Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer

Study Overview
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Brief Summary
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Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.

Official Title
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Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer Patients With Intermediate/High Risk Primary Disease or Biochemical Recurrence After Treatment

Conditions
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Prostate Cancer Recurrent, Prostate Cancer

Intervention / Treatment
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* Drug: Ga-68 P16-093 PET/CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Cohort 1): Male ≥ 18 years of age Prostate cancer patients presenting with rising PSA after radical prostatectomy for treatment if primary disease. PSA ≥ 0.2 ng/mL Patients must give informed consent for the research study, and agree to allow investigator access to clinical results following treatment plan implementation such as description of the treatment plan and PSA values following implementation of treatment plan as part of standard care, typically determined 3-4 months after treatment. Inclusion Criteria (Cohort 2): Male ≥ 18 years of age Histologically confirmed prostate cancer with following Gleason scoring at biopsy: Gleason ≥ 4+3 OR Gleason 3+4 with >30% pattern 4 or ≥3 cores positive Scheduled for radical prostatectomy (expected to occur within 60-days of scanning) Patients must give informed consent for the research study, and agree to allow investigator access to the clinical results such as SOC imaging (mpMRI, e.g.) for surgical planning if done, or biopsy data following prostatectomy including lymph node dissection biopsy data, if available. Exclusion Criteria (Cohorts 1& 2): Inability to give informed consent. Patient is unable to tolerate remaining still on the bed of the PET camera, due to physical limitations or claustrophobia. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Clinical Investigators, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biochemical recurrent prostate cancer<br>IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by whole body PET/CT scanning (pelvis to shoulders) for   60 min ( 150 min for first 10 patients/dosimetry) starting immediately after injection. A contrast CT scan follows PET scan. | Drug: Ga-68 P16-093 PET/CT scan<br>* IV injection followed by PET/CT scanning<br>* Other names: Ga-68-P16-093;|
| Experimental: Intermediate/High Risk primary prostate cancer<br>IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by list mode PET/CT scanning using a fixed FOV including the pelvis area for   50 min. | Drug: Ga-68 P16-093 PET/CT scan<br>* IV injection followed by PET/CT scanning<br>* Other names: Ga-68-P16-093;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Ga-68-P16-093 in BCR | We will compare the number and location of metastatic lesions apparently detected by 68Ga-P16-093 with the number and location of lesions detected by standard-of-care imaging. Sensitivity of the 68Ga-P16-093 PET procedure will be estimated based on the number of subjects in whom a site of disease is identified by the imaging procedure. Scans will also be reconstructed summing passes 1-5, passes 2-5, passes 3-5, and passes 1-2 to assess how image quality varies with chosen framing. | 2 weeks | 
| The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions | Change in management will be based on physician questionnaires including confirmation of actual treatment. | 4 months | 
| Sensitivity and Specificity of Ga-68-P16-093 in primary PCa | We will estimate the sensitivity and specificity of the 68Ga-P16-093 PET imaging by comparing the PET SUV values and whole-mount pathology findings on a sextant basis (6 sextants per subject x 10 subjects). Images will be evaluated from   5 min to 60 minutes of scanning in 5-10 minutes up to 45 min frames. | 2-60 days following PET/CT scan |