Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02681614
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 18.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: Uronav guided biopsy; Device: Magnetic resonance imaging	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning
• Actual Study Start Date: Jul 21, 2016
• Actual Primary Completion Date: Jan 25, 2018
• Actual Study Completion Date: Feb 11, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Uronav 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.

Device: 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.; Other Names: Phillips Medical's Uronav ; Device: 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.; Other Names: MRI

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI [Within 15 days of screening]

   Number of participants who had biopsies with true positives between biopsy tissue and intraprostatic MRI (sensitivity of the intraprostatic MRI)

2. Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI [Within 15 days of screening]

   Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI)

3. Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI [Within 15 days of screening]

   Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI)

4. Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI [Within 15 days of screening]

   Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI)

Secondary Outcome Measures

1. Number of Participants With Infections Within 30 Days [Up to 30 days post biopsy]

   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 .

2. Number of Hospitalizations Within 30 Days [Up to 30 days post biopsy]

   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 .

3. Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure [Up to 15 days after screening]

   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

4. Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume) [Up to 15 days after screening]

   Post-operative radiation dose coverage reported as volumes of prostate receiving a percentage of the prescribed dose, described by mean V100 (% volume)

5. Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx) [Up to 15 days after screening]

   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)

6. Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume) [Up to 15 days after screening]

   post-operative radiation dose coverage reported as volumes of targeted lesion receiving a percentage of the prescribed dose, described by mean V100 (% Volume)

7. Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx) [Up to 15 days after screening]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have histopathology confirmed prostate cancer that is Gleason score ≤7(4+3) clinical stage ≤ T2bN0M0 with a Prostate-specific antigen (PSA) below 15 ng/mL.

• Patients must have MRI findings reporting intraprostatic lesions suspicious for malignancy.

• Patient must not have had any prior treatment for prostate cancer

• Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

• Subjects must have an International Prostate Symptom Score of ≤ 15.

• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Gleason score of ≥ 8(4+4)

• PSA ≥ 15 ng/mL.

• Clinical stage >T2b or evidence of nodal

• Patients who are on anticoagulants or high dose aspirin therapy that cannot be safely stopped for greater than 10 days prior to treatment should be excluded to limit increased risk for urinary obstruction.

• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• HIV-positive patients on combination antiretroviral therapy are ineligible because of the unlikely risk of prostate cancer being life threatening in this population.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065

Sponsors and Collaborators

• Case Comprehensive Cancer Center

Investigators

• Principal Investigator: Bryan Traughber, MD, Case Comprehensive Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 6, 2018
• Informed Consent Form - Oct 11, 2018

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02681614
• Other Study ID Numbers: CASE10814
• First Posted: Feb 12, 2016
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Case Comprehensive Cancer Center: Imaging; Prostate; Multiparametric MRI; brachytherapy
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Uronav
Arm/Group Description	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.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Uronav
Arm/Group Description	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.
Overall Participants	5
Age, Customized (Count of Participants)
50-59 years	1 20%
60-69 years	2 40%
70-79 years	2 40%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	5 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	5 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 40%
White	3 60%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	5 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI
Description	Number of participants who had biopsies with true positives between biopsy tissue and intraprostatic MRI (sensitivity of the intraprostatic MRI)
Time Frame	Within 15 days of screening

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Count of Participants [Participants]	2 40%

2. Primary Outcome

Title	Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI
Description	Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI)
Time Frame	Within 15 days of screening

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Number [biopsies]	2

3. Primary Outcome

Title	Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI
Description	Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI)
Time Frame	Within 15 days of screening

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Number [biopsies]	1

4. Primary Outcome

Title	Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI
Description	Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI)
Time Frame	Within 15 days of screening

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Number [biopsies]	2

5. Secondary Outcome

Title	Number of Participants With Infections Within 30 Days
Description	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 .
Time Frame	Up to 30 days post biopsy

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	Number of Hospitalizations Within 30 Days
Description	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 .
Time Frame	Up to 30 days post biopsy

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Number [hospitilizations]	0

7. Secondary Outcome

Title	Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure
Description	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
Time Frame	Up to 15 days after screening

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Count of Participants [Participants]	5 100%

8. Secondary Outcome

Title	Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume)
Description	Post-operative radiation dose coverage reported as volumes of prostate receiving a percentage of the prescribed dose, described by mean V100 (% volume)
Time Frame	Up to 15 days after screening

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Mean (Standard Deviation) [percent]	95.75 (0.03)

9. Secondary Outcome

Title	Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx)
Description	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)
Time Frame	Up to 15 days after screening

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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. 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.
Measure Participants	5
Mean (Standard Deviation) [percent]	111.63 (0.07)

10. Secondary Outcome

Title	Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume)
Description	post-operative radiation dose coverage reported as volumes of targeted lesion receiving a percentage of the prescribed dose, described by mean V100 (% Volume)
Time Frame	Up to 15 days after screening

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Mean (Standard Deviation) [percent]	99.48 (0.01)

11. Secondary Outcome

Title	Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx)
Description	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)
Time Frame	Up to 15 days after screening

Outcome Measure Data

Analysis Population Description

All participants who were put on study and received treatment

Arm/Group Title	Uronav
Arm/Group Description	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.
Measure Participants	5
Mean (Standard Deviation) [percent]	160.83 (0.13)

Adverse Events

Time Frame	Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post
Arm/Group Title	Uronav
Arm/Group Description	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.
All Cause Mortality
	Uronav
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	Uronav
	Affected / at Risk (%)	# Events
Total	1/5 (20%)
Infections and infestations
Sepsis	1/5 (20%)	1
Other (Not Including Serious) Adverse Events
	Uronav
	Affected / at Risk (%)	# Events
Total	5/5 (100%)
Gastrointestinal disorders
Gastroesophageal reflux disease	1/5 (20%)	1
Metabolism and nutrition disorders
Anorexia	1/5 (20%)	1
Renal and urinary disorders
Nocturia	2/5 (40%)	2
Cystitis noninfective	1/5 (20%)	1
Reproductive system and breast disorders
Erectile dysfunction	1/5 (20%)	1
Vascular disorders
Hypertension	1/5 (20%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.