PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: PMSA-PET/MRI Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment |
Drug: 68Ga-HBED-CC-PSMA
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Toxicity after Radiation [End of treatment to 1 year post-treatment]
Change in toxicity after radiation relative to historical controls after using PSMA-PET/MRI to define radiotherapy targets
Secondary Outcome Measures
- Adverse Events [Baseline to 5 years post-treatment]
Description of adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with unfavorable-risk prostate cancer.
- Biochemical control using Prostate-Specific Antigen (PSA) levels via the Phoenix definition [Baseline to 5 years post-treatment]
Evaluating biochemical control using PSA after radiotherapy in subjects who have received PSMA-PET/MRI to define radiotherapy target volumes.
- Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI) [Baseline to 5 years post-treatment]
Measuring patient-reported quality of life using EPIC-26 and PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy target volumes.
- Screened Subjects [Through study completion, average of 2 years]
Measuring the proportion of screen subjects who are enrolled on the study
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
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Histologically confirmed prostate adenocarcinoma
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Unfavorable intermediate or high-risk, based on the NCCN criteria28 (Appendix A.1), with appropriate staging (e.g. bone scan).
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Subject has adequate performance status as defined by ECOG performance status of 0-2.
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Subject is willing and able to comply with the protocol as determined by the Treating Investigator.
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Subject speaks English (quality of life instrument is validated in English).
Exclusion Criteria:
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Contraindications for MRI
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Other prior or concomitant malignancies with the exception of:
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Non-melanoma skin cancer
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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.
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Inflammatory bowel disease
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Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
Sponsors and Collaborators
- UNC Lineberger Comprehensive Cancer Center
Investigators
- Principal Investigator: Trevor Royce, MD, MS, MPH, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- LCCC1908