The Role of 68Ga-PSMA-11 PET in MRI Fusion Biopsy and Surgery Guidance in Prostate Cancer
Investigating the Accuracy of a Molecular Imaging Probe for Prostate Cancer
Brief description of study.
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease.
Detailed description of study
A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Prostate Cancer
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Age: 18 years - 100 years
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Gender: Male
Inclusion Criteria
Presence of low or intermediate risk prostate cancer on prostate biopsy.
Scheduled for prostate biopsy, focal treatment or surgical removal of prostate
Willing and able to lie still for approximately 50 minutes in an enclosed space for the standard of care mpMRI
Exclusion Criteria
Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed).
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
This study investigates the use of a molecular imaging probe to detect the location and size of prostate cancer lesions in patients with low and intermediate risk. The probe, combined with an advanced imaging system, aims to improve the accuracy of biopsies and staging of prostate cancer. Prostate cancer is a disease where cells in the prostate gland grow uncontrollably, and this study seeks to better understand how to identify these cancerous areas accurately.
In this study, participants will undergo imaging tests using a special probe during routine procedures like biopsies or surgeries. The accuracy of this probe will be compared to standard imaging techniques, like MRI, to see if it provides better information. A detailed analysis of the removed tissue will be done to verify the probe's accuracy. This testing requires collaboration among surgeons, radiologists, and scientists.
- Who can participate: Men with low or intermediate risk prostate cancer who are scheduled for a biopsy, focal treatment, or surgery can participate. Participants must be able to remain still for about 50 minutes during an MRI scan. Those in other studies with radiation exposure or who have certain medical conditions may not qualify.
- Study details: Participants will undergo imaging tests with a molecular probe during their scheduled biopsy or surgery. This involves lying still for imaging procedures, which help compare the probe's accuracy with standard MRI scans. A placebo is not involved in this study.
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