MRI and Biomarkers in Prostate Cancer

Prostate Cancer Clinical Trial

— Multi-IMPROD  

Official title:

Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241122
• Other study ID #: 72/1801/2014
• Status: Completed
• Phase: N/A
• First received: September 12, 2014
• Last updated: April 16, 2018
• Start date: April 2015
• Est. completion date: April 1, 2018

Study information

• Verified date: April 2018
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prostate cancer has been the most common neoplastic disease in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.

This prospective multi-institutional study will enroll 400 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 1.5/3 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 1, 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age: 18 to 85 years

• Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 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 within 6 months

• 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

• hip replacement surgery or other metal implants in the pelvic area

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• prostate biopsy

Locations

Country	Name	City	State
Finland	Department of Urology, Helsinki University Hospital	Helsinki
Finland	Department of Urology, Kuopio University Hospital	Kuopio
Finland	Department of Urology, Pori Central Hospital	Pori
Finland	Department of Urology, Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Jambor I, Kähkönen E, Taimen P, Merisaari H, Saunavaara J, Alanen K, Obsitnik B, Minn H, Lehotska V, Aronen HJ. Prebiopsy multiparametric 3T prostate MRI in patients with elevated PSA, normal digital rectal examination, and no previous biopsy. J Magn Reson Imaging. 2015 May;41(5):1394-404. doi: 10.1002/jmri.24682. Epub 2014 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of bacterial strains	The bacterial resistance towards antibiotics is evaluated.	18 months
Primary	Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis	Biparametric MRI (T2wi+DWI) is performed in patients with a clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies.	18 months
Secondary	Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis	Accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis will be evaluated.; Gene expression profile of selected genes will be compared between cancer and non-cancer cases to investage optimal gene expression panels for prostate cancer risk prediction. Similarly serum and urine marker profiles are compared between cancer and non-cancer cases	18 months