An interventional study of 3 Tesla Magnetic Resonance Imaging and Gadodiamide in Health Status Unknown and Prostate Carcinoma, sponsored by OHSU Knight Cancer Institute. Terminated at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2019-04-03.
Sponsored by OHSU Knight Cancer Institute · Not applicable, Interventional, and Diagnostic
This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.
PRIMARY OBJECTIVES:
I. To improve the treatment of patients with prostate cancer utilizing diagnostic multi-parametric magnetic resonance imaging (MRI) and MRI-guided prostate biopsy combined with molecular and clinical data to help determine the extent of prostate cancer and risk of disease progression.
II. To determine the relative accuracy of transrectal MRI-guided versus ultrasound-guided biopsy for the diagnosis of prostate cancer in patients with an appropriate dominant target lesion at multiparametric MRI, using pooled cancer diagnoses by either MRI-guided or ultrasound-guided biopsy as the reference standard.
III. To determine the proportion of positive transrectal MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous transrectal ultrasound guided biopsy.
IV. To determine the management impact of transrectal MRI-targeted biopsy results as compared to transrectal ultrasound (TRUS)-guided systematic biopsy results.
OUTLINE:
Patients receive gadodiamide intravenously (IV) and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 2 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
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Exclusion Criteria:
Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.
Procedure: 3 Tesla Magnetic Resonance Imaging · Radiation: Gadodiamide · Procedure: Multiparametric Magnetic Resonance Imaging · Procedure: Transrectal Biopsy · Procedure: Ultrasound-Guided Prostate Biopsy
Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
Also known as: 3 Tesla MRI, 3T MRI
Given IV
Also known as: DV 7572, Gadolinium-DTPA-BMA, Gd-DTPA-BMA, HSDB 7547, OmniScan
Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
Also known as: Multiparametric MRI
Undergo transrectal MRI-guided biopsy
Also known as: Transrectal Prostate Biopsy
Undergo TRUS-guided biopsy
Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy
The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.
Time frame: Up to 42 days (6 weeks)
Sensitivity of MRI-guided Biopsy
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
Time frame: Up to 2 weeks after diagnostic MRI
Sensitivity of TRUS-guided Biopsy
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
Time frame: Up to 2 weeks after MRI-guided biopsy
| Milestone | Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy) |
|---|---|
| Started | 2 |
| Completed | 1 |
| Not completed | 1 |
The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.
No measurements were reported for this outcome.
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
No measurements were reported for this outcome.
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy) |
|---|---|
| Female | 0 |
| Male | 2 |
| Region of Enrollment(participants) | Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy) |
|---|---|
| United States | 2 |
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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OHSU Knight Cancer Institute