Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2012-11-30
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Prostate Cancer Imaging
Subjects will receive multi-sequence Magnetic Resonance Imaging (MRI) of the prostate and pelvis. This scan will take approximately 90 minutes.
In addition, a 18F-Choline PET/CT(Positron emission tomography/computed tomography) scan of the abdomen and pelvis is performed. This scan will take about 30 minutes. Subjects may receive an additional 30 minute scan, if needed.
Patients participating in an active surveillance program at the University of Michigan may receive yearly imaging followed by a prostate biopsy procedure.
Prostate Cancer Imaging
After imaging is completed, subjects will be scheduled for a prostate biopsy performed as part of their clinical care. If the imaging has identified suspicious lesions in the prostate, these regions will be made visible for the Urologist to be targeted for additional biopsies. These additional biopsies will undergo histological evaluation and further metabolomic testing to better understand metabolic differences between various grades of prostate cancer lesions.
Interventions
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Prostate Cancer Imaging
After imaging is completed, subjects will be scheduled for a prostate biopsy performed as part of their clinical care. If the imaging has identified suspicious lesions in the prostate, these regions will be made visible for the Urologist to be targeted for additional biopsies. These additional biopsies will undergo histological evaluation and further metabolomic testing to better understand metabolic differences between various grades of prostate cancer lesions.
Eligibility Criteria
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Inclusion Criteria
* Males 40 years of age or older with known (biopsy-confirmed) primary adenocarcinoma of the prostate undergoing active surveillance scheduled for prostate biopsy (population group B)
Exclusion Criteria
* Prostate biopsy within 6 weeks prior to PET or MRI imaging
* Active inflammatory bowel disease within the last 6 months
* Acute prostatitis within the last 6 months
* A non-urologic bacterial infection requiring active treatment with antibiotics
* Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
* Previous radiation treatment of the pelvis
* Symptomatic distal rectal stenosis
* Known hypersensitivity to glucagon
* Pheochromocytoma, insulinoma or galactosemia
* Insulin-dependent diabetes
40 Years
MALE
No
Sponsors
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United States Department of Defense
FED
University of Michigan
OTHER
Responsible Party
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Morand Piert, MD
Principal Investigator
Principal Investigators
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Morand R. Piert, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Hospital
Locations
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University of Michigan Health Systems
Ann Arbor, Michigan, United States
Countries
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References
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Piert M, Montgomery J, Kunju LP, Siddiqui J, Rogers V, Rajendiran T, Johnson TD, Shao X, Davenport MS. 18F-Choline PET/MRI: The Additional Value of PET for MRI-Guided Transrectal Prostate Biopsies. J Nucl Med. 2016 Jul;57(7):1065-70. doi: 10.2967/jnumed.115.170878. Epub 2016 Mar 16.
Other Identifiers
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HUM00059514
Identifier Type: -
Identifier Source: org_study_id
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