Prostate Cancer Clinical Trial
PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
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.
Full 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.
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 NCCN criteria28 (Appendix A.1), with appropriate staging (e.g. bone scan).
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
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There is 1 Location for this study
Chapel Hill North Carolina, 27599, United States
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