weight above tolerance of thescanner (> 350 lbs.), a body size unable to fit into the scanner, or implanteddevices 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-DCFPyLtracer.

  • 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 limitcompliance with study requirements.

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Stereotactic Body Radiation Therapy
Phase: 2
Study Start date:
October 19, 2023
Estimated Completion Date:
December 01, 2028

Study Description

Background:

  • Prostate cancer is the most common cancer among American men.

  • The best current validated treatment options include whole gland radiotherapy and radical prostatectomy.

  • Based on recent advances in imaging, focal ablative therapies are under investigation in attempts to deliver comparable rates of tumor control with less side effects.

  • Thus far, focal therapies such as cryotherapy, high-intensity focused ultrasound, or focal laser ablation have resulted in poor local control with the exception of implanted radiation sources which have shown in-field control rates > 90%.

  • As such, the proposed trial is designed to investigate the efficacy of a novel form of focal stereotactic body radiation therapy (SBRT) for the treatment of localized, unifocal prostate cancer.

  • Prostate specific membrane antigen (PSMA) targeted PET imaging was recently FDA approved for imaging men with suspected prostate cancer metastases who are potentially curable by radiation or surgery. 18F-DCFPyL, a second generation PSMA PET agent that binds with high affinity to PSMA yet clears rapidly from the blood pool will be used in this study.

Objective:

-To determine whether localized, tumor-directed SBRT can produce biopsy-confirmed tumor response at 24 months in participants with unifocal prostatic adenocarcinoma.

Eligibility:

  • Histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy.

  • Unifocal prostate cancer defined as a single focus of prostate cancer on imaging which is correlated with a positive targeted biopsy.

  • Age >= 18.

  • No concurrent systemic Androgen Deprivation Therapy (ADT) is planned.

Design:

  • This is a single-arm phase II trial designed to measure the efficacy of a novel application of SBRT guided with advanced prostate-specific imaging techniques.

  • Participants will initially undergo a treatment planning CT, multiparametric MRI (mpMRI), 18F-DCFPyL PET/CT imaging, a biopsy, quality of life (QoL) questionnaires and laboratory evaluations. SBRT will be administered at 26Gy in two fractions on two separate days.

  • Following completion of treatment, participants will be followed for up to 2 years through clinical evaluation, laboratory evaluations (including a complete blood count (CBC), prostate specific antigen (PSA) and testosterone measurements), QoL assessments, mpMRI, 18FDCFPyL PET/CT imaging, and a biopsy.

  • The accrual ceiling is set to 42 participants with the goal of recruiting 30 evaluable participants.

Connect with a study center

  • National Institutes of Health Clinical Center

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • National Institutes of Health Clinical Center

    Bethesda 4348599, Maryland 4361885 20892
    United States

    Site Not Available

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