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Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers (IMPROD2_0)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Prostate MRI
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Magnetic Resonance Imaging

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 40 to 85 years
  • Language spoken: Finnish
  • Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

  • previous prostate biopsies
  • previous diagnosis of prostate carcinoma
  • previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
  • symptomatic of acute prostatitis
  • contraindications for MRI (cardiac pacemaker, intracranial clips etc)
  • uncontrolled serious infection
  • claustrophobia
  • any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist

Sites / Locations

  • Department of Urology, Turku University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRI and biomarkers

Arm Description

Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy.

Outcomes

Primary Outcome Measures

Sensitivity, specificity and accuracy of MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy

Secondary Outcome Measures

Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer
Serum and urine samples before prostate biopsy and tissue samples during prostatectomy

Full Information

First Posted
July 22, 2016
Last Updated
July 25, 2016
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02844829
Brief Title
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
Acronym
IMPROD2_0
Official Title
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml or abnormal digital rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.
Detailed Description
Specific aims of the current study are as follows: i) To determine the sensitivity, specificity and accuracy of a novel rapid anatomical MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy ii) To determine the sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer iii) To develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid MRI/DWI and selected biomarkers iv) To assess the applicability of TRUS guided prostate biopsy based on MRI finding in patient with no previous prostate biopsy v) To develop and validate an imaging protocol which will become the standard protocol for prostate imaging at Medical Imaging Centre of Southwest Finland (VSKK) / TYKS, Turku, Finland.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI and biomarkers
Arm Type
Other
Arm Description
Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy.
Intervention Type
Other
Intervention Name(s)
Prostate MRI
Intervention Description
MRI of the prostate prior to prostate biobsy
Primary Outcome Measure Information:
Title
Sensitivity, specificity and accuracy of MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy
Time Frame
Baseline (MRI prior to prostate biopsy)
Secondary Outcome Measure Information:
Title
Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer
Description
Serum and urine samples before prostate biopsy and tissue samples during prostatectomy
Time Frame
Baseline and during procedure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 40 to 85 years Language spoken: Finnish Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination Mental status: Patients must be able to understand the meaning of the study Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff Exclusion Criteria: previous prostate biopsies previous diagnosis of prostate carcinoma previous prostate surgeries, e.g. TURP (transurethral prostatic resection) symptomatic of acute prostatitis contraindications for MRI (cardiac pacemaker, intracranial clips etc) uncontrolled serious infection claustrophobia any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannu J Aronen, M.D. Ph.D.
Phone
+358 2 3133896
Email
hannu.aronen@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu J Aronen, M.D. Ph.D.
Organizational Affiliation
Diagnostic radiology University of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Turku University Hospital
City
Turku
State/Province
Western Finland Province
ZIP/Postal Code
FI-20520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter J Boström, M.D., Ph.D
Phone
+358 2 3130243
Email
peter.boström@tyks.fi

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers

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