Trial Outcomes & Findings for Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning (NCT NCT02681614)

NCT ID: NCT02681614

Last Updated: 2022-06-30

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: Within 15 days of screening
• Results posted on: 2022-06-30

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: Within 15 days of screening

Population: All participants who were put on study and received treatment

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

Outcome measures

Measure

Uronav n=5 Participants 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.

Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI

2 Participants

PRIMARY outcome

Timeframe: Within 15 days of screening

Population: All participants who were put on study and received treatment

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

Outcome measures

Measure

Uronav n=5 Participants 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.

Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI

2 biopsies

PRIMARY outcome

Timeframe: Within 15 days of screening

Population: All participants who were put on study and received treatment

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

Outcome measures

Measure

Uronav n=5 Participants 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.

Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI

1 biopsies

PRIMARY outcome

Timeframe: Within 15 days of screening

Population: All participants who were put on study and received treatment

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

Outcome measures

Measure

Uronav n=5 Participants 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.

Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI

2 biopsies

SECONDARY outcome

Timeframe: Up to 30 days post biopsy

Population: All participants who were put on study and received treatment

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 .

Outcome measures

Measure

Uronav n=5 Participants 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.

Number of Participants With Infections Within 30 Days

0 Participants

SECONDARY outcome

Timeframe: Up to 30 days post biopsy

Population: All participants who were put on study and received treatment

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 .

Outcome measures

Measure

Uronav n=5 Participants 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.

Number of Hospitalizations Within 30 Days

0 hospitilizations

SECONDARY outcome

Timeframe: Up to 15 days after screening

Population: All participants who were put on study and received treatment

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

Outcome measures

Measure

Uronav n=5 Participants 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.

Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure

5 Participants

SECONDARY outcome

Timeframe: Up to 15 days after screening

Population: All participants who were put on study and received treatment

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

Outcome measures

Measure

Uronav n=5 Participants 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.

Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume)

95.75 percent Standard Deviation 0.03

SECONDARY outcome

Timeframe: Up to 15 days after screening

Population: All participants who were put on study and received treatment

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)

Outcome measures

Measure

Uronav n=5 Participants 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.

Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx)

111.63 percent Standard Deviation 0.07

SECONDARY outcome

Timeframe: Up to 15 days after screening

Population: All participants who were put on study and received treatment

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

Outcome measures

Measure

Uronav n=5 Participants 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.

Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume)

99.48 percent Standard Deviation 0.01

SECONDARY outcome

Timeframe: Up to 15 days after screening

Population: All participants who were put on study and received treatment

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)

Outcome measures

Measure

Uronav n=5 Participants 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.

Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx)

160.83 percent Standard Deviation 0.13

Adverse Events

Uronav

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure

Uronav n=5 participants at risk 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.

Infections and infestations Sepsis

20.0% 1/5 • Number of events 1 • Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post

Other adverse events

Measure	Uronav n=5 participants at risk 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.
Renal and urinary disorders Nocturia	40.0% 2/5 • Number of events 2 • Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post
Renal and urinary disorders Cystitis noninfective	20.0% 1/5 • Number of events 1 • Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post
Gastrointestinal disorders Gastroesophageal reflux disease	20.0% 1/5 • Number of events 1 • Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post
Metabolism and nutrition disorders Anorexia	20.0% 1/5 • Number of events 1 • Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post
Reproductive system and breast disorders Erectile dysfunction	20.0% 1/5 • Number of events 1 • Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post
Vascular disorders Hypertension	20.0% 1/5 • Number of events 1 • Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post

Additional Information

Bryan Traughber

Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Phone: +1 216-884-2516

Email: bryan.traughber@uhhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place