Radium-223 in Biochemically Recurrent Prostate Cancer
Status:
Recruiting
Trial end date:
2022-11-15
Target enrollment:
Participant gender:
Summary
Background:
Some men who have been treated for localized prostate cancer with surgery or radiation still
show signs of the disease in their blood. This is called biochemically recurrent prostate
cancer. Radium-223 is a small molecule. It uses radiation to kill cancer cells and improves
survival in advanced prostate cancer. 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.
Objective:
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. The primary
focus is impact on the immune system with secondary focus on impact on PSA and imaging.
Eligibility:
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).
Patients are required to have PET or molecular imaging findings in bones, but not organs
(lymph nodes are allowed).
Design:
Participants will be screened with a medical history and physical exam. Their ability to do
normal tasks will be reviewed. They will give tissue samples or a report from their doctor
about their cancer. They will have blood and urine tests. They will have an electrocardiogram
to measure heart function. They will have a scan of their chest and abdomen using radiation
or magnetic resonance imaging. They will have a bone scan with injection of Tc99. They will
have a positron emission tomography scan with intravenous (IV) injection of 18F-NaF.
Participants will get Radium-223 by IV. For this, a small plastic tube is put into an arm
vein. Radium-223 will be given on Day 1 of each cycle (1 cycle = 4 weeks) for up to 6 cycles.
Participants will repeat the screening tests during the study. They will also complete
Quality of Life Surveys and give stool samples.
After treatment, participants will have long-term follow-up every 6 weeks for the rest of
their lives.