68Ga-PSMA-11 PET/CT for Assessment of High Risk or Recurrent Prostate Cancer

Official Title

68Ga-PSMA-11 Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of High Risk or Recurrent Prostate Cancer

Summary:

Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate specific antigen levels. This study proposes to use Gallium-68-PSMA-11 (68Ga-PSMA-11) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the prostate cancer has recurred.

Trial Description

Primary Outcome:

  • Sensitivity of 68Ga-PSMA-11 PET/CT imaging in the assessment of high risk and recurrent prostate cancer.
Secondary Outcome:
  • Predictive value of 68Ga-PSMA-11 PET/CT imaging
  • Accuracy of 68Ga-PSMA-11 PET/CT imaging
  • Specificity of 68Ga-PSMA-11 PET/CT imaging
  • Number of participants with self-reported 68Ga-PSMA-11-related adverse event
This is a prospective registry study to evaluate the diagnostic utility of 68Ga-PSMA-11 PET/CT to stage patients with high risk prostate cancer, localize sites of biochemical recurrence of prostate cancer, and restage patients with advanced prostate cancer before and after onset of new therapy. Eligible subjects will undergo a 68Ga-PSMA-11 PET/CT at the British Columbia Cancer (BCC) - Vancouver. Each subject will receive a 68Ga-PSMA-11 PET/CT scan at the BCC-Vancouver, as part of this research study. Each study subject will receive a bolus intravenous dose of 68Ga-PSMA-11. The subject will rest in a comfortable chair for 60 minutes and will then be taken to the PET/CT scanner for images. The PET/CT scan will take approximately 2.5 hours of patient time above and beyond the time needed for standard of care. Medical History Questionnaire: Demographic and medical history data will be collected either in person before the PET scan appointment or by mail or phone, whichever is the most convenient to the subject. Follow-up assessments: All subjects will be contacted by phone the day after the injection of 68Ga-PSMA-11. The subjects will be asked if they experienced any undesirable effects during the 12 hours after the administration of 68Ga-PSMA-11. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 68Ga-PSMA-11 administration. All subjects will be followed for 5 years following the 68Ga-PSMA-11 PET/CT exam to assess the presence of recurrence. The evaluation will include a chart review of available imaging, laboratory tests, and treatment. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information.

View this trial on ClinicalTrials.gov

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Resources

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