18F-DCFPyL Imaging for Localized Prostate Cancer Treatment
18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy
Recruiting
Phase 2Interventional Study
Localized Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 120
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
130 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for
This trial is looking for men 18 and older who have localized prostate cancer and plan to receive specific radiation therapy. Participants will undergo imaging scans and provide health information during the study.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with localized prostate cancer.
I plan to receive stereotactic body radiation therapy.
I am at least 18 years old.
I understand and am willing to sign consent.
I agree to use birth control during the study.
I have at least one MRI-detected localized prostate cancer.
I have a performance status of 2 or lower.
If I have HIV, I am on effective treatment with an undetectable viral load.
You may not be able to join if
I have received prior androgen deprivation therapy.
I have evidence of tumor spread beyond the prostate.
I weigh more than 350 lbs.
I have conditions that may interfere with the study.
I have contraindications to radiation therapy.
I am scheduled for pelvic nodal irradiation.
I have a serum creatinine level above the normal range.
I have received prior surgery for prostate cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
* 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 …
* 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.
EXCLUSION CRITERIA:
* Receiving prior androgen deprivation therapy, radiotherapy, or surgery for prostate cancer.
* Any condition that is likely to interfere with study procedures or results.
* Individuals in whom pelvic nodal irradiation is planned.
* Serum creatinine \> 2 times the upper limit of normal.
* 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).
* Contraindications to radiation or SBRT.
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