Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorHackensack Meridian Health
About this trial
To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
18F-rhPSMA-7.3
DrugUtility of 18F-rhPSMA-7.3 in the diagnosis of prostate cancer after Focal Gland Treatment (SCOUT)
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: 18F-rhPSMA-7.3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after 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.
Time frame
Approximately 1 year after SOC focal therapy.Secondary outcomes
1
To report the sensitivity and specificity in evaluating PSMA-PET scan
Sensitivity and specificity will be reported under the ROC and AUC analysis.
Time frame
Approximately 1 year after SOC focal therapy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hackensack Meridian Health
Lead sponsor
Blue Earth Diagnostics
Collaborator
Source ClinicalTrials.gov