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Radioisotope
PMSA-PET/MRI for Prostate Cancer
Phase 2
Waitlist Available
Led By Michael Repka, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5 years post-treatment
Awards & highlights
Study Summary
This trial will use PSMA-PET and mpMRI with PET-MR technology to help plan radiotherapy targets while meeting all current planning criteria.
Who is the study for?
This trial is for English-speaking men with prostate adenocarcinoma that's considered intermediate or high-risk. They must have confirmed diagnosis, be able to perform daily activities (ECOG status 0-2), and agree to release personal health information. It's not suitable for those who don't meet these criteria.Check my eligibility
What is being tested?
The study tests if using PSMA-PET/MRI technology can help define radiotherapy targets in prostate cancer treatment without increasing toxicity, while still meeting current planning standards.See study design
What are the potential side effects?
Specific side effects are not listed, but the study will monitor the toxicity of using PSMA-PET/MRI technology in targeting radiation therapy for prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 5 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 5 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toxicity after Radiation
Secondary outcome measures
Adverse Events
Biochemical control using Prostate-Specific Antigen (PSA) levels via the Phoenix definition
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PMSA-PET/MRIExperimental Treatment1 Intervention
Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment
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Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,231 Total Patients Enrolled
12 Trials studying Prostate Cancer
2,602 Patients Enrolled for Prostate Cancer
Michael Repka, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
1 Trials studying Prostate Cancer
Trevor Royce, MD, MS, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the PMSA-PET/MRI technique received approval from the FDA?
"In this Phase 2 trial, our team at Power rated the safety of PMSA-PET/MRI as a 2 on the scale. This indicates that while there is some existing data supporting its safety profile, efficacy data is yet to be established."
Answered by AI
Are there any available vacancies for patient participation in this clinical trial?
"The clinical trial listed on clinicaltrials.gov is currently not accepting new participants. The trial was first posted on July 16, 2020, and last updated on March 19, 2024. While this particular study is not recruiting at the moment, there are a total of 1379 other trials actively enrolling patients."
Answered by AI
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