NCT03679819

Brief Summary

The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

September 5, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

September 17, 2018

Last Update Submit

September 25, 2019

Conditions

Prostate Cancer

Keywords

multiparametric MRIExactVu ultrasound scannerprostatectomy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of high resolution ultrasound

    rate of adequately identified (positive or negative) lesions of prostate cancer

    From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)

Secondary Outcomes (4)

  • Precisions of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer.

    From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)

  • Morphology of lesions not detected by high-resolution ultrasound

    From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)

  • Localization of lesions not detected by high-resolution ultrasound

    From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)

  • Extra-prostatic extensions detected by high-resolution ultra-sound

    From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)

Study Arms (1)

HR-TRUS

HR-TRUS for the detection of prostate cancer in men scheduled for radical prostatectomy for localized prostate cancer

Device: HR-TRUS

Interventions

HR-TRUSDEVICE

Medical procedures to be performed in the study consist of subject preparation and prostate imaging. The HR-TRUS exam will be done with a transrectal probe either the day before surgery, or in the OR right before surgery. The exam will be done in the same manner as during a regular transrectal ultrasound exam and no invasive procedures will be associated.

HR-TRUS

Eligibility Criteria

Age35 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale patients that are diagnosed with localized prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of male patients that are diagnosed with localized prostate cancer by prostate biopsy and that are scheduled for radical prostatectomy as treatment for their disease.

You may qualify if:

  • men \> 35 years age and \<80 years of age
  • diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy
  • staging by standard procedures show localized disease (\<cT4)
  • PSA \< 50ng/ml
  • Access to the rectum for trans rectal ultrasound
  • Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
  • Signed written informed consent prior to any screening procedures being performed

You may not qualify if:

  • Patient with absence of diagnosis of prostate cancer
  • Patient with metastatic prostate cancer
  • Patient with rectal amputation
  • Patient with contraindications for MRI
  • Patient in urgency situation, adult under legal protection, or unable to give his consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

RECRUITING

Related Publications (5)

  • Pavlovich CP, Cornish TC, Mullins JK, Fradin J, Mettee LZ, Connor JT, Reese AC, Askin FB, Luck R, Epstein JI, Burke HB. High-resolution transrectal ultrasound: pilot study of a novel technique for imaging clinically localized prostate cancer. Urol Oncol. 2014 Jan;32(1):34.e27-32. doi: 10.1016/j.urolonc.2013.01.006. Epub 2013 Apr 2.

    PMID: 23558161BACKGROUND

  • Walz J, Marcy M, Maubon T, Brunelle S, Laroche J, Gravis G, Salem N, Bladou F. [Real time elastography in the diagnosis of prostate cancer: comparison of preoperative imaging and histology after radical prostatectomy]. Prog Urol. 2011 Dec;21(13):925-31. doi: 10.1016/j.purol.2011.04.006. Epub 2011 Jun 2. French.

    PMID: 22118357BACKGROUND

  • Ghai S, Eure G, Fradet V, Hyndman ME, McGrath T, Wodlinger B, Pavlovich CP. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016 Aug;196(2):562-9. doi: 10.1016/j.juro.2015.12.093. Epub 2016 Jan 12.

    PMID: 26791931BACKGROUND

  • Boehm K, Salomon G, Beyer B, Schiffmann J, Simonis K, Graefen M, Budaeus L. Shear wave elastography for localization of prostate cancer lesions and assessment of elasticity thresholds: implications for targeted biopsies and active surveillance protocols. J Urol. 2015 Mar;193(3):794-800. doi: 10.1016/j.juro.2014.09.100. Epub 2014 Sep 28.

    PMID: 25264337BACKGROUND

  • Villers A, Puech P, Mouton D, Leroy X, Ballereau C, Lemaitre L. Dynamic contrast enhanced, pelvic phased array magnetic resonance imaging of localized prostate cancer for predicting tumor volume: correlation with radical prostatectomy findings. J Urol. 2006 Dec;176(6 Pt 1):2432-7. doi: 10.1016/j.juro.2006.08.007.

    PMID: 17085122BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jochen Walz, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Genre, MD

CONTACT

(00) 4 91 22 37 78genred@ipc.unicancer.fr

Margot Berline, MSc, MBA

CONTACT

(00) 4 91 22 33 14berlinem@ipc.unicancer.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 20, 2018

Study Start

September 5, 2019

Primary Completion

April 30, 2021

Study Completion

December 31, 2021

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)