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

NCT ID: NCT02545881

Last Updated: 2016-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Magnetic Resonance Imaging (MRI)

MRI of the prostate prior to prostatectomy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hannu Aronen

Professor, Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Urology, Turku University Hospital

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Hannu Aronen, M.D., Ph.D.

Role: CONTACT

+358 2 3133896

Facility Contacts

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Peter Boström, M.D., Ph.D.

Role: primary

+358 2 3130243

Other Identifiers

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Turku UH

Identifier Type: -

Identifier Source: org_study_id

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