68Ga PSMA in Preprostatectomy Patients

Prostate Cancer Clinical Trial

Official title: 68Ga PSMA-HBED-CC in Intermediate to High-Risk Preprostatectomy Patients

Status Completed

Clinical Trial Summary

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.

To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

Clinical Trial Description

This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated.

Men who are scheduled to undergo a prostatectomy are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before the prostatectomy. Information from the prostatectomy, including any MRI, CT, or ultrasound imaging, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging.

Depending on the prostatectomy findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but the surgery/biopsy results do not.

The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists. ;

Related Conditions & MeSH terms

• Neoplasms
• Prostate Cancer
• Prostatic Neoplasm
• Prostatic Neoplasm of Uncertain Behavior
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

• NCT number: NCT03388346
• Study type: Interventional
• Source: University of Iowa
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 16, 2018
• Completion date: July 22, 2021