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This clinical research study tests the Uronav system. Patients with prostate cancer will be asked to take part in this study.
Uronav system is an investigational device that is used on this study to help place markers in the patient. These are called fiducial markers and they are placed in the patient to help plan radiation treatment. Radiation therapy treatment will be planned by the treating physician and will not be experimental or part of this research study.
This study will also test the similarities and differences of biopsy tissue structures and the findings from the intraprostatic MRI (internally guided MRI).
Study Objectives
Specific Aim 1: Evaluate final pathology post-operatively for histopathology confirmation of multiparametric MRI targets detected during treatment planning. This will be accomplished by using transperineal biopsies obtained prior to interstitial brachytherapy during the procedure, while under anesthetic just prior to the placement of the brachytherapy needles and sources.
Specific Aim 2: Evaluate the ability of the Uronav system in a transperineal setting to guide biopsy needle placement using the electromagnetic guidance system and transperineal ultrasound probe stabilization device and stepper.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uronav | Experimental | Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation. All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uronav guided biopsy | Device | All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI | Number of participants who had biopsies with true positives between biopsy tissue and intraprostatic MRI (sensitivity of the intraprostatic MRI) | Within 15 days of screening |
| Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI | Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI) | Within 15 days of screening |
| Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI | Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI) | Within 15 days of screening |
| Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI | Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI) | Within 15 days of screening |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Infections Within 30 Days | The infection rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of infection compared to standard transrectal biopsies . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Traughber, MD | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34604088 | Derived | Fredman E, Traughber B, Kharouta M, Podder T, Lo S, Ponsky L, MacLennan G, Paspulati R, Ellis B, Machtay M, Ellis R. Focal Prostate Stereotactic Body Radiation Therapy With Correlative Pathological and Radiographic-Based Treatment Planning. Front Oncol. 2021 Sep 15;11:744130. doi: 10.3389/fonc.2021.744130. eCollection 2021. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Uronav | Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation o All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia. Uronav guided biopsy: All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum. Magnetic resonance imaging: An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Uronav | Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation o All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia. Uronav guided biopsy: All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum. Magnetic resonance imaging: An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI | Number of participants who had biopsies with true positives between biopsy tissue and intraprostatic MRI (sensitivity of the intraprostatic MRI) | All participants who were put on study and received treatment | Posted | Count of Participants | Participants | Within 15 days of screening |
|
Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Uronav | Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation o All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia. Uronav guided biopsy: All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum. Magnetic resonance imaging: An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nocturia | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan Traughber | Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | +1 216-884-2516 | bryan.traughber@uhhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2018 | Jun 1, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2018 | May 16, 2019 | ICF_001.pdf |
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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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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
|
| Magnetic resonance imaging | Device | An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study. |
|
|
| Up to 30 days post biopsy |
| Number of Hospitalizations Within 30 Days | The hospitalization rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of hospitalization compared to standard transrectal biopsies . | Up to 30 days post biopsy |
| Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure | The study will be to report the incidence of successful completion of the transperineal biopsy procedure using the Uronav system which is provided by Philips Medical as part of the support for this study | Up to 15 days after screening |
| Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume) | Post-operative radiation dose coverage reported as volumes of prostate receiving a percentage of the prescribed dose, described by mean V100 (% volume) | Up to 15 days after screening |
| Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx) | Dosimetric coverage of brachytherapy implant described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the post-implant prostate volume (given as a percent of the RX dose) | Up to 15 days after screening |
| Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume) | post-operative radiation dose coverage reported as volumes of targeted lesion receiving a percentage of the prescribed dose, described by mean V100 (% Volume) | Up to 15 days after screening |
| Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx) | Dosimetric coverage of target lesion described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the targeted lesion volume (given as a percent of the RX dose) | Up to 15 days after screening |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI | Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI) | All participants who were put on study and received treatment | Posted | Number | biopsies | Within 15 days of screening |
|
|
|
| Primary | Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI | Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI) | All participants who were put on study and received treatment | Posted | Number | biopsies | Within 15 days of screening |
|
|
|
| Primary | Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI | Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI) | All participants who were put on study and received treatment | Posted | Number | biopsies | Within 15 days of screening |
|
|
|
| Secondary | Number of Participants With Infections Within 30 Days | The infection rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of infection compared to standard transrectal biopsies . | All participants who were put on study and received treatment | Posted | Count of Participants | Participants | Up to 30 days post biopsy |
|
|
|
| Secondary | Number of Hospitalizations Within 30 Days | The hospitalization rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of hospitalization compared to standard transrectal biopsies . | All participants who were put on study and received treatment | Posted | Number | hospitilizations | Up to 30 days post biopsy |
|
|
|
| Secondary | Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure | The study will be to report the incidence of successful completion of the transperineal biopsy procedure using the Uronav system which is provided by Philips Medical as part of the support for this study | All participants who were put on study and received treatment | Posted | Count of Participants | Participants | Up to 15 days after screening |
|
|
|
| Secondary | Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume) | Post-operative radiation dose coverage reported as volumes of prostate receiving a percentage of the prescribed dose, described by mean V100 (% volume) | All participants who were put on study and received treatment | Posted | Mean | Standard Deviation | percent | Up to 15 days after screening |
|
|
|
| Secondary | Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx) | Dosimetric coverage of brachytherapy implant described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the post-implant prostate volume (given as a percent of the RX dose) | All participants who were put on study and received treatment | Posted | Mean | Standard Deviation | percent | Up to 15 days after screening |
|
|
|
| Secondary | Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume) | post-operative radiation dose coverage reported as volumes of targeted lesion receiving a percentage of the prescribed dose, described by mean V100 (% Volume) | All participants who were put on study and received treatment | Posted | Mean | Standard Deviation | percent | Up to 15 days after screening |
|
|
|
| Secondary | Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx) | Dosimetric coverage of target lesion described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the targeted lesion volume (given as a percent of the RX dose) | All participants who were put on study and received treatment | Posted | Mean | Standard Deviation | percent | Up to 15 days after screening |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| 5 |
| 5 |
| Cystitis noninfective | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |