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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05155046
Phase
PHASE2
Status
Recruiting
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Conditions

  • Localized Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • 18F-DCFPyL — DRUG
    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.

Study Details

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 to 2 hours 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.

Key Dates

Start date
Aug 31, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 18F-DCFPyL imaging
    18F-DCFPyL imaging with routine imaging (mpMRI)

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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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