Prostate CancerPROAGNCT02545881
Development and Validation of Novel MRI Methods for the Detection of Prostate Cancer Aggressiveness
An observational study of Prostate Cancer, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Jul 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically diagnosed prostate cancer who are scheduled for radical prostatectomy in a university hospital
Who may be able to join
- 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
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- 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
Who cannot join
- previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
- symptomatic acute prostatitis
- contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- uncontrolled serious infection
- claustrophobia
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Department of Urology, Turku University Hospital
Turku, FI-20520
Peter Boström, M.D., Ph.D., +358 2 3130243, peter.bostrom@tyks.fi
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
MRI of the prostate prior to prostatectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 1 month prior to prostatectomy
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
Measured: Within 1 month prior to prostatectomy
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
Measured: Within 1 month after MR imaging of the prostate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hannu Aronen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545881
- Sponsor's protocol ID
- Turku UH
- Acronym
- PROAG
- Status last verified
- Oct 2016
- First submitted
- 5 Aug 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Novel MRI Methods for the Detection of Prostate Cancer Aggressiveness
- ClinicalTrials.gov ID
- NCT02545881
- Acronym / sponsor ID
- PROAG / Turku UH
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Jul 2015
- Primary completion
- Dec 2018 (estimated)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically diagnosed prostate cancer who are scheduled for radical prostatectomy in a university hospital
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
- symptomatic acute prostatitis
- contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- uncontrolled serious infection
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)MRI of the prostate prior to prostatectomy | Other | – |
Primary outcome
MR relaxation values
Time frame: Within 1 month prior to prostatectomy
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
MR DWI parameters
Time frame: Within 1 month prior to prostatectomy
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
Histological prostate cancer aggressiveness (Gleason grade)
Time frame: Within 1 month after MR imaging of the prostate
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannu Aronen, M.D., Ph.D. (+358 2 3133896, hannu.aronen@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR relaxation values (time frame: Within 1 month prior to prostatectomy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.