NCT04243941

PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer

LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (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 determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.

Detailed description

This study aims to determine if multi-parametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging can help optimize the placement of the high dose inhomogeneity characterizing stereotactic body radiation therapy. All radiation plans have "hot spots" of radiation, and in current practice these regions are randomly located. This study will focus those hot spots on regions determined by mpMRI + PSMA-PET to have visible tumor.

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: 2022-11-29
• Primary completion: 2024-02-07
• Completion: 2024-02-07
• First posted: 2020-01-28
• Last updated: 2024-03-21

Regulatory

• FDA-regulated drug study