Clinical trial NCT02545881: Development and Validation of Novel MRI Methods for the Detection of Prostate Cancer Aggressiveness
Official title: Development and Validation of Novel MRI Methods for the Detection of Prostate Cancer Aggressiveness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2015-09-10
Enrollment: 200
Sex: MALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histologically diagnosed prostate cancer who are scheduled for radical prostatectomy in a university hospital

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: MR relaxation values
timeFrame: Within 1 month prior to prostatectomy
measure: MR DWI parameters
timeFrame: Within 1 month prior to prostatectomy
measure: Histological prostate cancer aggressiveness (Gleason grade)
timeFrame: Within 1 month after MR imaging of the prostate
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Urology, Turku University Hospital
Study officials:
References: