Recruiting
Phase 2

SBRT

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05616650

Conditions

Prostatic Neoplasms

Prostate Cancer

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

18F-DCFPyL

Stereotactic Body Radiation Therapy

Study Details

Brief 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.

Conditions

Prostatic Neoplasms

Prostate Cancer

Prostate Adenocarcinoma

Study ID

NCT05616650

Start date

Oct 19, 2023

Status verified date

Aug 28, 2026

Completion date

Dec 1, 2031

Anticipated

Primary completion date

Dec 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

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 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.

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1/Focal SBRT

Focal SBRT to the tumor focus within the prostate, with response assessed by biopsy and imaging, including 18F-DCFPyL PET/CT.

Interventions

18F-DCFPyL

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

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.

Primary outcome measure

  • Pathologic complete response rate [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Debbie-Ann N Nathan, R.N.

(240) 858-3103dnathan@mail.nih.gov

Deborah E Citrin, M.D.

(240) 760-6206citrind@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

Debbie Nathan

(301) 451-8968dnathan@mail.nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 3, 2026

Last verified

Aug 28, 2026

Keywords

  • Sbrt
  • PSMA
  • Targeted Pet Imaging
  • Prostate Adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-03.