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18F-DCFPyL Imaging for Prostate Cancer Treatment Response

This study is looking at how well an imaging agent called 18F-DCFPyL can show if treatment for localized prostate cancer is working. Researchers want to see if this special PET scan can detect how your body responds to stereotactic body radiation therapy (SBRT), which is a type of radiation treatment, with or without hormone therapy (androgen deprivation therapy or ADT). The study will track changes in imaging results over time to see if they can identify treatment success or recurrence early. You may be able to join if you are a man aged 18 or older with newly diagnosed localized prostate cancer and are planning to receive SBRT.

Study design
This is an interventional study planning to enroll 130 male participants. The study is not randomized or blinded.
What's involved
You will have 18F-DCFPyL imaging at the start of the study, 8 weeks after starting ADT (if applicable), 6 months after SBRT, and if your cancer returns. You will also have a medical history, physical exam, blood tests, and MRI scans, with a possible contrast agent injection for the MRI.
Compensation
Not stated in the trial record.
Follow-up
Your imaging response will be measured at baseline, 8 weeks after ADT initiation (if applicable), 6 months post SBRT, and at recurrence.

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NCT05155046

18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~130 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:18F-DCFPyL

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Imaging response to treatment
Measured over Baseline, 8 weeks after ADT initiation (if applicable), 6 months post SBRT, at recurrence

Conditions

Localized Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Deborah E Citrin, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Debbie-Ann N Nathan, R.N.
[email protected]
(240) 858-3103
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Imaging response to treatmentBaseline, 8 weeks after ADT initiation (if applicable), 6 months post SBRT, at recurrence

    For the purpose of this study, the imaging response to treatment will be categorized separately in the radiation treatment volume (in field; local) and distantly (outside the radiation treatment volume). In-field (in the radiation target volume) 18F-DCFPyL PET/CT treatment response in field will be evaluated using a descriptor (complete, partial, progression) based on maximum SUV and volume of uptake relative to the pre-treatment imaging. Presence of new areas of uptake suspicious for prostate cancer outside of the region of radiation treatment will be considered progression but will be scored separately and will not impact the assessment of response from radiation locally.