PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga-PSMA-11 PET-MRI
Intervention description: Patients will undergo injection of 68Ga-PSMA-11 at the time of pre-treatment MRI scan and followed until biopsy and/or surgical resection.
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results helps inform treatment decisions.
Masking: None (Open Label)
Masking description: Two separate Radiologists (one from Nuclear Medicine and one from MRI) will do the imaging reads in a blinded fashion.
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.

      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 criteria:

        Inclusion Criteria:

          1. ≥ 18 years of age

          2. Must provide written informed consent

          3. Presence of low or intermediate risk prostate cancer or at risk of having intermediate
             risk cancer

             a. Intermediate risk prostate cancer: i. Grade group 2 = 3 + 4, or ii. Grade group 3 =
             4 + 3 b. At Risk of intermediate risk prostate cancer: i. 4K score ≥ 20%, or ii.
             Select MDx ≥ 20%, or iii. PSA Density ≥ 0.15 iv. Grade group 1= 3+3 (iv. Note: Where
             multiple cancer lesions are present on biopsy, it is allowable to have Gleason 8 or 9
             cancer lesions if they are in addition to the intermediate risk cancer as described
             above.)

          4. Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further
             biopsy, or surgical removal, or focal therapy.

          5. Willing and able to lie still for approximately 50 minutes in an enclosed space for
             the CT.

        Exclusion Criteria:

          1. Participation in another investigational trial involving research exposure to ionizing
             radiation concurrently or within 30 days.

          2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed).

          3. 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.