A Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02346526|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2015
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Castration-resistant Prostate Cancer Castration-resistant Prostate Cancer Metastatic to Bone||Procedure: Blood Tests Procedure: CT scan and bone scan Procedure: FACBC PET/MRI in a subset of participants Drug: Radium-223 dichloride||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
This research study is designed to examine a treatment strategy that is standard but still relatively new. Ra-223 consists of a series of six infusions given once every 4 weeks. It was FDA approved in 2013 for the treatment of prostate cancer that has spread to bone and has grown despite ADT ("hormonal therapy").
Ra-223 was approved because it was shown to improve the length of the lives of the men with prostate cancer who received it. Despite that important benefit, it is not known to improve other standard markers of prostate cancer such as PSA blood tests (a blood marker that is used to track cancer activity in men who have prostate cancer) and standard imaging scans such as bone scans and computed tomography (CT) scans. If participants and their doctors do not have good markers of whether or not the cancer is responding to therapy, it is harder to make decisions about whether to continue that therapy. This is a current problem.
This study makes use of Ra-223 in the standard FDA-approved way, but adds non-standard testing in an attempt to gain insight about how the drug works and how best to track patients who are receiving the drug.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm Open Label Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||February 2021|
Experimental: Radium-223 dichloride
After the screening procedures confirm that a patient is eligible to participate in the research study.
Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.
Procedure: Blood Tests
Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.
Procedure: CT scan and bone scan
Standard CT and bone scans will be carried out prior to treatment, week 9, and week 25.
Procedure: FACBC PET/MRI in a subset of participants
Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.
Drug: Radium-223 dichloride
Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.
Other Name: Xofigo
- Change from baseline in bone scan index at 2 months [ Time Frame: Baseline to 2 Months ]Bone scan index (BSI) will be used to quantitatively assess effect of therapy
- Mean percent change in bone scan lesion area by 18 month survival status [ Time Frame: 2 months (change in bone scan lesion area), 18 Months (survival status) ]Mean change in bone scan index (BSI) at 2 months (i.e. approximately week 9) as assessed by BSI will be described by 18 month survival status. In other words, decline in BSI at 2 months on therapy will be evaluated as a predictive biomarker of survival at 18 months.
- Changes in circulating tumor cell (CTC) number [ Time Frame: Day 1, day 4, weeks 5, 9, 13, 17, 21, 25, 37, 93 ]CTCs will be assessed by FDA-approved assay (Veridex CellSearch)
- Circulating biomarkers of the tumor microenvironment [ Time Frame: Day 1, day 4, weeks 5, 9, 13, 17, 21, 25, 37, 93 ]Bone turnover markers and plasma biomarkers of inflammation and angiogenesis will be assessed serially
- Changes in circulating tumor cell (CTC) number and translational biomarkers [ Time Frame: Day 1, day 4, weeks 5, 9, 13, 17, 21, 25, 37, 93 ]CTCs will be assessed by an experimental microfluidic platform
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): NCT02346526
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Philip J Saylor, MD||Massachusetts General Hospital|