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Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Uronav guided biopsy

Magnetic resonance imaging

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Imaging, Prostate, Multiparametric MRI, brachytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Uronav

Arm 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.

Outcomes

Primary Outcome Measures

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)

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)

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)

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)

Secondary Outcome Measures

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 .

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 .

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

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)

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)

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)

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)

Full Information

NCT ID

NCT02681614

First Posted

February 10, 2016

Last Updated

June 29, 2022

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02681614

Brief Title

Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

Official Title

Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

July 21, 2016 (Actual)

Primary Completion Date

January 25, 2018 (Actual)

Study Completion Date

February 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Imaging, Prostate, Multiparametric MRI, brachytherapy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Uronav

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Uronav guided biopsy

Other Intervention Name(s)

Phillips Medical's Uronav

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Magnetic resonance imaging

Other Intervention Name(s)

MRI

Intervention Description

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.

Primary Outcome Measure Information:

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

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

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

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

Secondary Outcome Measure Information:

Title

Number of Participants With Infections Within 30 Days

Description

Time Frame

Up to 30 days post biopsy

Title

Number of Hospitalizations Within 30 Days

Description

Time Frame

Up to 30 days post biopsy

Title

Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure

Description

Time Frame

Up to 15 days after screening

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

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

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

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bryan Traughber, MD

Organizational Affiliation

Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34604088

Citation

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.

Results Reference

derived

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