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

UNC Lineberger Comprehensive Cancer Center

Status and phase: Withdrawn; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: 68Ga-HBED-CC-PSMA

Study type: Interventional

Funder types: Other

Identifiers

NCT04243941

LCCC1917

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
• Male subjects ≥ 18 years of age
• Histologically confirmed prostate adenocarcinoma
• Low or favorable intermediate risk, based on the NCCN criteria
• Subject has adequate performance status as defined by ECOG performance status of 0-2
• Subject is willing and able to comply with the protocol as determined by the Treating Investigator
• Subject speaks English (quality of life instrument is validated in English)

Exclusion criteria

• Contraindications for MRI
• Other prior or concomitant malignancies, with the exception of:
• non-melanoma skin cancer
• other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence
• Inflammatory bowel disease
• Previous transurethral resection of the prostate (TURP) or surgery of the prostate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PMSA-PET/MRI

Experimental group

Description:

Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment

Treatment:

Drug: 68Ga-HBED-CC-PSMA