Prostate CancerNCT01347320
Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer
A study testing Preoperative MRI in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The investigators want to evaluate if preoperative MRI improves the surgical results, especially in respect to surgical margins. The impact on the surgical procedure will be evaluated. In addition the investigators will examine the accuracy of tumor detection, localization and staging. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Preoperative MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to Jul 2012
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients suitable for surgery.
- Positive biopsy (Gleason grade >3).
- Informed consent.
Who cannot join
- Patients who do not sign the consent paper for any reason or do not accept the study premises.
- Patents who want to withdraw for any reason during the study.
- Patients with contraindications to MRI (pacemaker, claustrophobia etc) and/or surgery.
- Patients who have undergone a high quality MRI examination of the prostate at another radiological center. In this situation the MR examination is evaluated together with the surgeon but the patient is not included in the study. (In case of a low quality examinations, we will disregard the findings, and include the patient).
- If the surgeon finds it unacceptable to perform RALP without MRI, because of various reasons (eg. patient demand, too high risk etc) the patient will not be included in the study.
- If preoperative MRI reveals extensive tumor invasion into adjacent organ (T4) or skeletal metastases (M1), as these cancer stadiums do not benefit from RALP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Impact of MR Imaging in Patients With Prostate Cancer
The investigators want to evaluate if preoperative MRI improves the surgical results, especially in respect to surgical margins. The impact on the surgical procedure will be evaluated.
In addition the investigators will examine the accuracy of tumor detection, localization and staging.
Read the detailed description
Background:
During the last two decades, Magnetic Resonance Imaging (MRI) of the prostate has evolved to become a promising tool in preoperative evaluation of prostate cancer. Several studies have evaluated the radiological and histopathological correlation. However, the sensitivity and specificity in regard to staging have shown wide ranges and poor reproducibility. These discrepancies can be explained by difference in patient selection, MRI methods, and criteria used for diagnosis. More studies are therefore needed to evaluate the clinical impact of preoperative MRI in patients with prostate cancer.
Aims of the study:
To evaluate 1) detection rate of tumor 1-3 (tumor 1 = index tumor), size of tumor 1-3, possible extraprostatic extension and predict presence of Gleason grade 4 and 5 tumor, 2) the influence of preoperative MRI on the surgical decision process with respect to the operative procedure for removal of the gland and pelvic lymph node dissection, and 3) the impact of preoperative MRI on the rate of positive surgical margins and functional results.
Material and method:
A prospective study including 400 consecutive patients referred to robot assisted laparoscopic prostatectomy randomised to preoperative MRI (intervention group) and no MRI (control group). The prostatectomy specimens will be histopathologically examined, and TNM classification will be performed according to 2002 AJCC standard.
- Conditions
- Prostate Cancer
- Being tested
- Preoperative MRI
- Keywords
- Prostate cancer, preoperative staging, MRI, Free surgical margins
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative MRIOther
Preoperative staging
| Study group | Role | What they receive |
|---|---|---|
| No preoperative MRI | No intervention | control arm of the study |
| MRI group | Active comparator | preoperative MRI Receives: Other: Preoperative MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical margins
The surgical margins are assessed by evaluating the pathological specimen
Measured: 30 days
Secondary outcomes (4)
Surgical decision process
Evaluated using questionaire
Measured: 30 days
Preoperative TNM classification
Based upon preoperative MRI
Measured: 1-4 weeks
Detection of Gleason grade 4 and 5
Measured: 30 days
Functional outcome
Evaluate the functional outcome in respect to erectile dysfunction.
Measured: 1 year after prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startNov 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Rud, Oslo University Hospital
- Investigators
- Erik Rud, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347320
- Sponsor's protocol ID
- OsloUH
- Status last verified
- Dec 2013
- First submitted
- 9 Mar 2010
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rud E, Baco E, Klotz D, Rennesund K, Svindland A, Berge V, Lundeby E, Wessel N, Hoff JR, Berg RE, Diep L, Eggesbo HB, Eri LM. Does preoperative magnetic resonance imaging reduce the rate of positive surgical margins at radical prostatectomy in a randomised clinical trial? Eur Urol. 2015 Sep;68(3):487-96. doi: 10.1016/j.eururo.2015.02.039. Epub 2015 Mar 23.
