Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

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.

MRI guided biopsy

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.

TRUS biopsy

Lee Ponsky, MD

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:

1. To develop advanced MRI methods and optimal MRI protocols for detection, staging, and follow-up of prostate cancer.
2. To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI findings with the pathological grade of cancer.
3. To correlate prostate MRI findings and biopsy results with patient progress and outcomes.
4. To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on active surveillance.

Secondary Objectives:

1. To apply computer-aided advanced image analytic techniques (Computer-assisted diagnostics- CAD) to extract MRI features of patient clinical scans that correlate with diagnosis and grade of prostate cancer.
2. To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes.
3. To evaluate the impact of MRI in decision making and choice of treatment by physicians and patients.

Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer

Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer

Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant

1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant

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

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.

Case Comprehensive Cancer Center

Behaviors and Mental Disorders

Adenocarcinoma

Aggression

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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.

The biopsy procedure will be completed using an FDA-approved ultrasound machine with the addition of an investigational (non-FDA approved) image fusion software.

Hina Arif-Tiwari, MD

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.

Adult male patients undergoing diagnostic work up for suspected or recurrent prostate cancer as standard of care.

Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy

Improved Detection and Localization Accuracy of Early Aggressive Prostate Adenocarcinoma Using Novel MR-directed Ultrasound-guided (MRdUSg) Prostate Biopsy Technique

To evaluate the sensitivity of the investigational software to aid in targeted biopsy of prostate lesions seen on pre-biopsy 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.

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.

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.

University of Arizona

TRUS and TRUS-Robot will be used during prostate biopsy

Just Uronav will be used during prostate biopsy

A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.

TRUS-Robot

Misop Han, M.D., M.S.

Dan Stoianovici, PhD

Misop Han, M.D.

Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).

This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Number of biopsy patients diagnosed with Gleason score \>= 7 over the total number of patients on both arms of the study.

Serious adverse events will be assessed according to 21 Code of Federal Regulations (CFR) Part 812.3(s).

Number of biopsy patients diagnosed with Gleason score \<= 6 over the total number of patients on both arms of the study.

Needle targeting errors will be measured as the distance between the planned core center and the inserted needle axis. Targeting accuracy will be calculated as the average of the needle targeting errors, as usual.

The time of the actual biopsy procedure measured in minutes.

Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate sensitivity.

Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate specificity.

Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate predictive rates.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer	NCT03122470	Prostate Cancer	MRI guided biop... TRUS biopsy	40 Years - 90 Years	Case Comprehensive Cancer Center
Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer	NCT03122470	Prostate Cancer	MRI guided biop... TRUS biopsy	40 Years - 90 Years	Case Comprehensive Cancer Center
Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy	NCT05064111	Prostate Cancer Prostate Adenoc...	TRUS biopsy	18 Years -	University of Arizona
Transrectal Ultrasound Robot-Assisted Prostate Biopsy	NCT02871726	Prostate Cancer	TRUS-Robot TRUS biopsy	45 Years - 75 Years	Johns Hopkins University
Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer	NCT03122470	Prostate Cancer	MRI guided biop... TRUS biopsy	40 Years - 90 Years	Case Comprehensive Cancer Center
Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy	NCT05064111	Prostate Cancer Prostate Adenoc...	TRUS biopsy	18 Years -	University of Arizona

Spots Global Cancer Trial Database for trus biopsy

Every month we try and update this database with for trus biopsy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for trus biopsy

Every month we try and update this database with for trus biopsy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for trus biopsy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.