Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PI departure - study not conducted.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. The results of the MRI will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.
The study team hypothesizes that strategic use of advanced MRI methods will provide a more accurate and less invasive approach for diagnosis and management of prostate cancer. The primary objectives are:
Secondary Objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI guided biopsy + TRUS biopsy | Experimental | Patients will undergo an MRI guided biopsy and standard trans-rectal ultrasonography-guided (TRUS) biopsy. Results will be compared to see which can more accurately diagnose and manage prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI guided biopsy | Device | The MRI guided biopsy will preferentially be performed using a 3 tesla (3T) Siemens Verio, or 3T Siemens Skyra machine. The multiparametric MRI exam will consist of T1-, T2- and diffusion weighted imaging with or without post-contrast perfusion studies. magnetic resonance fingerprinting (MRF) will be performed before contrast injection. The MRI will be interpreted by two specified radiologists from the research team. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with the most likely diagnosis based on the five-point scale - PIRADS | Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant | Up to two weeks after MRI |
| Number of patients with true diagnosis based on biopsy pathology | 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant | Up to two weeks after MRI |
| Measure | Description | Time Frame |
|---|---|---|
| biopsy and MRI based diagnosis match in at least 8/10 patients | The score based on the true diagnosis and most likely diagnosis as agreed on by classifiers is the same in at least 80% of patients | Up to two weeks after MRI |
| Ratio of positive diagnosis as detected by pelvic MRI guided biopsy compared to standard TRUS biopsy |
Not provided
Inclusion Criteria:
Inclusion criteria for sub-group follow-up scans:
1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lee Ponsky, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| TRUS biopsy | Procedure | The TRUS biopsy will be performed per current standard of care. Biopsy cores will be sent to pathology in separately labeled specimen cups. The final pathological results will be compared with pre-biopsy MRI findings. |
|
|
The diagnostic performance of MRI guided biopsy techniques will be compared with standard TRUS biopsy using a single sample of patients undergoing both biopsy techniques. It has been reported that MRI consistently detects a larger number of clinically significant prostate cancers (sensitivity - 0.91 for MRI-guided biopsy vs 0.76 for TRUS biopsy), while avoiding the detection of cancers that are clinically insignificant, as compared to TRUS biopsy. |
| Up to two weeks after MRI |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |