Participants will receive 6 injections of radium-223 with monthly assessments of PSA and periodic immune response. Imaging showing positive findings on NaF PET, negative CT Scan and Tc-99m Bone Scan Histologically confirmed adenocarcinoma of the prostate To determine statistically significant changes in immune cell populations compared to baseline in participants with biochemically recurrent or 18F NaF PET scan positive prostate cancer treated with radium-223 In addition, changes in PSA kinetics, changes on PET scan findings, and safety and tolerability of radium-223 in this population will also be evaluated. Preclinical data has suggested that radium-223 can impact the immune system. Radium-223 has demonstrated the ability to improve survival in men with symptomatic prostate cancer, but it remains unknown what the impact is in patients with micrometastatic or PET positive prostate cancer in their bones Radium-223 may present an alternative option for patients with BRPC that is not associated with substantial toxicity (as seen with ADT) and may have a lasting effect due to its potential effect on the immune system and/or the bone microenvironment.Įmerging PET imaging studies will likely find evidence of micrometastatic disease, often in the bones, in biochemically recurrent prostate cancer patients, although these patients will have no standard of care that can be supported by prospective data. Recent findings by the LTIB suggest that radium-223 potentiated T-cell killing of prostate cancer cells. Radiation, even at low doses can impact immune recognition and immune cell killing of cancer cells. Radium-223 has demonstrated the ability to improve survival in men with symptomatic metastatic castration resistant prostate cancer (mCRPC) with a manageable toxicity profile, particularly in patients who have not yet received docetaxel. A primary goal in these patients is to prevent morbidity from their cancer that results from disease progression and metastatic disease on conventional imaging. Condition or diseaseĭrug: Radium-223 Drug: 18F Sodium FluorideĪndrogen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy with either definitive radiation or surgery (biochemically recurrent prostate cancer). They will also complete Quality of Life Surveys and give stool samples.Īfter treatment, participants will have long-term follow-up every 6 weeks for the rest of their lives. Participants will repeat the screening tests during the study. Radium-223 will be given on Day 1 of each cycle (1 cycle = 4 weeks) for up to 6 cycles. For this, a small plastic tube is put into an arm vein. They will have a positron emission tomography scan with intravenous (IV) injection of 18F-NaF. They will have a bone scan with injection of Tc99. They will have a scan of their chest and abdomen using radiation or magnetic resonance imaging. They will have an electrocardiogram to measure heart function. They will give tissue samples or a report from their doctor about their cancer. Their ability to do normal tasks will be reviewed. Participants will be screened with a medical history and physical exam. Patients are required to have PET or molecular imaging findings in bones, but not organs (lymph nodes are allowed). Men ages 18 and older with prostate cancer who have had surgery and/or radiation, but their PSA is rising even though no disease is visible on routine imaging scans (CT or bone scans). The primary focus is impact on the immune system with secondary focus on impact on PSA and imaging. To learn how Radium-223 affects men with rising PSA but no evidence of cancer on conventional CT or bone scan, but positive findings on PET or molecular imaging in the bones. Researchers want to see if it can treat prostate cancer and induced immune changes earlier in the disease when the cancer is only detectable by prostate specific antigen (PSA) in the blood. It uses radiation to kill cancer cells and improves survival in advanced prostate cancer. This is called biochemically recurrent prostate cancer. Some men who have been treated for localized prostate cancer with surgery or radiation still show signs of the disease in their blood. Why Should I Register and Submit Results?.
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