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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02545881
Acronym
PROAG
Enrollment
200
Registered
2015-09-10
Start date
2015-07-31
Completion date
Unknown
Last updated
2016-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

OTHERMagnetic Resonance Imaging (MRI)

MRI of the prostate prior to prostatectomy

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
30 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MR relaxation valuesWithin 1 month prior to prostatectomyAim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer
MR DWI parametersWithin 1 month prior to prostatectomyAim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer
Histological prostate cancer aggressiveness (Gleason grade)Within 1 month after MR imaging of the prostateAim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer

Countries

Finland

Contacts

Primary ContactHannu Aronen, M.D., Ph.D.
hannu.aronen@utu.fi+358 2 3133896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026