Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL

Trial Title: Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL

NCT ID: NCT05588128

Condition: Prostate Cancer
Biochemically Recurrent

Conditions: Official terms:
Prostatic Neoplasms
Recurrence

Conditions: Keywords:
Cancer Of Prostate
Natural History
Imaging

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: 18F-DCFpyL
Description: Administered to Cohort.
Arm group label: Cohort 1

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.

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: - History of primary treatment for prostate cancer (either surgery or radiation). - PSA >= 0.50, and testosterone >100. - Age >=18 years. - No evidence of metastatic soft tissue disease on CT scan (or MRI), or bone lesions on bone scan. - No androgen deprivation therapy (ADT), no systemic therapy within the 6 months before the study intervention, and no prostatectomy within 1 year before the study intervention. Design: - Eligible participants will have clinical evaluations and imaging studies. Participants with negative findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every year (+/-12 weeks) for follow-up imaging studies (including 18F-DCFPyL PET scans). Participants with positive findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every 6 months (+/-8 weeks) for repeat scans, not to exceed 2 scans per year. - After the initial evaluation, participants will be invited to NIH approximately every 3 months (+/- 4 weeks) for PSA testing.

Criteria for eligibility:

Study pop:
Primary clinical

Sampling method: Non-Probability Sample
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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: National Institutes of Health Clinical Center

Address:
City: Bethesda
Zip: 20892
Country: United States

Status: Recruiting

Contact:
Last name: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Phone: 888-624-1937

Start date: March 21, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: National Institutes of Health Clinical Center (CC)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05588128
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000628-C.html