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

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Anesthetics

Ciprofloxacin

All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.

The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.

UreScan

Thomas E Ahlering, MD

This study is being performed to verify the ability to use minimally invasive transurethral ultrasonic imaging technology for the purpose of identifying prostate cancer. Transurethral ultrasonic prostate imaging, may in the future, be used for detection and monitoring these disease processes to minimize the need for obtaining surgical biopsy specimens. The hypothesis is that tissue-density variations, as revealed in diagnostic ultrasonic imaging, results in unique image signatures for identification of prostate cancer. This imaging procedure provides a multifaceted view of the entire in-situ gland.

The current use of Prostate Specific Antigen (PSA) for determining the likelihood of presence of cancer in the prostate gland requires interpretation and has a good but limited to predict prostate cancer on biopsy, with significant false prediction rates. More importantly as a blood test, the PSA test lacks the ability to pinpoint the location of the cancer within the prostate gland. Preliminary study findings have suggested that "Transurethral Ultrasonic Scanning" (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer within the imaged prostate gland, and has the intrinsic capability to provide high resolution images of the transverse and future three-dimensional views of the entire gland better than currently used Transurethral Ultrasound (TRUS). Two important goals of the practicality of this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to directly detect prostate cancer locations in the prostate. 2. The use of TUUS to successfully guide the prostate needle biopsy to cancer loci with a high rate accuracy.

The Purpose of the Research The primary objective of this Institutional Review Board-controlled study is to determine if the presently manually-read results of TUUS data obtained with the novel UreScan device can be correlated with pathologist findings in a harvested prostate gland from an individual with diagnosed prostate disease. If successful, a future Institutional Review Board study will explore the use of computer software to examine the 256 transverse image slices of a large number of prostate cancer patients to establish the clinical applicability of TUUS for screening and assessment of individuals with elevated levels of PSA and/or positive digital rectal examinations (DRE), potentially reducing the number of future biopsy examinations with false-positive findings.

Background Information The current use of Prostate Specific Antigen for determining the likelihood of presence of cancer in the prostate gland has been shown to be seriously flawed. Multiple studies reviewing the findings of referred biopsies, based on elevated PSA levels, resulted in as many as 70% false positive findings for cancer. Improved rapid, minimally-invasive, low-cost methodology and technology should be developed to provide diagnostic cancer findings that have higher sensitivity and specificity is the objective goal of the present research. Preliminary study findings have suggested that "Transurethral Ultrasonic Scanning" (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer within the imaged prostate gland and has the intrinsic capability to provide high resolution images of the transverse and future three-dimensional views of the entire gland. Two important goals of this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to directly detect prostate cancer in situ in the prostate. 2. The use of TUUS to successfully guide the prostate needle biopsy to cancer loci with a high rate accuracy.

In a 2003 study by Holmes et al, the TUUS device was tested on 2 patients who had seeds implanted for prostate cancer. TUUS revealed more seeds (82%, 84%) than standard TRUS (63%, 65%) in the 2 patients. These simple cases demonstrated the feasibility of providing transverse images of the entire prostate gland. Holmes postulated that this procedure would have to be automated to achieve any clinical utility value and the project essentially was abandoned by Mayo.

The TUUS/"UreScan" system is a marriage of an off label usage of the FDA approved vascular probe, placed inside a standard foley catheter which is inserted into the penis onto the prostate to the neck of the bladder. The ultrasound probe travels the length of the prostate (\~4-8cm) within the sheath of the catheter and images the entire prostate with ultrasound. The travel of the ultrasound probe is controlled by a small motor which is driven from outside the catheter and patient as well. This motor driven probe offers the possibility of accurate and reproducible ultrasounds of the prostate, as the patient's prostate apex is used the anchor point for study.

Refinements to the TUUS system include:

1. A Foley type introducer should be used for placing the intravascular ultrasound transducer in the prostatic urethral region to be imaged
2. Use of a fixed-position, ultrasonic coupling gel-coated Introducer to eliminate the possibility of urethral abrasion or trauma as might otherwise occur without the Introducer when moving the transducer within the prostatic imaging region.
3. Insertion into the Introducer of the wire-rotationally-driven ultrasonic transducer as coated with sterile water ultrasonic coupling between the transducer and introducer
4. The examiner would then initiate the automated scanning procedure with analog/digital video data for each of 256 transverse axial image slices of the prostate gland. The scanning of the gland can be stopped or started at the election of the examiner
5. A video-media record of the images derived from the procedure is available to an experienced reader for interpretation.

The initial UreScan hydrophone verified specifications included: 1. 256 transverse, automatically axially advanced, image slices. 2. Approximately 267 megabits of video data. 3. Diagnostic ultrasound scanning of 100 revolutions per minute at 9.0 M Megahertz. 4. Radial penetration of 6 cm. The scanner features:

1. The amplitude of reflected ultrasonic echoes from biological tissue, as displayed by a density-based oscillogram is directly proportional to the density of the tissue being insonated in an adjusted flat far-gain ultrasonic system.
2. Longitudinal time-related, ultrasonic densitometry and image-registered comparisons of sonograms have demonstrated progression and/or regression of disease consistent with efficacy of treatment procedures. This facilitates future "wait and watch surveillance" of known or suspected lesions while potentially minimizing and/or eliminating unnecessary surgical biopsy tissues procedures
3. The reflected echo waveform and sonogram has been shown to be unique for each type of disease entity. In prostate disease, there is a unique difference between the image-markers for prostate cancer and normal tissue.

