Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Prostate Cancer
  • Prostatic Cancer Metastatic
  • Prostatic Cancer Recurrent
  • Prostatic Neoplasm
  • Prostatic Neoplasms, Castration-Resistant
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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 pr...

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 have biochemical recurrence of prostate cancer are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before further treatment. Clinical information, including any MRI, CT, or ultrasound imaging and biopsy/surgery information, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. The study team will collect this information for about 1 year after the PSMA scan. Depending on 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 a surgery or biopsy result does 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.

Tracking Information

NCT #
NCT03389451
Collaborators
  • University of Iowa
  • Holden Comprehensive Cancer Center
Investigators
Study Chair: Michael M. Graham, MD, PhD University of Iowa