Assess Gamma H2AX Positivity in Circulating Prostate Cancer Cells Before and After Radium 223
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|ClinicalTrials.gov Identifier: NCT02981797|
Recruitment Status : Active, not recruiting
First Posted : December 5, 2016
Last Update Posted : April 2, 2019
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer Prostate Adenocarcinoma||Other: Blood Collection During Standard of Care Treatment|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Assess Gamma H2AX Positivity in Circulating Prostate Cancer Cells Before and After Radium 223 Treatment|
|Actual Study Start Date :||March 5, 2015|
|Actual Primary Completion Date :||August 29, 2017|
|Estimated Study Completion Date :||December 2019|
Radium 223 Standard of Care
Standard of Care and Blood Collection for Baseline Circulating Tumor Cells (CTCs) Numeration and H2AX Assay. Participants who have chosen Radium 223 treatment for their prostate cancer that has spread to the bone and causing pain. Week 1 starts with the first Radium 223 treatment and week 24 ends 4 weeks after the last or sixth Radium 223 treatment. The circulating prostate cancer cell analysis will be performed within 24 hours of blood draw. Any unused blood samples for circulating prostate cancer cell analysis will be disposed per lab protocol.
Other: Blood Collection During Standard of Care Treatment
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.
- Changes in Gamma H2AX Positivity [ Time Frame: 24 weeks per participant ]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.
- Changes in Circulating Prostate Cancer Cell Numbers [ Time Frame: 24 weeks per participant ]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.
- Pain Response [ Time Frame: Up to 24 weeks ]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).
- Changes in Narcotic Analgesic Use [ Time Frame: Up to 24 weeks ]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.
- PSA Response [ Time Frame: At week 12 ]PSA response (30% decline of pretreatment PSA) at week 12.
- Bone Scan Response [ Time Frame: Up to 24 weeks ]Bone scan response based on bone scan index at week 12 and week 24 from dose 1 radium 223 treatment compared with baseline. Response based on the prostate cancer work group 2 (PCWG2) criteria will be assessed at week 12 and week 24 from dose 1 radium 223 treatment and compared with the baseline bone scan.
- Changes in Alkaline Phosphatase [ Time Frame: Up to 24 weeks ]Changes in alkaline phosphatase at week 12, week 24 compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981797
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jingsong Zhang, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|