Prostate CancerNCT02681614

Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

A study testing Uronav guided biopsy and Magnetic resonance imaging in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Uronav guided biopsy and Magnetic resonance imaging
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 21 Jul 2016to 11 Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

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).

Read the 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.

Conditions: Prostate Cancer
Being tested: Uronav guided biopsy, Magnetic resonance imaging
Keywords: Imaging, Prostate, Multiparametric MRI, brachytherapy
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Uronav guided biopsyDevice
Also called Phillips Medical's Uronav
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 imagingDevice
Also called MRI
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.

Study groups in NCT02681614
Study group	Role	What they receive
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. Receives: Device: Uronav guided biopsy; Device: Magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Within 15 days of screening

Secondary outcomes (7)

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 .
Measured: 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 .
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to 15 days after screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 201611 Feb 2018

First posted12 Feb 2016 (estimated)
Study start21 Jul 2016
Primary completion25 Jan 2018
Study completion11 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02681614
Sponsor's protocol ID: CASE10814
Status last verified: Jun 2022
First submitted: 10 Feb 2016
Last updated: 30 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 34604088

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning
ClinicalTrials.gov ID: NCT02681614
Acronym / sponsor ID: CASE10814
Conditions: Prostate Cancer
Keywords: Imaging, Prostate, Multiparametric MRI, brachytherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Study start: 21 Jul 2016 (actual)
Primary completion: 25 Jan 2018 (actual)
Study completion: 11 Feb 2018 (actual)
First posted: 12 Feb 2016 (estimated)
Results: Posted 14 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This clinical research study tests the Uronav system. Patients with prostate cancer will be asked to take part in this study.

This study will also test the similarities and differences of biopsy tissue structures and the findings from the intraprostatic MRI (internally guided MRI).

Detailed description

Study Objectives

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Uronav	Experimental	Device: Uronav guided biopsy, Device: Magnetic resonance imagingParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Uronav guided biopsyAlso: Phillips Medical's UronavAll 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.	Device	Uronav
Magnetic resonance imagingAlso: MRIAn 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.	Device	Uronav

Primary outcome

Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI
Time frame: 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)
Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI
Time frame: Within 15 days of screening
Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI)
Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI
Time frame: Within 15 days of screening
Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI)
Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI
Time frame: Within 15 days of screening
Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI)

7 secondary outcomes

Number of Participants With Infections Within 30 Days
Time frame: Up to 30 days post biopsy
Number of Hospitalizations Within 30 Days
Time frame: Up to 30 days post biopsy
Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure
Time frame: Up to 15 days after screening
Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume)
Time frame: Up to 15 days after screening
Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx)
Time frame: Up to 15 days after screening
Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume)
Time frame: Up to 15 days after screening
Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx)
Time frame: Up to 15 days after screening

Results and safety

Results posted to the registry on 14 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Uronav	5	5

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

Time frame: Within 15 days of screening. Count of participants. Unit: Participants

Measure	Uronav n = 5
Value	2

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

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

Time frame: Within 15 days of screening. Number. Unit: biopsies

Measure	Uronav n = 5
Value	2

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

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

Time frame: Within 15 days of screening. Number. Unit: biopsies

Measure	Uronav n = 5
Value	1

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

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

Time frame: Within 15 days of screening. Number. Unit: biopsies

Measure	Uronav n = 5
Value	2

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

7 secondary outcomes are reported in the full results.

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. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Uronav	1 of 5 (20%)	5 of 5 (100%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34604088Fredman 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bryan Traughber, MD principal investigator

Case Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Uronav guided biopsy and Magnetic resonance imaging in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI (time frame: Within 15 days of screening). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02681614, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.