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

NCT ID: NCT04243941

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2024-02-07

Brief 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

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
• 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

• 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

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

LCCC1917

Identifier Type: -

Identifier Source: org_study_id