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

NCT05155046 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-04-15

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155046 on ClinicalTrials.gov