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Per PI, the project start is on suspension.
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The purpose of this study is to utilize this technology in the early detection and staging of pathologic states within prostate cancer patients using the information obtained on mpMRI and serum biomarkers from the patient's blood (if collected). Ultimately, investigators hope to improve the diagnostic accuracy and treatment selection process for these patients. Applying the fusion software which adds mpMRI to ultrasound images in real time, to an otherwise clinically standard but non-targeted ultrasound-guided prostate biopsy procedure will help with accurate and early diagnosis of prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | The experimental conditions will include a standard prostate biopsy using an FDA-approved ultrasound machine with application of the experimental (non-FDA approved) image fusion software. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRUS biopsy | Diagnostic Test | The biopsy procedure will be completed using an FDA-approved ultrasound machine with the addition of an investigational (non-FDA approved) image fusion software. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate investigational fusion software. | To evaluate the sensitivity of the investigational software to aid in targeted biopsy of prostate lesions seen on pre-biopsy mpMRI. | Through study completion, planned 5 year duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess accuracy of mpMRI. | To assess the diagnostic accuracy of Multiparametric Magnetic Resonance Imaging (mpMRI) provided Prostate Imaging Reporting and Data System (PIRADS) with pathology as the reference standard. The research-only procedure of collecting blood will be drawn during the scheduled biopsy visit, using no more than 15 minutes when the subject would already be at the visit. TRUS biopsy is standard of care. Experimental software will be added during the TRUS biopsy, at the time of needle localization. The software performs a computation on the ultrasound machine that fuses the pre-biopsy mpMRI images with the real-time ultrasound images. |
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Inclusion Criteria:
Exclusion Criteria:
Adult male patients undergoing diagnostic work up for suspected or recurrent prostate cancer as standard of care.
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Adult male patients undergoing diagnostic work up for suspected or recurrent prostate cancer as standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| Hina Arif-Tiwari, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Through study completion, planned 5 year duration. |
| Assess sensitivity of software. | To assess the sensitivity of the investigation software in successfully targeting clinically significant prostate cancer, defined as Gleason score of 3+4 or greater. The research-only procedure of collecting blood will be drawn during the scheduled biopsy visit, using no more than 15 minutes when the subject would already be at the visit. TRUS biopsy is standard of care. Experimental software will be added during the TRUS biopsy, at the time of needle localization. The software performs a computation on the ultrasound machine that fuses the pre-biopsy mpMRI images with the real-time ultrasound images. | Through study completion, planned 5 year duration. |
| Correlation of imaging with biomarkers. | To correlate Prostate Imaging Reporting and Data System (PIRADS) score from Multiparametric Magnetic Resonance Imaging (mpMRI) with cellular/ molecular biomarkers of aggressive cancer in the biopsy tissue samples. The research-only procedure of collecting blood will be drawn during the scheduled biopsy visit, using no more than 15 minutes when the subject would already be at the visit. TRUS biopsy is standard of care. Experimental software will be added during the TRUS biopsy, at the time of needle localization. The software performs a computation on the ultrasound machine that fuses the pre-biopsy mpMRI images with the real-time ultrasound images. | Through study completion, planned 5 year duration. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |