Prostate Cancer Clinical Trial
— PSMA PETOfficial title:
Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients
Verified date | November 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.
Status | Completed |
Enrollment | 225 |
Est. completion date | October 24, 2016 |
Est. primary completion date | October 24, 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below: - Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of the Prostate Risk Assessment) score = 5, Prostate-specific antigen (PSA) = 15 ng/mL and/or Gleason score = 4+4. - Patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months. i. These patients may have received androgen deprivation therapy prior to imaging. - Patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27). i. Patients with castrate resistant prostate cancer can be either on treatment or off treatment 2. Age > 18. 3. Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent). 4. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI. 2. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.). 3. Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.). |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Thomas Hope |
United States,
Lawhn-Heath C, Flavell RR, Behr SC, Yohannan T, Greene KL, Feng F, Carroll PR, Hope TA. Single-Center Prospective Evaluation of (68)Ga-PSMA-11 PET in Biochemical Recurrence of Prostate Cancer. AJR Am J Roentgenol. 2019 Aug;213(2):266-274. doi: 10.2214/AJR — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases | Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate will be calculated with the corresponding 95% confidence interval. | 1 day | |
Primary | Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis | Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval. | 1 day | |
Primary | Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis | Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval. | 1 day | |
Primary | Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis | Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval. | one month | |
Secondary | Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group | 68Ga-labeled prostate-specific membrane antigen 11 (Ga68-PSMA-11) PET positivity rate by prostate-specific antigen (PSA) level is calculated by the number of positive reads divided by the total number of patients in the BCR Group per PSA value quintile (Detection rate (d) = total number of positive reads (t)/ total number of participants (N)). | Up to 1 year | |
Secondary | Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management | Change in participant medical management was determined based on the results of surveys given to each participant's treating physician. Results of the survey were categorized as a major change in participant's medical management, a minor change in participant's medical management, no change to participant's medical management, or change to participant's medical management is unknown. These categories were developed based on a predetermined categorization schema. | Up to 1 year |
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