NCT03204123

PSMA PET Imaging of Recurrent Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,171 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.

Conditions

• Prostate Adenocarcinoma
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Ga-HBED-iPSMA PET	Patients will be injected with 100-300 MBq of 68Ga-HBED-iPSMA and after a waiting of 60-90 minutes patients will be scanned from mid-skull to mid-thigh.
DIAGNOSTIC_TEST	PET/CT	PET/CT will be acquired using a GE 710 or 690 time-of-flight PET/CT scanner. Following a waiting period of 60-90 minutes post 68Ga-HBED-iPSMA administration, patients will be scanned from top of the skull to mid-thigh. Images will be acquired with patients in a supine position with their arms raised above their head. If patients cannot raise their arms above the head, the arms will be comfortably positioned and secured by the side of the patient. The PET may be combined with a CT scan as a PET/CT or a MRI scan as PET/MR.
DIAGNOSTIC_TEST	MRI	Patients may undergo a diagnostic MRI of the prostate, other body parts or a whole-body MRI at the same imaging session as clinically indicated.

Timeline

• Start date: 2017-06-26
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2017-06-29
• Last updated: 2025-07-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study