The present study protocol is to determine if image-markers for cancer and other unique prostate pathology can be specifically identified. Further clinical studies will be required to determine sensitivity, specificity, accuracy and (+/-) predictor values of this procedure. Additional studies will be required to determine if the amplitude of the image-markers could be used for determining the approximate stage of the image detected disease processes.

Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer

The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis

University of California, Irvine

Vice Chairman and Professor

All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.

UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.

All Patients

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Thomas Ahlering, MD

Data were not collected because the study was discontinued due to lack of feasibility and negative results.

Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer

Overall Study

Symptoms and General Pathology

Prostatic Hyperplasia

Hyperplasia

First, it will be validated on 120 anesthetized patients undergoing prostate surgery comparing responses on the digital rectal exam clinical tool (DiRECT) from both expert and novice clinicians, with surgical pathology reports.

During a standardized patient exercise focusing on digital rectal exam in the University of Virginia School of Medicine curriculum, 160 second-year medical students will be given the DiRECT to document their examination. An attending physician will also attend the standardized patient exercise and document their examination for comparison with the medical students.

The third phase includes 8 residents and up to10 attendings in the Urology clinic, who will independently complete the DiRECT documenting their DRE in the course of usual care.

The DRE digital rectal exam is an essential component of physical examination, but physicians enter their residency having neither been appropriately exposed nor trained in performing DREs. , the attending physician, resident physician(s), and medical student(s) will each perform a digital rectal exam on the subject, and independently document their examination on the DiRECT instrument.

Digital Rectal Exam

Tracey L Krupski, M.D.

Patricia Battle, LPN, CRC

Raymond A Costabile, M.D.

A digital rectal exam proficiency tool, titled the 'DiRECT' was developed based on the consensus of 10 experts. The purpose of this study is to validate this tool for use in both undergraduate and graduate medical education .

First, it will be validated on 120 anesthetized patients undergoing prostate surgery, comparing responses on the digital rectal exam clinical tool (DiRECT) from both expert and novice clinicians, with surgical pathology reports. The second phase of validation will involve the participation of standardized patients, medical students and MUTA (medical urology teaching associate). During a standardized patient exercise focusing on digital rectal exam in the University of Virginia School of Medicine curriculum, 160 second-year medical students will be given the DiRECT to document their examination. An attending physician will also attend the standardized patient exercise and document their examination for comparison with the medical students.

The third phase includes 8 residents and up to10 attendings in the Urology clinic, who will independently complete the DiRECT documenting their DRE in the course of usual care.

Comparison of faculty and student/trainee responses in all phases will be used for validation of the clinical tool for further use in medical education.

Digital Rectal Exam Proficiency Tool

Validation of the DiRECT Proficiency Tool

University of Virginia

M.D. Associate Professor of Urology

Recurrence

Adenocarcinoma

Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months.

stereotactic radiosurgery

magnetic resonance imaging

Quality of life scores will be summarized graphically and repeated measures of variance will be conducted to test for changes in scores over time

quality-of-life assessment

Test of the PSA protein in blood. The test will be run every three months for up to two years during the study.

Serum Prostate Antigen Test

Exam of rectal health. Performed every three months for up to two years throughout the study.

This survey measures a patient's function and bother after prostate cancer treatment. It will be analyzed using ANOVA using data collected every 6 months for up to 2 years of the study.

Expanded Prostate Cancer Index Composite

Elisha Fredman, MD

This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. Evaluate the correlation of histopathology findings in comparison to regions of the prostate reported to be suspicious for harboring tumor burden on multiparametric MRI report/s.

II. Demonstration of the dosimetric and radiobiological advantages of focal stereotactic body radiation therapy (SBRT) versus whole-gland radiation therapy.

III. Evaluation of clinical outcomes in focal SBRT for localized prostate cancer.

OUTLINE:

Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months.

After completion of study treatment, patients are followed up every 3 months for up to 24 months.

Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer

Number of patients with change in EPIC bowel domain score that was worse than 5 points

A rate for the worse-than-5 point change in bowel score of up to 35% of patients will be considered acceptable, with a rate ≥55% specified as unacceptable

Number of patients with change in EPIC urinary domain score that was worse than 2 points

A rate for the worse-than-2 point change in urinary score of up to 40% will be considered acceptable, with a rate ≥60% unacceptable

Number of patients with PSA failure. Failure occurs when the PSA is first noted to be 2 ng/mL or more than the patient's nadir value post radiation therapy completion

Defined as the first occurrence of worst severity of the adverse event =\< 30 days after the completion of radiation therapy. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram.

Defined as the first occurrence of worst severity of the adverse event =\< 30 days after the completion of radiation therapy.

Defined as the first occurrence of worst severity of adverse event \> 180 days after radiation therapy completion. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram.

Defined as the first occurrence of worst severity of adverse event \> 180 days after radiation therapy completion.

Defined as From the date of treatment to the date of documentation of disease progression or until the date of death from any cause. Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Also, 95% confidence intervals will be reported. Descriptive reports of Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) and volumetric findings will be provided.

Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Descriptive reports of RECIST (1.1) and volumetric findings will be provided. Time will be reported in months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer	NCT02307552	Prostate Cancer	UreScan	40 Years - 80 Years	University of California, Irvine
Digital Rectal Exam Proficiency Tool	NCT02278679	Prostatic Hyper... Prostate Cancer	Digital Rectal ...	30 Years - 90 Years	University of Virginia
Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer	NCT02163317	Adenocarcinoma ... Recurrent Prost... Stage I Prostat... Stage IIA Prost... Stage IIB Prost...	stereotactic ra... magnetic resona... quality-of-life... Serum Prostate ... Digital Rectal ... Expanded Prosta...	18 Years -	Case Comprehensive Cancer Center

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