A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Observation of 18F-DCFPyL lesions in BRPC
Study Overview
Brief Summary
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.
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Detailed Description
Background:
- Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men.
- About 25,000 to 50,000 men each year develop a rising prostate-specific antigen (PSA) after definitive radiation or surgery for early-stage disease but have negative findings on computed tomography (CT) and Tc99 bone scan (standard imaging in prostate cancer).
- The recent Food and Drug Administration (FDA) approval of 18F-DCFPyL PET imaging provides an opportunity to locate micrometastatic lesions in patients with recurrent disease.
- It is unknown how these lesions (or prostate cancer) evolve over time in men with positive findings on 18F-DCFPyL PET imaging.
Objective:
-To observe participants with biochemically recurrent prostate cancer for 5 years to understand the evolution of 18F-DCFPyL PET lesions in this population.
Eligibility:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion 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.
Arms & Interventions
Cohort 1
Participants with biochemically recurrent prostate cancer
Intervention: 18F-DCFpyL (Drug)
Outcomes
Primary Outcomes
Observation of 18F-DCFPyL lesions in BRPC
Time Frame: baseline through 5 years
Initial 18F-DCFPyL imaging, every 6 months (+/- 8 weeks) for participants positive on imaging, and every 12 months (+/- 12 weeks) for participants negative on imaging until 5 years.
Secondary Outcomes
- Progression on 18F-DCFPyL(baseline through 5 years)
- Evaluate PSA doubling in association with 18F-DCFPyL changes(baseline through 5 years)