Metastatic Cancer, Prostate Cancer
Conditions
Keywords
stage IV prostate cancer, recurrent prostate cancer, bone metastases
Brief summary
RATIONALE: Diagnostic procedures, such as radionuclide imaging using calcium-41 (41Ca) chloride aqueous solution, may help predict progressive disease in patients with prostate cancer and bone metastasis. PURPOSE: This clinical trial is studying how well calcium-41 (41Ca) chloride aqueous solution works in diagnosing patients with prostate cancer and bone metastasis.
Detailed description
OBJECTIVES: Primary * To measure the pharmacokinetics of a single oral dose of calcium-41 (41Ca) chloride aqueous solution (\^41Ca) over 18 months in patients with hormone-refractory prostate cancer and bone metastasis. * To correlate the \^41Ca-tracer kinetics with time to disease progression, skeletal-related events, and death. Secondary * To correlate modulations in baseline urinary \^41Ca clearance with changes in clinically relevant disease parameters, including isotope bone scan data and PSA. * To combine bone turnover assessments with \^41Ca and collagen/bone cell biomarkers with clinical imaging techniques, especially isotope bone scans, to provide improved stratification of disease stage. OUTLINE: Patients receive oral calcium-41 (41Ca) chloride aqueous solution (\^41Ca) on day 1. Some patients also receive oral calcium-46 (46Ca) chloride aqueous solution (\^46Ca). Urine and blood specimens are collected periodically for 18 months. Blood samples are assayed for bone collagen residues, bone alkaline phosphatase, and PSA. Urine specimens are assessed for \^41Ca/Ca. Isotope bone scintigraphy is use to measure radioactivity. After completion of study treatment, patients are followed up periodically for 3 years.
Interventions
DRUG41 Ca
single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
Sponsors
National Cancer Institute (NCI)
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria * Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable * Prostate cancer deemed to be hormone refractory or androgen independent within the past 12 months * Evidence of bony metastasis * Either be receiving bisphosphonate therapy or have received a bisphosphonate within the last 18 months. Participants who are on not on bisphosphonate therapy nor have received it within the last 18 months should currently be on Denosumab therapy. All other anti-cancer therapies are allowed. * Age \>18 years * ECOG performance status 0-2 (Karnofsky \>50%). * Life expectancy of 6 months or greater. * Investigators are encouraged to follow good medical practice to assure that all participants have adequate hematologic, hepatic, and renal function. * Recent or planned isotope bone scan, within 12 months prior to enrollment. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Participants will be excluded who have experienced a severe skeletal related event (SRE)within the past 3 months. For this study, an SRE consists of any of the following: palliative radiotherapy to bone, pathologic fractures, spinal cord compression, hypercalcemia of malignancy, and surgery to bone to treat or prevent a fracture. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, chronic kidney disease, hyperthyroidism, or psychiatric illness/social situations that would limit compliance with study requirements. * Corrected serum calcium \<8.0 mg/dL (2.0 mmol/L) or ≥12.0 mg/dL (3.0 mmol/L)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Whose Samples Were Measured for Pharmacokinetics | Samples will be collected over 18 months | Pre-dose specimens will be provided immediately prior to dose administration. Day 1 specimens shall be collected by the subjects 6 hours after dosing (at home); all subsequent urine specimens may be collected at any time during the day and blood specimens should be taken at the same time of day, if feasible (e.g., morning fasted). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression | Samples will be collected over 18 months | Urinary 41Ca clearance will be measured and correlated with progression by RECIST 1.0 and/or PSA progression of 100% over patient nadir. |
| Number of Patients With Correlation Between 41Ca Clearance and Disease Stage | Samples will be collected over 18 months | Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 41 Ca 41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | 41 Ca |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 73.2 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex/Gender, Customized Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Patients Whose Samples Were Measured for Pharmacokinetics
Pre-dose specimens will be provided immediately prior to dose administration. Day 1 specimens shall be collected by the subjects 6 hours after dosing (at home); all subsequent urine specimens may be collected at any time during the day and blood specimens should be taken at the same time of day, if feasible (e.g., morning fasted).
Time frame: Samples will be collected over 18 months
Population: No data was collected from the specimens.
Secondary
Number of Patients With Correlation Between 41Ca Clearance and Disease Stage
Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions.
Time frame: Samples will be collected over 18 months
Population: Due to small population size Data were not collected
Secondary
Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression
Urinary 41Ca clearance will be measured and correlated with progression by RECIST 1.0 and/or PSA progression of 100% over patient nadir.
Time frame: Samples will be collected over 18 months
Population: Due to small population size of both Urinary samples and disease progression, no correlation data was collected