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

NCT ID: NCT04176497

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-16
• Study Completion Date: 2024-10-25

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PMSA-PET/MRI

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

Group Type: EXPERIMENTAL

68Ga-HBED-CC-PSMA

Intervention Type: DRUG

Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.

Interventions

68Ga-HBED-CC-PSMA

Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.

Intervention Type: DRUG

Other Intervention Names

gallium Ga 68-labeled PSMA-11

Eligibility Criteria

Inclusion Criteria

• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Histologically confirmed prostate adenocarcinoma
• Unfavorable intermediate or high-risk, based on the National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol.
• 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
• Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Repka, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://unclineberger.org

UNC Lineberger Comprehensive Cancer Center

Other Identifiers

LCCC1908

Identifier Type: -

Identifier Source: org_study_id