Northwestern University
This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with prostate cancer that is sensitive to androgen-deprivation therapy (ADT) and has spread from where it first started (primary site) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer death among men in the United States, despite the approval of several life-prolonging treatments by the Food and Drug Administration. However, over the past 10 years, there have been significant improvements in prolonging the lives of those with metastatic hormone sensitive prostate cancer, specifically by adding treatments to standard therapy, such as ADT. More recently, trials have demonstrated a benefit of using radiotherapy (high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors) to delay the progression of cancer and prolong life for patients with metastatic disease. Imaging scans with FDG-PET may be able to identify cancer sites that remain active despite standard treatment. Giving MDRT plus standard treatment to patients with FDG-PET-identified cancer sites may work better than standard treatment alone in treating metastatic hormone sensitive prostate cancer.
PRIMARY OBJECTIVES: I. To compare the progression free survival (PFS) between standard of care (SOC) + MDRT (Arm 1A) versus (vs) SOC alone (Arm 1B). (Cohort 1 \[cytotoxic therapy cohort\]) II. To compare the proportions of patients in Arm 2A vs Arm 2B who attain complete response (CR) 6 months after randomization. (Cohort 2 \[non-cytotoxic therapy cohort\]) SECONDARY OBJECTIVES: I. To compare the radiographic progression-free survival (rPFS) between Arms 1A and 1B. (Cohort 1 \[cytotoxic therapy cohort\]) II. To determine the proportions of patients with metastatic hormone sensitive prostate…
Inclusion Criteria: * Patients must have metastatic prostate cancer on conventional imaging (CT scan, MRI, and/or bone scan). * Note; Patients who had metastatic disease on conventional imaging prior to beginning ADT, but which has now resolved, are still eligible if they meet remaining eligibility criteria * Patients must be ≥ 18 years of age at the time of informed consent. * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. * Planned treatment requirements: * Cohort 1 * Patients must have mHSPC and be planning therapy with cytotoxic th…
Undergo SOC ADT
Undergo bone scan
Undergo CT
Receive SOC cytotoxic chemotherapy
Undergo FDG-PET
Undergo MDRT