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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called 18F-DCFPyL PET/CT scans to see if it can help detect areas of prostate cancer in men whose cancer has returned after initial treatment. Prostate cancer can come back in many men, and sometimes regular imaging tests can't find the cancer when it reoccurs. The goal of this study is to learn how effective this new scan is over time in spotting the disease.

To participate in this trial, men must be at least 18 years old and have had previous treatment for prostate cancer, such as surgery or radiation. They also need to have a specific blood marker called PSA at a certain level. Participants will undergo some tests, including a physical exam and blood tests, before receiving the new scan. If eligible, they can expect to have the scan and follow-up blood tests every three months, along with additional scans based on their results. The study may last up to five years, and it’s important for participants to understand the process and provide consent before joining.

Gender

MALE

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