Prostate Cancer
Conditions
Keywords
PSMA-PET
Brief summary
To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
Detailed description
PSMA is a protein that is highly expressed in prostate cancer cells, making it an excellent specific target for imaging with PET scans that can provide detailed information about the location, extent and aggressiveness of prostate cancer lesions. These scans have proven invaluable for identifying and characterizing prostate cancer, aiding in treatment planning, and Monitoring treatment response. It's true and fully utility in focal therapy for prostate cancer is unknown.
Interventions
DRUG18F-rhPSMA-7.3
Utility of 18F-rhPSMA-7.3 in the diagnosis of prostate cancer after Focal Gland Treatment (SCOUT)
Sponsors
Hackensack Meridian Health
Blue Earth Diagnostics
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
* Adult males 18 years or older; * Patient must have a pre-treatment MRI; * Patient underwent SOC focal therapy with either focal or hemiablation for the treatment of intermediate risk prostate cancer in the past 9 months prior to enrollment; * Intermediate risk disease as defined by American Urology Academy (AUA)/National Comprehensive Cancer Network (NCCN) guidelines (see Appendix A) * Life Expectancy of 10 years or more; * Underwent standard template biopsy before treatment with a minimum of 2 cores into the MRI visible lesion if lesion was present; * Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol; and * Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.
Exclusion criteria
* Patients under the age of 18 will be considered pediatric patients and will not be included in this study because they are thought to represent a unique population outside the scope of this study as it is aimed at identifying factors that affect adults only. * Patients previously treated with whole gland ablation or prior partial gland ablation over 9 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after focal therapy | Approximately 1 year after SOC focal therapy. | All patients will get a biopsy to assess the effectiveness of treatment at 1 year, which is standard protocol at our institutions (all patients undergo biopsy at year 1 and 3 at our institutions). The post-treatment PSMA-PET scan will be correlated to 1-year biopsy results to study the utility of such a scan. Recurrence is defined by a positive PSMA-PET scan and positive biopsy in the area of PET scan tracer uptake at 1 year after SOC focal treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To report the sensitivity and specificity in evaluating PSMA-PET scan | Approximately 1 year after SOC focal therapy. | Sensitivity and specificity will be reported under the ROC and AUC analysis. |
Countries
United States
Contacts
CONTACTOncology Clinical Research Referral Office
PRINCIPAL_INVESTIGATORNitin Yerrman, MD
Hackensack Meridian Health
Outcome results
None listed