Actively Recruiting
Phase II Trial of 18F-DCFPyL Imaging to Assess Treatment Response to Stereotactic Body Radiation Therapy in Localized Prostate Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-04-15
130
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying men with localized prostate cancer to see if a special imaging agent called 18F-DCFPyL can help detect how well standard treatments work. The study focuses on men 18 years and older who are newly diagnosed and plan to receive stereotactic body radiation therapy (SBRT), with or without hormone therapy called androgen deprivation therapy (ADT). The goal is to better identify treatment response early and improve monitoring of prostate cancer. Participants will receive SBRT treatment and may also get ADT depending on their plan. They will undergo several imaging scans including MRI and PET/CT using the 18F-DCFPyL radiotracer at different times: before treatment, 8 weeks after starting ADT (if applicable), 6 months after completing SBRT, and at any recurrence. The imaging helps researchers observe how the cancer responds to treatment. The study is designed to include up to 100 participants divided into groups based on their treatment plans. During the study, participants will have medical history reviews, physical exams, and blood and urine tests. They will provide samples from prior biopsies and complete quality of life questionnaires. Follow-up visits will occur one month after treatment, then every three months for a year, and every six months for an additional year, allowing researchers to track imaging results and health outcomes over time. This long-term monitoring aims to better understand prostate cancer treatment response and patient well-being.
CONDITIONS
Brief Title
18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven localized prostate cancer planned for stereotactic body radiation therapy (SBRT) with or without neoadjuvant androgen deprivation therapy (ADT)
- At least one MRI detected, biopsy proven site of localized prostate cancer
- Age 18 years or older
- ECOG performance status 0 to 2
- If HIV positive, must be on effective therapy with undetectable viral load in prior 6 months
- If chronic hepatitis B, must have undetectable viral load on suppressive therapy if needed
- If hepatitis C, must be treated and cured or on treatment with undetectable viral load
- Ability to understand and sign informed consent
- Men must agree to use adequate contraception during study and for 2 months after last 18F-DCFPyL scan
You will not qualify if you...
- Prior androgen deprivation therapy, radiotherapy, or surgery for prostate cancer
- Any condition likely to interfere with study procedures or results
- Planned pelvic nodal irradiation
- Serum creatinine more than twice the upper limit of normal
- Weight over 350 lbs or unable to fit in imaging scanner
- Evidence of tumor spread beyond prostate or seminal vesicles
- Contraindications to radiation or stereotactic body radiation therapy (SBRT)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months or as per treatment schedule
Participants undergo stereotactic body radiation therapy (SBRT) with or without neoadjuvant androgen deprivation therapy (ADT). Imaging assessments with 18F-DCFPyL PET/CT and multiparametric MRI (mpMRI) are performed at baseline, 8 weeks after ADT initiation (if applicable), and 6 months after completion of SBRT.
Up to 3 imaging visits (in-person)
Duration - Up to 2 years
Participants are followed for up to 2 years after completion of SBRT to evaluate longitudinal quality of life and biochemical control, with additional imaging at recurrence if applicable.
Additional imaging visits if recurrence occurs
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
D
Debbie-Ann N Nathan, R.N.
D
Deborah E Citrin, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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