Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment
Recruiting · NCT07011342 · Interventional (participants receive a specific treatment) · Lead sponsor: Hackensack Meridian Health
View the official record on ClinicalTrials.gov →Interventions studied
18F-rhPSMA-7.3
What this trial is about
To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack, New Jersey, United States