Phase 2 Study of 18F-DCFPyL PETCT Imaging to Monitor Treatment Response in Localized Prostate Cancer Patients Receiving Stereotactic Body Radiation Therapy

What this Trial Is About

Researchers are evaluating the use of an imaging agent called 18F-DCFPyL to detect how localized prostate cancer responds to treatment. The study focuses on men aged 18 years and older with newly diagnosed, intermediate or high-risk prostate cancer who do not have distant metastatic disease and are scheduled to receive stereotactic body radiation therapy SBRT with or without androgen deprivation therapy ADT. The trial aims to improve early detection of disease persistence or recurrence using advanced imaging techniques. Participants will undergo standard prostate cancer treatment with SBRT, sometimes combined with ADT. They will receive multiple 18F-DCFPyL PETCT scans and multiparametric MRI scans before, during, and after treatment. Imaging includes an injection of 18F-DCFPyL followed by PETCT scans about 1 to 2 hours later, with scans repeated at baseline, 8 weeks after ADT initiation if applicable, 6 months after SBRT, and if recurrence occurs. The study will include up to 100 men divided into groups based on treatment plans. During the study, participants will have medical history reviews, physical exams, blood and urine tests, and quality of life questionnaires. They will provide tumor samples from prior biopsies. Follow-up visits will be scheduled one month after treatment, then every three months for a year, and every six months for an additional year to monitor imaging responses and overall health. Researchers will assess imaging results to understand treatment effects and monitor biochemical control over up to two years.

18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy