Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer
Status: | Recruiting |
---|---|
Conditions: | Prostate Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/7/2018 |
Start Date: | July 9, 2018 |
End Date: | August 1, 2025 |
Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer
This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works
in evaluating cancer stage and helping treatment planning in patients with prostate cancer.
Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive
disease.
in evaluating cancer stage and helping treatment planning in patients with prostate cancer.
Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive
disease.
PRIMARY OBJECTIVES:
I. To estimate the diagnostic performance as quantified by the area under the ROC curve to
detect aggressive prostate cancer.
II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score
and clinical stage to predict the presence of aggressive prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI
parameter (T2W, DWI and DCE), as determined by local imaging review.
TERTIARY OBJECTIVES:
I. All clinical data including magnetic resonance (MR) images will be banked for future
exploratory research aims.
OUTLINE:
Patients undergo mpMRI within 3 months prior to schedule surgery.
After completion of study, patients are followed up until radical prostatectomy pathology is
reported and finalized.
I. To estimate the diagnostic performance as quantified by the area under the ROC curve to
detect aggressive prostate cancer.
II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score
and clinical stage to predict the presence of aggressive prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI
parameter (T2W, DWI and DCE), as determined by local imaging review.
TERTIARY OBJECTIVES:
I. All clinical data including magnetic resonance (MR) images will be banked for future
exploratory research aims.
OUTLINE:
Patients undergo mpMRI within 3 months prior to schedule surgery.
After completion of study, patients are followed up until radical prostatectomy pathology is
reported and finalized.
Inclusion Criteria:
- Recently diagnosed with prostate cancer for whom definitive surgical treatment is
indicated
Exclusion Criteria:
- Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe,
untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical
devices; renal failure; weight greater than allowable by scanner per institutional
standard practice)
- Prior surgical and/or non-surgical treatment for prostate cancer
- Prior hip replacement or other major pelvic surgery
We found this trial at
1
site
Philadelphia, Pennsylvania 19103
Principal Investigator: Clare M. Tempany-Afdhal
Phone: 617-732-8772
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