Prostate Adenocarcinoma, Prostate Cancer
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTTRUS biopsy
The biopsy procedure will be completed using an FDA-approved ultrasound machine with the addition of an investigational (non-FDA approved) image fusion software.
Sponsors
University of Arizona
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to give informed consent 2. Male - age \> 18 3. mpMRI within the previous 6 months (PIRADS 3,4,5, all stages of PCa) 4. Scheduled for TRUS biopsy for prostate lesion or mass
Exclusion criteria
1. Age under 18 years of age. 2. Female 3. Pre-existing blood dyscrasias 4. Inability to perform TRUS due to anal sphincter closure/surgery 5. Patients needing general anesthesia 6. Patients allergic to lidocaine 7. Patients allergic or unable to take antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate investigational fusion software. | Through study completion, planned 5 year duration. | To evaluate the sensitivity of the investigational software to aid in targeted biopsy of prostate lesions seen on pre-biopsy mpMRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess accuracy of mpMRI. | Through study completion, planned 5 year duration. | 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. |
| Assess sensitivity of software. | Through study completion, planned 5 year duration. | 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. |
| Correlation of imaging with biomarkers. | Through study completion, planned 5 year duration. | 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. |
Countries
United States
Outcome results
None listed