Prostate CancerNCT01006564
Multifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer
A study testing Imaging Investigations (not radiation) and Other in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To determine if functional MRI methods will aid planning of a radiation dose boost within the prostate in patients with prostate cancer potentially improving safety and efficacy. Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Imaging Investigations (not radiation) and Other
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to Jun 2011
- 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 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hormone therapy naive patients planned to be treated by radical radiotherapy after 3-6 months of androgen suppression
- Patients with low-high risk histologically confirmed localised disease are eligible, with WHO performance status 0-1.
Who cannot join
- Patients unsuitable for functional MRI of the prostate or gold seed fiducial marker insertion (e.g. patients unable to tolerate endorectal MRI examination).
- No prior pelvic radiotherapy or radical prostatectomy, previous androgen therapy, patients unsuitable for radical radiotherapy, life expectancy <10 years, previous active malignancy within last 5 years, co-morbid conditions likely to impact on the advisability of radical radiotherapy, full anticoagulation, other exclusions to MRI (e.g. hip prosthesis or fixation, claustrophobia, ferromagnetic implants).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Multifunctional MR for Radiotherapy Planning in Prostate Cancer
To determine if functional MRI methods will aid planning of a radiation dose boost within the prostate in patients with prostate cancer potentially improving safety and efficacy.
- Conditions
- Prostate Cancer
- Being tested
- Imaging Investigations (not radiation), Other
- Keywords
- Magnetic Resonance Imaging, Prostate Cancer, Magnetic Resonance Spectroscopy, Radiotherapy planning
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging Investigations (not radiation)Other
Pre-hormone therapy MRI scans will be performed as an adjunct to the patients' staging MRI scan; post hormone MRI will be done wholly for research purposes.
OtherOther
Insertion of gold seeds into prostate for image registration.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of dose distributions produced by rival radiotherapy plans judged using radiobiological model predictions of Tumour Control Probability (TCP) and Normal Tissue Complication Probability (NTCP).
Secondary outcomes (4)
Comparison of reproducibility of registration algorithms for mapping functional MR data acquired before hormone therapy to MR anatomical data acquired after hormone therapy and prior to radiotherapy.
Comparison of reproducibility of registration of functional and MR data with computed tomography (CT) data using gold seed registration, assessing reproducibility and positioning issues.
Comparison of image quality, registration reproducibility and gland distortion of internal and external imaging coils for MRI image acquisition and registration of the prostate.
Comparison of dose distributions produced by rival radiotherapy plans judged using three standard dose-volume constraints for targets and normal tissues and careful examination of the 3D dose distribution.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (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.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Investigators
- Dr Nandita deSouza, Principal investigator, CRUK Clinical Magnetic Resonance Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006564
- Sponsor's protocol ID
- CCR3121
- Status last verified
- Nov 2009
- First submitted
- 2 Nov 2009
- Last updated
- 3 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifunctional MR for Radiotherapy Planning in Prostate Cancer
- ClinicalTrials.gov ID
- NCT01006564
- Acronym / sponsor ID
- CCR3121
- Conditions
- Prostate Cancer
- Keywords
- Magnetic Resonance Imaging, Prostate Cancer, Magnetic Resonance Spectroscopy, Radiotherapy planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 3 Nov 2009 (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.
To determine if functional MRI methods will aid planning of a radiation dose boost within the prostate in patients with prostate cancer potentially improving safety and efficacy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hormone therapy naive patients planned to be treated by radical radiotherapy after 3-6 months of androgen suppression
- Patients with low-high risk histologically confirmed localised disease are eligible, with WHO performance status 0-1.
Key exclusion criteria (2 listed)
- Patients unsuitable for functional MRI of the prostate or gold seed fiducial marker insertion (e.g. patients unable to tolerate endorectal MRI examination).
- No prior pelvic radiotherapy or radical prostatectomy, previous androgen therapy, patients unsuitable for radical radiotherapy, life expectancy <10 years, previous active malignancy within last 5 years, co-morbid conditions likely to impact on the advisability of radical radiotherapy, full anticoagulation, other exclusions to MRI (e.g. hip prosthesis or fixation, claustrophobia, ferromagnetic implants).
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 |
|---|---|---|
| Imaging Investigations (not radiation)Pre-hormone therapy MRI scans will be performed as an adjunct to the patients' staging MRI scan; post hormone MRI will be done wholly for research purposes. | Other | – |
| OtherInsertion of gold seeds into prostate for image registration. | Other | – |
Primary outcome
Comparison of dose distributions produced by rival radiotherapy plans judged using radiobiological model predictions of Tumour Control Probability (TCP) and Normal Tissue Complication Probability (NTCP).
4 secondary outcomes
Comparison of reproducibility of registration algorithms for mapping functional MR data acquired before hormone therapy to MR anatomical data acquired after hormone therapy and prior to radiotherapy.
Comparison of reproducibility of registration of functional and MR data with computed tomography (CT) data using gold seed registration, assessing reproducibility and positioning issues.
Comparison of image quality, registration reproducibility and gland distortion of internal and external imaging coils for MRI image acquisition and registration of the prostate.
Comparison of dose distributions produced by rival radiotherapy plans judged using three standard dose-volume constraints for targets and normal tissues and careful examination of the 3D dose distribution.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.
Dr Nandita deSouza principal investigator
CRUK Clinical Magnetic Resonance Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging Investigations (not radiation) and Other in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 2 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 3 Nov 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 United Kingdom. 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 Dr Nandita deSouza (02086613289, nandita.desouza@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of dose distributions produced by rival radiotherapy plans judged using radiobiological model predictions of Tumour Control Probability (TCP) and Normal Tissue Complication Probability (NTCP).. 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 3 Nov 2009.