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Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer

6 februari 2019 bijgewerkt door: Exact Imaging

This trial uses a ultra high-resolution ultrasound system and specialized transducer, intended for use in prostate imaging. The system's image resolution is significantly better than the standard of care, due to its higher frequency. This allows the system to visualize suspicious areas and structures, and for greater accuracy for guided biopsy.

The primary objective of this study is to demonstrate that ultra high-resolution transrectal ultrasound (UHR-TRUS) is superior to conventional low-resolution transrectal ultrasound (LR-TRUS) in detecting clinically significant cancer among men without known prostate cancer and with an indication for prostate biopsy.

The secondary objective of this study is to compare the difference in the rate of detection of clinically significant cancer between LR-TRUS and UHR-TRUS, from before investigator training to after investigator training.

The tertiary objective for the investigation is to compare the combined sensitivity and specificity in determining cancer detection overall for image-guided biopsy in UHR-TRUS vs. LR-TRUS.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a two-arm multi-centre randomized trial of LR-TRUS versus UHR-TRUS for guided prostate biopsies in men with no known history of prostate cancer. This trial will enroll a minimum of 800 and a maximum of 2000 patients with regular interim analyses to determine the trial's final sample size. These numbers are based on predictive probabilities of trial success.

The investigation is designed as a comparative non-blinded analysis of LR-TRUS vs. UHR-TRUS. Participants will be randomized to either high-resolution or low resolution ultrasound with an equal chance of being in either group. The randomization scheme will be stratified by centre.

When a subject arrives at the institution for his biopsy, the Study Coordinator opens a sealed envelope that indicates to the study participant and physician whether the procedure will be performed using LR-TRUS or UHR-TRUS.

All subjects have an indication for prostate biopsy, and thus, inclusion of a non-treatment group would necessitate a group of men not to receive standard of care. As such, there is no control group in the subject population.

Procedures in the study are:

  • obtaining informed consent for the subject
  • collecting pre-biopsy information and recording it on the case report form (CRF)
  • perform biopsy procedure
  • record biopsy details in CRF
  • prepare biopsy specimens for pathology

Data from CRFs will be stored in a proprietary database that is accessed by a web-based interface, where access is limited to those with login and password. No subject-identifiable information will be entered in the database.

The primary endpoint is the detection of clinically significant prostate cancer, i.e., the number of men with clinically significant prostate cancer determined by pathology review among all men randomized and biopsied. Pathological analysis on 12-core biopsy samples will be the only mechanism used to determine if study subjects have prostate cancer.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1676

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 1P9
        • Prostate Cancer Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Quebec City, Quebec, Canada, G1R 2J6
        • Centre de Recherche sur le Cancer ("CRCEO")
  • Verenigde Staten
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21224
        • Johns Hopkins Brady Urological Institution
    • Virginia
      • Virginia Beach, Virginia, Verenigde Staten, 23452
        • Urology of Virgina

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 79 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  • All men > 40 years age and <80 years of age with an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam).
  • PSA<50
  • Clinical stage < cT3

Exclusion Criteria:

  • Men with a history of prostate cancer
  • Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
  • Men with known prostate volume (from prior imaging) of > 60cc
  • Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
  • Men who are unable to provide their own informed consent

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: LR-TRUS
Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)
Apparaat: Standard ultrasound guided prostate biopsy
Ultrasound guided prostate biopsy using standard of care ultrasound system
Experimenteel: UHR-TRUS
Ultra-high resolution transrectal ultrasound guided prostate biopsy
Apparaat: High-resolution ultrasound guided prostate biopsy
Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
Andere namen:
  • ImagistxProstate Urology Ultrasound System

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Clinically Significant Prostate Cancer
Tijdsspanne: First visit (a patient's involvement in the trial is complete following his biopsy).
Pathology analysis of prostate biopsy is reviewed for indication of clinically significant prostate cancer. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients.
First visit (a patient's involvement in the trial is complete following his biopsy).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training
Tijdsspanne: Pre-training refers to all biopsy procedures occurring between initial training and mid-trial PRI-MUS training. Post-training refers to all biopsy procedures performed after mid-trial PRI-MUS training.
Comparison of pre- and post-training percentage of participants found to harbor clinically significant prostate cancer within the UHR-TRUS arm of the trial
Pre-training refers to all biopsy procedures occurring between initial training and mid-trial PRI-MUS training. Post-training refers to all biopsy procedures performed after mid-trial PRI-MUS training.
Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy
Tijdsspanne: First visit (a patient's involvement in the trial is complete following his biopsy).
Pathology analysis of prostate biopsy is reviewed. Sensitivity of targeted biopsy for each arm will be calculated as the number of targeted biopsy that also found cancer among all targeted biopsies. Specificity of targeted biopsy for each arm will be calculated as the number of non-targeted biopsies that find no cancer among all non-targeted biopsies. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients.
First visit (a patient's involvement in the trial is complete following his biopsy).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Exact Imaging

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2013

Primaire voltooiing (Werkelijk)

1 december 2016

Studie voltooiing (Werkelijk)

1 februari 2018

Studieregistratiedata

Eerst ingediend

3 maart 2014

Eerst ingediend dat voldeed aan de QC-criteria

4 maart 2014

Eerst geplaatst (Schatting)

5 maart 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 februari 2019

Laatste update ingediend die voldeed aan QC-criteria

6 februari 2019

Laatst geverifieerd

1 februari 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2013-UHR-002

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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