Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7
Conditions
Brief summary
This pilot clinical trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in treating patients with castration resistant prostate cancer that has spread to other placed in the body. Gallium Ga 68-DOTATATE PET/CT may help doctors to identify those patients with early neuroendocrine transdifferentiation and who are at greater risk for poor outcomes.
Detailed description
PRIMARY OBJECTIVE: Establish the feasibility of using gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET as a predictive imaging biomarker for neuroendocrine transdifferentiation in prostate cancer. SECONDARY OBJECTIVE: Correlate progression of disease with degree of uptake on 68Ga-DOTATATE PET examination. OUTLINE: Patients receive gallium Ga 68-DOTATATE intravenously (IV). Within 55-70 minutes, patients undergo PET/CT. After completion of study, patients are followed up for at least 1 year.
Interventions
PROCEDURECT (Computed Tomography)
Undergo PET/CT
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT
Sponsors
Emory University
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
* Patients with metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement * Ability to lie still for PET scanning * Patients must be able to provide written informed consent
Exclusion criteria
* Patients less than 18 years of age * Patients without metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement * Inability to lie still for PET scanning * Patients unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gallium Ga 68-DOTATATE Uptake | During PET/CT scan, up to 2 hours | The number of participants with uptake in each type of lesion will be reported. Will be summarized using descriptive statistics. The inter-rater agreement will be assessed by Kappa statistics or intra-class correlation coefficient. The degree of uptake will be plotted against length of time to progress, and the association will be described by Spearman correlation coefficient with 95% confidence interval (CI). In addition, will dichotomize degree of update by median and defined it as high vs. low, and apply Wilcoxon rank sum test or Fisher exact test wherever appropriate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | Date of enrollment to date of progression (radiographic progression or clinical deterioration) or death, or last follow up if event free, assessed up to 36 months | Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gallium Ga 68-DOTATATE PET/CT Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
CT (Computed Tomography): Undergo PET/CT
Gallium Ga 68-DOTATATE: Given IV
Positron Emission Tomography: Undergo PET/CT | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Gallium Ga 68-DOTATATE PET/CT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 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 | 2 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Gallium Ga 68-DOTATATE Uptake
The number of participants with uptake in each type of lesion will be reported. Will be summarized using descriptive statistics. The inter-rater agreement will be assessed by Kappa statistics or intra-class correlation coefficient. The degree of uptake will be plotted against length of time to progress, and the association will be described by Spearman correlation coefficient with 95% confidence interval (CI). In addition, will dichotomize degree of update by median and defined it as high vs. low, and apply Wilcoxon rank sum test or Fisher exact test wherever appropriate.
Time frame: During PET/CT scan, up to 2 hours
Population: One patient was subsequently found to have an additional metastatic pulmonary squamous cell carcinoma and was excluded from this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gallium Ga 68-DOTATATE PET/CT | Gallium Ga 68-DOTATATE Uptake | Bone and visceral/nodal lesions | 11 Participants |
| Gallium Ga 68-DOTATATE PET/CT | Gallium Ga 68-DOTATATE Uptake | Only bone lesions | 4 Participants |
| Gallium Ga 68-DOTATATE PET/CT | Gallium Ga 68-DOTATATE Uptake | Only nodal disease | 1 Participants |
Secondary
Progression Free Survival
Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.
Time frame: Date of enrollment to date of progression (radiographic progression or clinical deterioration) or death, or last follow up if event free, assessed up to 36 months
Population: In total, 17 patients were recruited and received at least one \[68Ga\]Ga-DOTATATE PET-CT. One patient was subsequently found to have an additional metastatic pulmonary squamous cell carcinoma and was excluded from this analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gallium Ga 68-DOTATATE PET/CT | Progression Free Survival | Moderate Ga-DOTATATE uptake with a Gleason score of 9 | 13.3 months |
| Gallium Ga 68-DOTATATE PET/CT | Progression Free Survival | Mild Ga-DOTATATE uptake with a Gleason score range of 7-8 | 36 months |
| Gallium Ga 68-DOTATATE PET/CT | Progression Free Survival | Marked Ga-DOTATATE uptake found in 7 of 16 patients analyzed and with a Gleason score range of 7-9 | 8.1 months |