Evaluation of Modern MRI in the Diagnosis of Prostate Cancer in a Danish Setup

NCT01640262 | Completed

• 1 other identifier: H-1-2011-066
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical staging of prostate cancer in Denmark is determined solely by digital rectal examination and sometimes by TRUS, even though the investigators know these examinations are inaccurate and have limitations. Since the majority of men diagnosed with prostate cancer will die with their disease and not of their disease, and the different treatment-options may imply greater side effects, it is important to improve the diagnostic localization and staging of the tumour for optimal clinical management and therapy selection. The development of modern multiparametric-high-field-magnetic-imaging (mMRI) offers new possibilities and approaches in detection, localization and staging of prostate cancer due to its high resolution and soft-tissue contrast. mMRI can provide information about the morphological, metabolic and cellular changes and characterize tissue- and tumour- vascularity and correlate it with tumour aggressiveness. This helps to locate and stage a possible tumour and to guide targeted-biopsies towards disease-suspicious areas. Internationally published data support the rapidly growing use of multiparametric MRI, as being the most sensitive and specific imaging tool for prostate cancer patients. While mMRI internationally is a well recognized and accepted method for detection, localization and staging of prostate cancer, the use of mMRI in the diagnosis of PCa in Denmark has never been applied. Therefore, this project is carried out in order to evaluate the use of modern mMRI in the diagnosis of prostate cancer in a Danish setup.

Conditions

Prostatic Neoplasms

Keywords

prostate biopsy; prostate cancer; Magnetic Resonance Imaging; Neoplasm Staging

Outcome Measures

Primary Outcomes (1)

• Change in the diagnosis and treatment planning based on MRI examination

  Study 1: Change in clinical T-stage (TNM-classification) at baseline compared to the patological T-stage after curative treatment approx. 4 weeks later. Study 2: Change in prostatic volumen expressed in milliliter(ml) on CT and MRI 4 weeks after brachytherapy-operation compared to the prostatic volumen on TRUS at baseline. Study 3: Change detectionrate of prostatecancer using MRI-targeted biopsies.

  The participants will be followed for the duration of the hospital diagnostic investagation, an expected average of 4 weeks

Secondary Outcomes (1)

• To gain experience in the use of modern multiparametric MRI in Denmark to evaluate prostatic tumors.

  2 years

Study Arms (1)

localized prostate cancer

Danish men with localized prostate cancer

Other: Multiparametric magnetic resonance imaging (mMRI)

Interventions

Multiparametric magnetic resonance imaging (mMRI) OTHER

A mMRI is performed before treatment of the patient and is compared to the standard diagnostic tools for evaluating the clinical stage and diagnose of prostate cancer

localized prostate cancer

Eligibility Criteria

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

Study Population

* Study 1 is offered to 140 patients with newly diagnosed localized prostate cancer and is comparing mMRI to TRUS and DRE in the assessment of the clinical stage of prostate cancer. * Study 2 is offered to 55 patients with newly diagnosed localized prostate cancer who have undergone Brachytherapy and is comparing MRI to CT scan performed 4 weeks after surgery in the evaluation of postoperative dosimetry (treatment effect). * Study 3 is offered to 55 patients scheduled for re-biopsy due to continuing suspicion of prostate cancer after standard TRUS-guided biopsies with negative findings. Standardised TRUS-guided re-biopsies as well as TRUS biopsies of any MRI-suspicious lesion are performed in the same session and marked separately. The MRI-targeted biopsies are compared to the standard TRUS-guided re-biopsies to see if multiparametric MRI can detect prostate cancer invisible on transrectal ultrasound; in order to improve detection rate.

You may qualify if:

• Patients with newly diagnosed localized (T1-2) or locally advanced (T3)prostate cancer

You may not qualify if:

• Metastatic prostate cancer
• Prostate cancer treatment
• Known allergic reaction to Gadolinium-based MRI contrast agent
• Prostate biopsy during the last 21 days
• Impaired renal function with GFR \< 30 ml / min
• pacemaker
• Magnetic metal residues in the body
• Claustrophobia
• Psychiatric disorders
• Age under 18 years
• \- Patients with localized prostate cancer who underwent brachytherapy 4 weeks prior to MRI.
• Metastatic prostate cancer
• Prostate cancer treatment other than Brachytherapy
• Known allergic reaction to Gadolinium-based MRI contrast agent
• Prostate biopsy during the last 21 days

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Department of Urology, Herlev University Hospital

Herlev, Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lars P. Boesen, M.D.

  Department of Urology and Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 13, 2012
• Study Start: August 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 3, 2016

Record last verified: 2014-05

Locations

DK (1)