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MR-targeted vs. Random TRUS-guided Prostate Biopsy (Pro-Cure2014)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MR-guided in-bore prostate biopsy
TRUS-guided prostate biopsy
Sponsored by
Fondazione del Piemonte per l'Oncologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring multiparametric magnetic resonance imaging, MR-targeted prostate biopsy, saturation TRUS-guided prostate biopsy

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • men aged 50-80
  • at least one negative TRUS-guided prostate biopsy
  • PSA > 4 ng/ml
  • at least one suspected region detected at multiparametric MR imaging
  • signed informed consent

Exclusion Criteria:

  • known prostate cancer diagnosis
  • contraindication against MR imaging or uncooperative patients

Sites / Locations

  • Fondazione del Piemonte per l'Oncologia - Candiolo Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MR-targeted biopsy

TRUS-guided biopsy

Arm Description

Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MR imaging two targeted biopsy cores will be taken.

Patients of arm B receive a saturation TRUS-guided prostate biopsy.

Outcomes

Primary Outcome Measures

Prostate cancer detection rate

Secondary Outcome Measures

Full Information

First Posted
February 5, 2016
Last Updated
August 19, 2016
Sponsor
Fondazione del Piemonte per l'Oncologia
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1. Study Identification

Unique Protocol Identification Number
NCT02678481
Brief Title
MR-targeted vs. Random TRUS-guided Prostate Biopsy
Acronym
Pro-Cure2014
Official Title
MR-targeted vs. Random TRUS-guided Prostate Biopsy in Patients With High PSA Values and Previous Negative Biopsy Results: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione del Piemonte per l'Oncologia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least one previous negative prostate biopsy. Subjects will be submitted to a multiparametric MR scan of the prostate and subsequently patients with a suspicious MR for PCa presence will be randomized (1:1) into the two study arms.
Detailed Description
In men with previously negative prostate biopsy and persistent elevated PSA value, it is unclear which biopsy strategy offers the highest detection rate for significant PCa. The hypothesis of this study is that MR-targeted biopsy improves the detection rates of significant prostate cancers compared with systematic TRUS-guided prostate biopsy. Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA values (> 4 ng/ml) will be submitted to a multiparametric MR imaging examination of the prostate. Subsequently, participants with suspected regions at MR imaging will be randomized (1:1) into the two study arms. In study arm A patients will be submitted to MR-targeted in-bore prostate biopsy based on the multiparametric MR imaging findings. In study arm B patients will be submitted to systematic TRUS-guided prostate biopsy with saturation scheme.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
multiparametric magnetic resonance imaging, MR-targeted prostate biopsy, saturation TRUS-guided prostate biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MR-targeted biopsy
Arm Type
Experimental
Arm Description
Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MR imaging two targeted biopsy cores will be taken.
Arm Title
TRUS-guided biopsy
Arm Type
Experimental
Arm Description
Patients of arm B receive a saturation TRUS-guided prostate biopsy.
Intervention Type
Device
Intervention Name(s)
MR-guided in-bore prostate biopsy
Intervention Description
2 targeted biopsy cores from each prostate lesion detected at multiparametric MR imaging
Intervention Type
Device
Intervention Name(s)
TRUS-guided prostate biopsy
Intervention Description
24-28 systematic biopsy core (saturation scheme)
Primary Outcome Measure Information:
Title
Prostate cancer detection rate
Time Frame
within the 3 months after MR imaging

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: men aged 50-80 at least one negative TRUS-guided prostate biopsy PSA > 4 ng/ml at least one suspected region detected at multiparametric MR imaging signed informed consent Exclusion Criteria: known prostate cancer diagnosis contraindication against MR imaging or uncooperative patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniele Regge, MD
Phone
+39 011 9933 367
Email
daniele.regge@ircc.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele Regge, MD
Organizational Affiliation
Fondazione del Piemonte per l'Oncologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute
City
Candiolo
State/Province
Turin
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo Russo, MD
Phone
+39 011 9933 367
Email
filippo.russo@ircc.it

12. IPD Sharing Statement

Plan to Share IPD
No

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MR-targeted vs. Random TRUS-guided Prostate Biopsy

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