PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04176497|
Recruitment Status : Suspended (Recruitment temporarily paused due to COVID-19 and expected to resume.)
First Posted : November 25, 2019
Last Update Posted : May 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 68Ga-HBED-CC-PSMA||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.
Other Name: gallium Ga 68-labeled PSMA-11
- Toxicity after Radiation [ Time Frame: 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
- Adverse Events [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Through study completion, average of 2 years ]Measuring the proportion of screen subjects who are enrolled on the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176497
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Trevor Royce, MD, MS, MPH||University of North Carolina, Chapel Hill|