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

Prostate Cancer Clinical Trial

— PROAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02545881
• Other study ID #: Turku UH
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2015
• Last updated: October 18, 2016
• Start date: July 2015

Study information

• Verified date: October 2016
• Source: Turku University Hospital
• Contact: Hannu Aronen, M.D., Ph.D.
• Phone: +358 2 3133896
• Email: hannu.aronen[@]utu.fi
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aggression
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Magnetic Resonance Imaging (MRI)
MRI of the prostate prior to prostatectomy

Locations

Country	Name	City	State
Finland	Department of Urology, Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No