Prostatic NeoplasmsPhase 1/2NCT00230386
Role of Magnetic Resonance Imaging (MRI) Perfusion to Detect Disease in Prostate Carcinoma
A Phase 1/2 study testing MRI in people with Prostatic Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a pilot study of 50 patients to establish whether there is a potential role for MRI perfusion in the detection of locally recurrent or persistent prostate carcinoma after previous treatment with radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2003to not given
- Phase
- Phase 1/2
- 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
- Previously have had radical radiotherapy for localised prostate cancer
- Due to undergo routine post-treatment prostatic biopsies
- Suitable for MRI scan
- Adequate renal function
- No previous reaction to gadolinium
- Able to give informed consent
- No recent prostate biopsy within 6 weeks of enrolment
- Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 or 1
Who cannot join
- Not suitable for MRI scan
- Previous reaction to gadolinium
- Impaired renal function
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: The Role of MRI Perfusion to Detect Locally Recurrent or Persistent Disease in Prostate Carcinoma Treated With Radiation Therapy - A Pilot Study
This is a pilot study of 50 patients to establish whether there is a potential role for MRI perfusion in the detection of locally recurrent or persistent prostate carcinoma after previous treatment with radiotherapy. All subjects will be patients who have had localised prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the prostate to look at local control within the prostate as part of their management. The objective of the study is to establish whether there is a relationship between recurrent or persistent disease within the prostate and increased perfusion on MRI at these sites.
- Conditions
- Prostatic Neoplasms
- Being tested
- 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.
MRIDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether there may be a role for MRI perfusion in the detection of recurrent or persistent prostatic cancer after previous radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Investigators
- Michael Milosevic, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230386
- Sponsor's protocol ID
- UHN REB 03-0272-CE
- Status last verified
- Sep 2005
- First submitted
- 28 Sep 2005
- Last updated
- 14 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of MRI Perfusion to Detect Locally Recurrent or Persistent Disease in Prostate Carcinoma Treated With Radiation Therapy - A Pilot Study
- ClinicalTrials.gov ID
- NCT00230386
- Acronym / sponsor ID
- UHN REB 03-0272-CE
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- May 2003
- First posted
- 30 Sep 2005 (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.
This is a pilot study of 50 patients to establish whether there is a potential role for MRI perfusion in the detection of locally recurrent or persistent prostate carcinoma after previous treatment with radiotherapy. All subjects will be patients who have had localised prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the prostate to look at local control within the prostate as part of their management. The objective of the study is to establish whether there is a relationship between recurrent or persistent disease within the prostate and increased perfusion on MRI at these sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Previously have had radical radiotherapy for localised prostate cancer
- Due to undergo routine post-treatment prostatic biopsies
- Suitable for MRI scan
- Adequate renal function
- No previous reaction to gadolinium
Key exclusion criteria (4 listed)
- Not suitable for MRI scan
- Previous reaction to gadolinium
- Impaired renal function
- Inability to give informed consent
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 |
|---|---|---|
| MRI | Device | – |
Primary outcome
To determine whether there may be a role for MRI perfusion in the detection of recurrent or persistent prostatic cancer after previous radiotherapy
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 14 Jul 2009.
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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.
Michael Milosevic, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MRI in people with Prostatic Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
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 8 inclusion and 4 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 14 Jul 2009. 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 Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine whether there may be a role for MRI perfusion in the detection of recurrent or persistent prostatic cancer after previous radiotherapy. 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 14 Jul 2009.