Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer in Adult Men With Suspected Prostate Cancer

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

ultiparametric Magnetic Resonance Imaging

Perflutren lipid microsphere

Transrectal Ultrasound

Biopsy of Prostate

About this trial

This is an interventional diagnostic trial for Prostate Carcinoma

Eligibility Criteria

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

Inclusion Criteria: Subject must be scheduled for a prostate biopsy, based on an elevated PSA (> 3.0ng/ml) per most recent National Comprehensive Cancer Network (NCCN) guidelines, elevated PSA velocity (> 0.75ng/ml/year), or abnormal digital rectal examination Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate including the additional study biopsies Subject must be a male at least 18 years of age when informed consent is obtained Exclusion Criteria: Participant in a clinical trial involving an investigational drug within the past 30 days Patients with known or suspected hypersensitivity to perflutren, polyethylene glycol (PEG), or any other component of Definity Previous treatment for prostate cancer, including hormone therapy Clinically unstable, severely ill, or moribund as per treating physician

Sites / Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)

Arm Description

Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.

Outcomes

Primary Outcome Measures

Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy

Will compare PCa detection rate of 3D mp-US combined with systematic biopsy to detection rate of multiparametric magnetic resonance imaging (mp-MRI) combined with systematic biopsy. Will evaluate paired biopsy data for non-inferiority and superiority endpoints, comparing the detection rate of clinically significant PCa with mp-US + systematic biopsy to the detection rate of mp-MRI + systematic biopsy. This analysis will be repeated using both definitions of clinically significant PCa. Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, standard deviation (SD), median, and range.

Secondary Outcome Measures

PCa detection rate of 3D mp-US

Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, SD, median, and range. Continuous data will be analyzed using t-tests, or log-rank tests if data are not normally distributed. Variance is expressed through 95% confidence intervals and a significance level of 5% with Bonferroni correction for multiple comparisons will be used to control the group-wise error of the study for individual comparisons.

Accuracy of PCa detection by biopsy using the optimal logistical model based around mp-US compared to the optimal logistical model based around mp-MRI

Will evaluate the accuracty of the optimal logistic model combining the mp-US elements as well as the prostate specific antigen, prostate specific antigen velocity and other biological variables.

Full Information

NCT ID

NCT06024772

First Posted

August 18, 2023

Last Updated

August 29, 2023

Sponsor

Thomas Jefferson University

1. Study Identification

Unique Protocol Identification Number

NCT06024772

Brief Title

Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer in Adult Men With Suspected Prostate Cancer

Official Title

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

August 1, 2025 (Anticipated)

Study Completion Date

February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase III trial compares the use of contrast-enhanced multiparametric ultrasound (mp-US) to multiparametric magnetic resonance imaging (mp-MRI) for the diagnosis of clinically significant prostate cancer (PCa). A mp-US is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Perflutren lipid michrosphere (Definity) is a contrast agent that uses microbubbles to enhance ultrasound images of the prostate. Doctors hope to learn if the Definity-enhanced mp-US imaging technique can accurately direct targeted biopsy for the detection of clinically significant prostate cancer when compared to standard of care mp-MRI.

Detailed Description

PRIMARY OBJECTIVE: I. To demonstrate non-inferiority between the detection rate of clinically significant PCa with 3-dimensional (3D) mp-US + systematic biopsy compared to the detection rate of mp-MRI + systematic biopsy. SECONDARY OBJECTIVES: I. To demonstrate non-inferiority of a biopsy approach utilizing targeted biopsy cores based on mp-US compared with targeted biopsy based on mp-MRI, for detection of clinically significant PCa. II. To construct an optimal logistic regression model to predict the presence of clinically significant PCa based on the mp-US elements as well as the prostate specific antigen (PSA), PSA velocity and any other biological variables (e.g., age). OUTLINE: Patients undergo mp-MRI, receive Definity intravenously (IV), and undergo transrectal mp-US and prostate biopsies on study.

6. Conditions and Keywords

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

Prostate Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)

Arm Type

Experimental

Arm Description

Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.

Intervention Type

Procedure

Intervention Name(s)

ultiparametric Magnetic Resonance Imaging

Other Intervention Name(s)

MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

Intervention Description

Undergo mp-MRI

Intervention Type

Drug

Intervention Name(s)

Perflutren lipid microsphere

Other Intervention Name(s)

Definity

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Transrectal Ultrasound

Other Intervention Name(s)

endorectal ultrasound, ERUS, TRUS

Intervention Description

Undergo transrectal mp-US

Intervention Type

Procedure

Intervention Name(s)

Biopsy of Prostate

Other Intervention Name(s)

Prostate Biopsy, Prostatic Biopsy

Intervention Description

Undergo prostate biopsies

Primary Outcome Measure Information:

Title

Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy

Description

Will compare PCa detection rate of 3D mp-US combined with systematic biopsy to detection rate of multiparametric magnetic resonance imaging (mp-MRI) combined with systematic biopsy. Will evaluate paired biopsy data for non-inferiority and superiority endpoints, comparing the detection rate of clinically significant PCa with mp-US + systematic biopsy to the detection rate of mp-MRI + systematic biopsy. This analysis will be repeated using both definitions of clinically significant PCa. Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, standard deviation (SD), median, and range.

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

PCa detection rate of 3D mp-US

Description

Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, SD, median, and range. Continuous data will be analyzed using t-tests, or log-rank tests if data are not normally distributed. Variance is expressed through 95% confidence intervals and a significance level of 5% with Bonferroni correction for multiple comparisons will be used to control the group-wise error of the study for individual comparisons.

Time Frame

Up to 2 years

Title

Accuracy of PCa detection by biopsy using the optimal logistical model based around mp-US compared to the optimal logistical model based around mp-MRI

Description

Will evaluate the accuracty of the optimal logistic model combining the mp-US elements as well as the prostate specific antigen, prostate specific antigen velocity and other biological variables.

Time Frame

Up to 2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Subject must be scheduled for a prostate biopsy, based on an elevated PSA (> 3.0ng/ml) per most recent National Comprehensive Cancer Network (NCCN) guidelines, elevated PSA velocity (> 0.75ng/ml/year), or abnormal digital rectal examination Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate including the additional study biopsies Subject must be a male at least 18 years of age when informed consent is obtained Exclusion Criteria: Participant in a clinical trial involving an investigational drug within the past 30 days Patients with known or suspected hypersensitivity to perflutren, polyethylene glycol (PEG), or any other component of Definity Previous treatment for prostate cancer, including hormone therapy Clinically unstable, severely ill, or moribund as per treating physician

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Flemming Forsberg, PhD

Phone

215-955-4870

Email

Flemming.Forsberg@jefferson.edu

Facility Information:

Facility Name

Sidney Kimmel Cancer Center at Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Flemming Forsberg, PhD

Phone

215-955-4870

Email

Flemming.Forsberg@jefferson.edu

Prostate Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial