A Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer
A Single-arm Open Label Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer
2 other identifiers
interventional
22
1 country
1
Brief Summary
The purpose of this study is to look for markers of how Ra-223 improves the lives of men with prostate cancer. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
Started Apr 2015
Typical duration for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedResults Posted
Study results publicly available
September 29, 2022
CompletedSeptember 29, 2022
September 1, 2022
4.5 years
January 13, 2015
June 24, 2022
September 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Scan Index
Automated bone scan index (aBSI) is an imaging prognostic biomarker used to quantitatively assess effect of therapy. aBSI expresses the tumor burden in bone as a percent of the total skeletal mass. An aBSI value of 1.0 indicates the tumor(s) to be present in 1% of the entire skeleton (arms and legs included).
Baseline to 2 Months
Secondary Outcomes (5)
Percentage of Skeletal Mass Occupied by a Lesion, Stratified by 18 Month Survival Status
Baseline and 2 months
Circulating Tumor Cell (CTC) Number
Baseline/Day 1, Day 30, Day 60
Circulating Biomarkers of the Tumor Microenvironment
Baseline/Day 1, Day 30, Day 60
Baseline Pain Score Evaluation as a Predictor of Survival
Baseline through study completion, up to approximately 5 years
Baseline Global Health Score Evaluation as a Predictor of Survival
Baseline through study completion, up to approximately 5 years.
Study Arms (1)
Radium-223 dichloride
EXPERIMENTALAfter 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. * Blood Tests * CT scan * Bone scan * FACBC PET/MRI in a subset of participants
Interventions
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.
Standard CT scans will be carried out prior to treatment, week 9, and week 25.
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.
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.
Standard bone scans will be carried out prior to treatment, week 9, and week 25.
Eligibility Criteria
You may qualify if:
- Male age ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of the prostate. Life expectancy of at least 6 months.
- ECOG performance status of zero, one, or two.
- Bone-predominant metastatic CRPC: at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node metastasis is allowed).
- Symptomatic as defined by either of the following:
- (a) Regular use of analgesic medication for cancer-related bone pain (≥ level 1; WHO ladder for cancer pain), or
- (b) Treatment with EBRT for bone pain (though EBRT must be completed ≥12 weeks prior to enrollment in this trial).
- Judged by investigator to have progressive disease sufficient to clinically justify standard-of-care radium-223 treatment.
- Subjects must be able to understand and be willing to sign the written informed consent form.
- All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF).
- No intention to use cytotoxic chemotherapy within the next 6 months. Subjects must agree to use adequate contraception beginning at the signing of the ICF until at least 6 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator.
- Acceptable hematology and serum biochemistry screening values:
- White Blood Cell Count (WBC) ≥ 3,000/mm3
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- Platelet (PLT) count ≥ 100,000/mm3
- +6 more criteria
You may not qualify if:
- Treatment with cytotoxic chemotherapy within previous 28 days, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 28 days previous (however, ongoing neuropathy is permitted).
- Received any investigational compound within 28 days prior to the first dose of study drug or planned during the treatment period or follow-up.
- Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony metastases.
- Received previous radiotherapy to approximately \>25% of bone marrow.
- Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer).
- Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) or other imaging modality.
- Presence of brain metastases.
- Lymphadenopathy exceeding 6 cm in short-axis diameter.
- Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
- Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression.
- Any other serious illness or medical condition, such as but not limited to:
- Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
- Cardiac failure New York Heart Association (NYHA) III or IV
- Crohn's disease or ulcerative colitis
- Known bone marrow dysplasia
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Bayercollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Philip Saylor, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Philip J Saylor, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 13, 2015
First Posted
January 27, 2015
Study Start
April 1, 2015
Primary Completion
October 1, 2019
Study Completion
December 1, 2020
Last Updated
September 29, 2022
Results First Posted
September 29, 2022
Record last verified: 2022-09