Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
- Procedures mentioned: CT scans, Blood draws, Physical exams, PET scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Objective: To learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer."
- "Design: Participants will be screened with blood tests."
- "They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis."
- "They will have a physical exam and blood tests."
- "They will have a PET/CT scan with 18F-DCFPyL."
- "The PET/CT scan will be done 1 to 2 hours later."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at whether PET/CT scans using an injected radioactive tracer called 18F-DCFPyL can find prostate cancer and track changes over time. It is for men age 18 or older whose prostate cancer has returned after treatment. Participants may be in the study for up to 5 years.
Background: Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer. Objective: To learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer. Eligibility: Men aged 18 and older with prostate cancer that returned after treatment. Design: Participants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis. Participants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET/CT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET/CT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes. Participants will return for blood tests every 3 months. Participants will return for additional scans with 18F-DCFPyL on this schedule: Once a year if their previous scan was negative for prostate cancer. Every 6 months if their previous scan was positive for prostate cancer. Participants may be in the study up to 5 years.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have had surgery or radiation as the first treatment for prostate cancer.
- Have a PSA blood test result of 0.50 or higher. PSA is a protein used to help track prostate cancer.
- Have a testosterone blood test result above 100. Testosterone is a male sex hormone.
- Be a man age 18 or older.
- Agree to use highly effective birth control through surgical sterilization for 7 days after each tracer injection. Having no vaginal sex is also allowed if this is your usual lifestyle.
- Be able to understand the study and willing to sign a consent form.
Who can't join
- Have signs of cancer in soft tissues on a CT scan or MRI. Lymph nodes measuring 1.5 cm or less across their shortest side are allowed.
- Have signs of cancer in bones on a Tc99 bone scan.
- Have had surgery to remove the prostate within 1 year before the study procedure.
- Have had hormone-lowering treatment, called ADT, within 6 months before the study procedure.
- Have had prostate cancer treatment that works throughout the body within 6 months before the study procedure. Other experimental drugs during that time are allowed unless they involve standard chemotherapy.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* INCLUSION CRITERIA: * History of primary treatment for prostate cancer (either surgery or radiation) * Serum PSA \>= 0.50 * Serum testosterone \>100 * Age \>=18 years * Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable * The ability of a participant to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA: -Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \[MRI\] as clinically indicated). NOTE: Lymph nodes \<= 1.5 cm in the shortest dimension are allowed. * Evidence of bone lesions on Tc99 bone scan * Prostatectomy within 1 year before the study intervention * Androgen deprivation therapy (ADT) within the 6 months before the study intervention * Systemic therapy for prostate cancer within the 6 months before the study intervention. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed.
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda