RecruitingPhase 2NCT05155046

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

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


Sponsor

National Cancer Institute (NCI)

Enrollment

130 participants

Start Date

Aug 31, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special type of PET scan — called 18F-DCFPyL imaging, which targets a protein on prostate cancer cells (PSMA) — to monitor how localized prostate cancer responds to stereotactic body radiation therapy (SBRT), a highly precise form of radiotherapy. The study aims to see if these scans can detect treatment response earlier and more accurately than standard methods. **You may be eligible if...** - You are 18 or older with biopsy-proven localized prostate cancer - You are planned to receive SBRT as your primary prostate cancer treatment (with or without hormone therapy) - You have at least one tumor confirmed on MRI and biopsy - Your cancer has not spread to lymph nodes or other parts of the body - If you have HIV, hepatitis B, or hepatitis C, it must be well-controlled **You may NOT be eligible if...** - You have already received androgen deprivation therapy, radiation, or surgery for prostate cancer - Your cancer has spread beyond the prostate or seminal vesicles - Pelvic lymph node radiation is part of your planned treatment - Your kidney function is significantly impaired - You weigh more than 350 lbs or cannot fit in the imaging scanner Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-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.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05155046


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