Recruiting
Phase 2

18F-DCFPyL

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05155046

Conditions

Localized Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

18F-DCFPyL

Study Details

Brief summary:

Background:

Identifying medium- and high-risk prostate cancer early may allow for treatments to work. But identification can be hard. Researchers want to see if a radiotracer used during PET scans can help.

Objective:

To test how an imaging agent called 18F-DCFPyL detects response to standard prostate cancer treatment.

Eligibility:

People ages 18 and older with newly diagnosed prostate cancer who have no evidence of distant metastatic disease and plan to get stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT).

Design:

Participants will be screened with:

Medical history

Physical exam

Blood tests

MRI

Participants will have baseline MRI and PET/CT scans. For the MRI, they may get a contrast agent by IV injection. For the PET/CT scan, they will get an IV injection of 18FDCFPyL. About 1 hour (+/- 15 minutes) later, they will get the PET/CT scan. During the scans, participants will lie on their back and remain still for 45 minutes to 1 hour. These scans will be repeated at different points during the study.

Participants will get SBRT with or without ADT.

Participants will complete questionnaires about their quality of life.

Participants will be asked about any symptoms they are having. They will also be asked about medications they are using. They may have a physical exam.

Participants will give blood and urine samples. They will give a tumor sample from a biopsy they have had in the past.

After treatment, participants will have follow-up visits. These will occur 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year.

Conditions

Localized Prostate Cancer

Study ID

NCT05155046

Start date

Aug 31, 2022

Status verified date

Aug 19, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • Biopsy proven localized prostate cancer in whom stereotactic body radiation treatment (SBRT) with or without neoadjuvant androgen deprivation therapy (ADT) is planned for definitive management (NIH laboratory of pathology confirmation is not required).
  • Must have at least 1 MRI detected, biopsy proven localized prostate cancer.
  • Age >= 18 years
  • ECOG performance status <= 2
  • For individuals with evidence of human immunodeficiency virus (HIV) infection, individuals must be on effective anti-retroviral therapy with undetectable viral load within the prior 6 months are eligible.
  • For individuals with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • For individuals with a history of hepatitis C virus (HCV), the infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Men must agree to use adequate contraception with their partner (hormonal or barrier method of birth control; abstinence) for the duration of study participation and 2 months after the last 18F-DCFPyL scan.

EXCLUSION CRITERIA:

  • Receiving prior androgen deprivation therapy, radiotherapy, or surgery for prostate cancer.
  • Any condition that is likely to interfere with study procedures or results.
  • Individuals in whom pelvic nodal irradiation is planned.
  • Serum creatinine > 2 times the upper limit of normal.
  • Weighing > 350 lbs (weight limit for scanner table), or unable to fit in imaging gantry.
  • Evidence of tumor spread beyond the prostate/seminal vesicles (lymph nodes, metastases).
  • Contraindications to radiation or SBRT.

Study Design

Enrollment

130 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 18F-DCFPyL imaging

18F-DCFPyL imaging with routine imaging (mpMRI)

Interventions

18F-DCFPyL

18F-DCFPyL imaging will be performed at baseline, 8 weeks after ADT initiation, 6 months post SBRT and at recurrence. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi.

Primary outcome measure

  • Imaging response to treatment [ Time Frame: Baseline, 8 weeks after ADT initiation (if applicable), 6 months post SBRT, at recurrence ]

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

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 1, 2026

Last verified

Aug 19, 2026

Keywords

  • Localized Prostate Cancer
  • Radiotherapy
  • Prostate Specific Membrane Antigen
  • Androgen Deprivation Therapy
  • longitudinal quality of life

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 2026-09-01.