Development and Validation of Novel MRI Methods for the D... | NCT02545881

Studies
Development and Validation of Novel MRI Methods for the Detection of Prostate Cancer Aggressiveness

NCT02545881

Sponsor

Turku University Hospital

Status

Unknown status

Last Update Posted

Oct 19, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Magnetic Resonance Imaging (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

Oct 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 2015

Primary Completion Date

Dec 2018Estimated

Completion Date

Not provided

First Submitted Date

Aug 5, 2015

First Submission Date that Met QC Criteria

Sep 7, 2015

First Posted Date

Sep 10, 2015Estimated

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

Oct 18, 2016

Last Update Posted Date

Oct 19, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to develop, validate, and evaluate the correlation of novel magnetic resonance imaging (MRI) methods with prostate cancer aggressiveness and histological data obtained during prostatectomy.

Detailed Description

Prostate cancer is one of the most common neoplastic diseases in men. Prostate specific antigen (PSA) has only a limited role in the diagnosis and characterization of prostate cancer. The diagnosis of prostate cancer is still most commonly done by transrectal ultrasonography (TRUS) guided biopsy. However, TRUS guided biopsy carries a risk of increase in complications. There is an increasing interest in developing more accurate non-invasive imaging modalities which could potentially detect prostate cancer aggressiveness.

Diffusion weighted imaging (DWI) and rotating frame relaxation measurements have shown to be particularly promising in prostate cancer detection and characterization. This study which focuses on further development and validation of DWI and rotating frame relaxation measurements will enroll 200 men with histologically diagnosed prostate cancer who will undergo magnetic resonance imaging (MRI) before prostatectomy. Anatomical MRI and novel acquisition methods focusing on DWI and rotating frame relaxation measurements will be performed using surface coils to non-invasively detect and characterize prostate cancer.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging (MRI)	Other	MRI of the prostate prior to prostatectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MR relaxation values	Aim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer	Within 1 month prior to prostatectomy
MR DWI parameters	Aim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer	Within 1 month prior to prostatectomy
Histological prostate cancer aggressiveness (Gleason grade)	Aim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer	Within 1 month after MR imaging of the prostate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 35 to 85 years
Language spoken: Finnish
Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
Diagnosis: Histologically confirmed adenocarcinoma of prostate
No previous surgical, radiation or endocrine treatment for prostate carcinoma
Clinical stage T1c-T3aN0 based on transrectal ultrasound, pelvic CT and bone scintigraphy
Time period between the last biopsy and scheduled radical prostatectomy less than 8 months
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 surgeries, e.g. TURP (transurethral prostatic resection)
symptomatic acute prostatitis
contraindications for MRI (cardiac pacemaker, intracranial clips etc)
uncontrolled serious infection
claustrophobia

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with histologically diagnosed prostate cancer who are scheduled for radical prostatectomy in a university hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

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

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

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided