NCT04176497

PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study

Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.

Detailed description

PSMA-PET is highly sensitive and specific for detecting prostate cancer. PSMA-PET and mpMRI can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpMRI and/or PSMA-PET receiving any inevitable intrinsic plan "hot spots" or areas of dose above the prescription.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	68Ga-HBED-CC-PSMA	Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.

Timeline

• Start date: 2020-07-16
• Primary completion: 2024-02-07
• Completion: 2024-10-25
• First posted: 2019-11-25
• Last updated: 2025-12-11
• Results posted: 2025-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study