Prostate Cancer Clinical Trial

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

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.

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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.

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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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT04243941

Recruitment Status:

Not yet recruiting

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States

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Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT04243941

Recruitment Status:

Not yet recruiting

Sponsor:


UNC Lineberger Comprehensive Cancer Center

How clear is this clinincal trial information?

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