Improved Prostate Cancer Diagnosis - Combination of Rapid... | NCT02844829

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

NCT02844829

Sponsor

Turku University Hospital

Status

Unknown status

Last Update Posted

Jul 26, 2016Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Prostate MRI

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 22, 2016

First Submission Date that Met QC Criteria

Jul 25, 2016

First Posted Date

Jul 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI and biomarkers	Other	Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy.	Other: Prostate MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prostate MRI	Other	MRI of the prostate prior to prostate biobsy	MRI and biomarkers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		Baseline (MRI prior to prostate biopsy)

Secondary Outcomes

Measure	Description	Time Frame
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	Baseline and during procedure

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hannu J Aronen, M.D. Ph.D.	Contact	+358 2 3133896		hannu.aronen@utu.fi

Overall Officials

Name	Affiliation	Role
Hannu J Aronen, M.D. Ph.D.	Diagnostic radiology University of Turku	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Turku University Hospital	Recruiting	Turku	Western Finland Province	FI-20520	Finland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided