NCT04299620

Brief Summary

This trial studies the ability of micro-ultrasound to detect and characterize prostate cancer tumors in patients undergoing radical prostatectomy (removal of the entire prostate and some of the tissue around it). Usually multiparametric magnetic resonance imaging is used for the detection and targeted therapy of prostate cancer, but its accuracy remains imperfect. Micro-ultrasound may be superior as it provides real-time tumor visualization which may simplify and improve prostate cancer targeted therapy. This may also reduce the need for and substantial costs of radical prostatectomy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 21, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

February 19, 2020

Last Update Submit

October 4, 2023

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Identification of prostate cancer foci

    Will be evaluated by comparing sensitivity and positive predictive value of multiparametric magnetic resonance imaging (mpMRI) and micro-ultrasound (US) for identification of prostate cancer (CaP) foci. Measurement tool = chi squared test

    Up to 3 years

Secondary Outcomes (1)

  • Contours of prostate cancer foci

    Up to 3 years

Other Outcomes (2)

  • Ex vivo and in vivo micro-US images

    Up to 3 years

  • Suspicion of extracapsular extension (ECE)

    Up to 3 years

Study Arms (1)

Diagnostic (TRUS)

EXPERIMENTAL

Patients may undergo TRUS prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.

Device: Digital Image AnalysisProcedure: Radical ProstatectomyProcedure: Transrectal Ultrasound

Interventions

Digital Image AnalysisDEVICE

Analysis of images

Diagnostic (TRUS)
Radical ProstatectomyPROCEDURE

Undergo standard of care radical prostatectomy

Also known as: Prostatovesiculectomy
Diagnostic (TRUS)
Transrectal UltrasoundPROCEDURE

Undergo transrectal ultrasound

Also known as: endorectal ultrasound, ERUS (endorectal ultrasound), TRUS
Diagnostic (TRUS)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Standard-of-care mpMRI within the past 12 months
  • Biopsy-proven prostate cancer, Gleason grade \>= 3+3
  • Maximum posterior-to-anterior prostate dimension of =\< 6 cm
  • Scheduled to receive standard-of-care radical prostatectomy

You may not qualify if:

  • Maximum posterior-to-anterior prostate dimension greater than 6 cm
  • Prior radiation or focal treatment for prostate cancer
  • Inability to have a transrectal ultrasound scan
  • Prostate biopsy \< 4 weeks prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ultrasound, High-Intensity Focused, Transrectal

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound AblationUltrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsAblation TechniquesSurgical Procedures, OperativeProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Leonard S Marks

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2020

First Posted

March 9, 2020

Study Start

October 21, 2020

Primary Completion

June 14, 2022

Study Completion

September 1, 2025

Last Updated

October 6, 2023

Record last verified: 2022-10

Locations

US(1)