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

NCT02545881 | Unknown

• 1 other identifier: Turku UH
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Magnetic Resonance Imaging (MRI) OTHER

MRI of the prostate prior to prostatectomy

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
• symptomatic acute prostatitis
• contraindications for MRI (cardiac pacemaker, intracranial clips etc)
• uncontrolled serious infection
• claustrophobia

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Department of Urology, Turku University Hospital

Turku, FI-20520, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed tissue

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

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

CONTACT

+358 2 3133896; hannu.aronen@utu.fi

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: September 10, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2018
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

FI (1)