A Study to Assess Imaging Tools for Patients Who Have Prostate Removal Surgery
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 17-004138
Sponsor Protocol Number: 17-004138
About this study
The purpose of this study is to establish and validate imaging, surgery, and pathology protocols for C11 Choline PET/MR and pathology correlation in radical prostatectomy planning.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Participation in IRB protocol #16-007897
- Adults, age 18 and older
- Untreated male patients with moderate- to high-risk prostate cancer, who have had a clinical pelvic mpMRI as standard clinical care for diagnosis and management of prostate cancer.
- Pathologically confirmed Gleason ≥ 7 prostate cancers that are scheduled for surgical prostatectomy.
Exclusion Criteria:
- Patients who already received primary treatment or neo-adjuvant therapy.
- Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI) for staging.
- Patients who cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement [e.g., tremor, dystonia]).
- Patients who have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI.
- Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.
- Patients have contraindication to gadolinium based MR contrast agents (e.g., renal failure, severe reaction to gadolinium based MR contrast agents). eGFR should be above 30 within 30 days the time of mpMRI.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Alvin Silva, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available