The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-12-15
• Target enrollment: 0
• Participant gender: Male

Summary

To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana Mathews
• Treatments: Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

• Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician

• Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4

• In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.

• Patients must be scheduled for biopsy or radical prostatectomy

• Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study

• Patients must be medically stable as judged by the patient's physician

• Patients must be able to lie still for a total of 60 minutes for the PET/CT scans

• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study

• Patients who have had a prior biopsy for prostate cancer cannot participate in the study

• Patients who have been treated for cancers other than skin cancers

• Subjects may not be receiving any other investigational agents for the treatment of the cancer under study

• Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds)

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI

• Prior TURP/BPH procedures, including steam/laser therapies