The Role of 68Ga-PSMA-11 PET in MRI Fusion Biopsy and Surgery Guidance in Prostate Cancer

Department
Recruiting
18 years - 100 years
Male
1 Location

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
  • Age: 18 years - 100 years
  • 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.

Updated on 04 Aug 2024. Study ID: 1805494415 (IUSCC-0658)

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