Prostate Cancer Clinical Trial
PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
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.
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.
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).
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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