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Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate.

2 december 2019 bijgewerkt door: Dr. Jason Izard, Department of Urology, Queen's University

Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate: The Safety and Feasibility of a Novel Method of Prostate Biopsy.

The purpose of this study is to investigate a novel method of prostate biopsy using a computerized guidance system to accurately target lesions within the prostate. This method of prostate biopsy involves using a computerized technology that permits a lesion detected on MRI to be projected by a computer into 3 dimensions on a patient's CT scan. A CT guided biopsy can then be performed where a needle is advanced into the patient, where the computer has projected the image of the tumor that cannot normally be seen on CT. This is a randomized, cross over designed trial to compare this new method of prostate biopsy to the currently employed standard transrectal ultrasound guided prostate (TRUSP) biopsy technique.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This will be a prospective randomized controlled trial using a cross over design. Patients will serve as their own controls and undergo both TRUSP biopsy (standard of care) and mpMRI fused to cone beam CT guided biopsy of the prostate. The procedures and recovery will follow the identical standardized care pathway that is currently used for TRUSP biopsies. A total of 20 patients will be recruited

Patients will be randomized to receive either TRUSP biopsy or cone beam CT guided biopsy first, followed by the alternative procedure. Following the initial biopsy procedure the patients will fill out a short pain score. They will then recover in the radiology suite for a period of one hour. Following a one hour recovery period the patient will subsequently undergo the alternative biopsy procedure. They will then fill out a second pain score with two additional questions asking the patient to compare the two biopsy approaches with respect to comfort and preference using a 7 point Likert scale. Specimens will be sent to pathology separately to detect differences in diagnostic yield between the two biopsy approaches. In order to minimize inter-operator variability in outcomes, Dr. Menard will perform all biopsies regardless of approach.

An interim analysis after 10 patients will be performed. The study will be terminated early if:

  1. No TRUSP biopsy detects any form of prostate cancer
  2. No cone beam CT guided biopsy detects any form of prostate cancer.
  3. Average pain scores between biopsy approaches differ by more than 4 points on the Universal Pain Assessment scale.

  4. 3 or more patients suffer any of:

    1. Immediate procedure related complications
    2. 30 day return to the emergency room
    3. 30 day hospital admission

Measures

Feasibility:

Patients will be considered to have clinically significant prostate cancer based on their PI-RADS score 4 or 5. The ability of TRUSP biopsy and cone beam CT guided biopsy to detect any form of prostate cancer as well as clinically significant prostate cancer (defined as prostate cancer with a Gleason score ≥7) will serve as the primary outcome measures.

Safety:

Immediate procedure related complications, 30 day return to the ER and 30 day hospital admission rates will be recorded. Immediate procedure related complications will be documented at the time of the procedure. The 30 day return to the ER and hospital admission rates will be documented at the participant's followup appointment. Complication rates will reflect the total combined complication rate. This can be compared against the known Ontario province rates to ensure that the addition of cone beam CT guided biopsy does not provide for additive morbidity.

Tolerability:

Patients will fill out the Universal Pain Assessment Tool after each procedure. After both procedures are completed, patients will fill out two questions utilizing a 7 point Likert scale on preference and comfort between the two biopsy approaches.

Studietype

Ingrijpend

Inschrijving (Verwacht)

20

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
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Werving
        • Kingston Health Sciences Centre
        • Contact:

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

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  • Participants will be eligible for enrollment if they have both of:

    1. Lesion in the prostate on mpMRI that is highly likely to be clinically significant prostate cancer based on the PI-RADS version 2 score (PI-RADS score of 4 or 5).
    2. A previous negative TRUSP biopsy or previous TRUSP biopsy showing atypical small acinar proliferation, high grade prostatic intraepithelial neoplasia or low volume Gleason 6 disease (low risk disease) all of which are incongruent with the high PI-RADS score of the mpMRI lesion.

Exclusion Criteria:

  1. Uncorrected coagulopathy.
  2. Active, untreated urinary tract infection.
  3. Inability to access the rectum in order to perform TRUSP biopsy.

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: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: CT Fusion Biopsy + Transrectal U/S Guided Prostate Biopsy
All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.
Procedure: CT Fusion + Transrectal U/S Guided Prostate Biopsy
All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.
Ander: Transrectal U/S Guided Prostate Biopsy + CT Fusion Biopsy
All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.
Procedure: CT Fusion + Transrectal U/S Guided Prostate Biopsy
All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Accuracy of CT fusion biopsy [number of biopsies that show clinically significant prostate cancer]
Tijdsspanne: Day 0
Patients will be considered to have clinically significant prostate cancer based on their PI-RADS score 4 or 5. The ability of TRUSP biopsy and cone beam CT guided biopsy to detect any form of prostate cancer as well as clinically significant prostate cancer (defined as prostate cancer with a Gleason score ≥7) will serve as the primary outcome measures.
Day 0

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Tijdsspanne: 0 Day and at 30 day
Immediate procedure related complications will be documented at the time of procedures. The 30 day return to the ER and hospital admission rates will be documented at the participant's following appointment.
0 Day and at 30 day
Tolerability of CT fusion biopsy
Tijdsspanne: Day 0
Patients will fill out the 0-10 point Universal Pain Assessment Tool after each procedure where 0 is no pain and 10 is the worst pain possible. After both procedures are completed, patients will also fill out two questions utilizing a 1-7 point Likert scale on preference and comfort between the two biopsy approaches where 1 represents rectum biopsy and 7 represents buttock muscle biopsy.
Day 0

Medewerkers en onderzoekers

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

Sponsor

Queen's University

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 (Werkelijk)

6 november 2019

Primaire voltooiing (Verwacht)

1 juli 2020

Studie voltooiing (Verwacht)

1 augustus 2020

Studieregistratiedata

Eerst ingediend

20 november 2019

Eerst ingediend dat voldeed aan de QC-criteria

25 november 2019

Eerst geplaatst (Werkelijk)

27 november 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 december 2019

Laatste update ingediend die voldeed aan QC-criteria

2 december 2019

Laatst geverifieerd

1 december 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 6018147

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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