PubMed 25813692Rud E, Klotz D, Rennesund K, Baco E, Johansen TE, Diep LM, Svindland A, Eri LM, Eggesbo HB. Preoperative magnetic resonance imaging for detecting uni- and bilateral extraprostatic disease in patients with prostate cancer. World J Urol. 2015 Jul;33(7):1015-21. doi: 10.1007/s00345-014-1362-x. Epub 2014 Jul 25.
PubMed 25059766
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of MR Imaging in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01347320
- Acronym / sponsor ID
- OsloUH
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, preoperative staging, MRI, Free surgical margins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 May 2011 (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 investigators want to evaluate if preoperative MRI improves the surgical results, especially in respect to surgical margins. The impact on the surgical procedure will be evaluated.
In addition the investigators will examine the accuracy of tumor detection, localization and staging.
Detailed description
Background:
During the last two decades, Magnetic Resonance Imaging (MRI) of the prostate has evolved to become a promising tool in preoperative evaluation of prostate cancer. Several studies have evaluated the radiological and histopathological correlation. However, the sensitivity and specificity in regard to staging have shown wide ranges and poor reproducibility. These discrepancies can be explained by difference in patient selection, MRI methods, and criteria used for diagnosis. More studies are therefore needed to evaluate the clinical impact of preoperative MRI in patients with prostate cancer.
Aims of the study:
To evaluate 1) detection rate of tumor 1-3 (tumor 1 = index tumor), size of tumor 1-3, possible extraprostatic extension and predict presence of Gleason grade 4 and 5 tumor, 2) the influence of preoperative MRI on the surgical decision process with respect to the operative procedure for removal of the gland and pelvic lymph node dissection, and 3) the impact of preoperative MRI on the rate of positive surgical margins and functional results.
Material and method:
A prospective study including 400 consecutive patients referred to robot assisted laparoscopic prostatectomy randomised to preoperative MRI (intervention group) and no MRI (control group). The prostatectomy specimens will be histopathologically examined, and TNM classification will be performed according to 2002 AJCC standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No preoperative MRI | No intervention | –control arm of the study |
| MRI group | Active comparator | Other: Preoperative MRIpreoperative MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients suitable for surgery.
- Positive biopsy (Gleason grade >3).
- Informed consent.
Key exclusion criteria (6 listed)
- Patients who do not sign the consent paper for any reason or do not accept the study premises.
- Patents who want to withdraw for any reason during the study.
- Patients with contraindications to MRI (pacemaker, claustrophobia etc) and/or surgery.
- Patients who have undergone a high quality MRI examination of the prostate at another radiological center. In this situation the MR examination is evaluated together with the surgeon but the patient is not included in the study. (In case of a low quality examinations, we will disregard the findings, and include the patient).
- If the surgeon finds it unacceptable to perform RALP without MRI, because of various reasons (eg. patient demand, too high risk etc) the patient will not be included in the study.
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 |
|---|---|---|
| Preoperative MRIPreoperative staging | Other | MRI group |
Primary outcome
Surgical margins
Time frame: 30 days
The surgical margins are assessed by evaluating the pathological specimen
4 secondary outcomes
Surgical decision process
Time frame: 30 days
Preoperative TNM classification
Time frame: 1-4 weeks
Detection of Gleason grade 4 and 5
Time frame: 30 days
Functional outcome
Time frame: 1 year after prostatectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Derived from this study: PubMed 25813692Rud E, Baco E, Klotz D, Rennesund K, Svindland A, Berge V, Lundeby E, Wessel N, Hoff JR, Berg RE, Diep L, Eggesbo HB, Eri LM. Does preoperative magnetic resonance imaging reduce the rate of positive surgical margins at radical prostatectomy in a randomised clinical trial? Eur Urol. 2015 Sep;68(3):487-96. doi: 10.1016/j.eururo.2015.02.039. Epub 2015 Mar 23.
- Derived from this study: PubMed 25059766Rud E, Klotz D, Rennesund K, Baco E, Johansen TE, Diep LM, Svindland A, Eri LM, Eggesbo HB. Preoperative magnetic resonance imaging for detecting uni- and bilateral extraprostatic disease in patients with prostate cancer. World J Urol. 2015 Jul;33(7):1015-21. doi: 10.1007/s00345-014-1362-x. Epub 2014 Jul 25.
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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.
Erik Rud, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative MRI in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 30 Dec 2013. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical margins (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01347320, which also lists 2 linked publications.
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 30 Dec 2013.