This is a prospective biomarker study on prostate cancer patients receiving Radium 223 as standard of care. Participants will take part in this research study because they have chosen Radium 223 treatment for their prostate cancer that has spread to the bone and causing pain. Investigators want to find out if a blood test performed before and after the Radium 223 treatment will help to understand how prostate cancer cells react to this therapy. In this pilot study, researchers want to find out if Radium 223 given as part of standard treatment for prostate cancer can decrease the number of circulating prostate cancer cells. Radium 223 kills prostate cancer cells by damaging their DNA. Other than looking at the changes in the number of circulating prostate cancer cells before and after Radium 223, researchers would also like to look at the changes in a DNA damage marker, called gamma H2AX, in the circulating prostate cancer cells before and after treatment with Radium 223. Assessing the DNA damage marker gamma H2AX is investigational. It is performed in the same tube of blood that is used for assessing the changes in the number of circulating prostate cancer cells.
In this pilot study, researchers want to find out if Radium 223 given as part of standard treatment for prostate cancer can decrease the number of circulating prostate cancer cells. Radium 223 kills prostate cancer cells by damaging their DNA. Other than looking at the changes in the number of circulating prostate cancer cells before and after Radium 223, researchers would also like to look at the changes in a DNA damage marker, called gamma H2AX, in the circulating prostate cancer cells before and after treatment with Radium 223. Assessing the DNA damage marker gamma H2AX is investigational. It is performed in the same tube of blood that is used for assessing the changes in the number of circulating prostate cancer cells.
Study Type
OBSERVATIONAL
Enrollment
10
Blood collection for baseline CTC numeration and H2AX assay. Circulating prostate cancer cell analysis requires blood draw of 7.5 ml (about 1 ½ teaspoons) of blood, to be performed at the screening, 1-2 hours before the third and sixth dose of radium 223 and 24 hours after the first, third, sixth dose of Radium 223. Standard of care Radium 223 treatment is given every 4 weeks for a total of 6 treatments and post Radium 223 follow up at week 24 is also considered standard of care. Other than these standard clinic visits and treatments, the study only requires 3 extra trips to the cancer center for blood draw at 24 hours after the first, third, sixth dose of Radium 223. Blood draws other than circulating tumor cell analysis is considered standard of care and doesn't require extra visits.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Changes in Gamma H2AX Positivity
Assess changes in gamma H2AX positivity in circulating prostate cancer cells before and after Radium 223 treatment. CTC numeration, the gamma-H2AX detection and interpretation will be performed by Veridex with the cell search platform.
Time frame: 24 weeks per participant
Changes in Circulating Prostate Cancer Cell Numbers
Assess changes in circulating prostate cancer cell numbers before and after Radium 223 treatment. CTC numeration, the gamma-H2AX detection and interpretation will be performed by Veridex with the cell search platform.
Time frame: 24 weeks per participant
Pain Response
Pain response based on Brief Pain Inventory. Pain will be assessed using the Brief Pain Inventory (BPI) Items #3 (worst pain over the last 24 hours by recall), #5 (average pain over the past 24 hours by recall) and #9 (interference with daily activities and sleep).
Time frame: Up to 24 weeks
Changes in Narcotic Analgesic Use
Changes in narcotic analgesic use in participants requiring narcotics at baseline at each radium 223 treatment and week 24. Participants will self-report analgesic use over the past 24 hours.
Time frame: Up to 24 weeks
PSA Response
PSA response (30% decline of pretreatment PSA) at week 12.
Time frame: At week 12
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