NCT05155046RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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 hour (+/- 15 minutes) 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 9 Dec 2021
- Start date
- 31 Aug 2022
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Prostate cancer
- NCT number
- NCT05155046
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 130
- From 31 Aug 2022 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving prior androgen deprivation therapy, radiotherapy, or surgery for prostate cancer.
- Individuals in whom pelvic nodal irradiation is planned.
- Contraindications to radiation or SBRT.
Other illness
- Any condition that is likely to interfere with study procedures or results.
Lab values
- Serum creatinine \> 2 times the upper limit of normal.
Other
- 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).
Criteria the registry did not label
- INCLUSION CRITERIA:
- 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.
Age in the registry: 18 years to 120 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.