Prostate CancerClarity-ProNCT02388308
Evaluation of Clarity Ultrasound Guidance for Prostate Therapy
An observational study of Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
Radiotherapy (RT) is an important treatment for prostate cancer with over 10,000 men receiving RT per year in the UK. Prostate RT aims to deliver radiation dose to the prostate to kill cancer cells whilst minimizing the dose given to surrounding normal tissues, such as the bladder or the rectum. 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?
- Clarity ultrasound
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2015to 18 Jun 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing radiotherapy for prostate cancer
Who may be able to join
- Two patient groups and two patient volunteer groups will be recruited:
- Groups 1: Patient volunteers who have received radiotherapy for prostate cancer which included a planning CT scan, or who are currently receiving radiotherapy.
- Groups 2 and 3:
- Patients receiving radiotherapy for prostate cancer as part of a clinical trial or standard care which includes gold FM or EM insertion
- Patients who have previously received RT for prostate cancer which included EM insertion.
- Group 4: Patients who are receiving radiotherapy for prostate cancer and who are not receiving FMs. Attempts will be made to match Group 4 patients BMI and time receiving hormone therapy to patients in group 2 and 3 (see below, section 6.1 recruitment.
Who cannot join
- Groups 1 to 4: Patients who have received prostatectomy.
- Groups 2 and 4: Patients receiving less than 6 RT fractions.
- Group 4 only: Patients who have received FMs or EMs.
Trial locations and contacts
1 site in 1 country.
About this study
Radiotherapy (RT) is an important treatment for prostate cancer with over 10,000 men receiving RT per year in the UK. Prostate RT aims to deliver radiation dose to the prostate to kill cancer cells whilst minimizing the dose given to surrounding normal tissues, such as the bladder or the rectum. Radiation is delivered in a number of daily treatments which are called 'fractions'. The position of the prostate varies each day and during the radiation delivery. To accurately aim the radiation the prostate needs to be located before daily treatment. Clarity is an ultrasound image guidance system that locates the prostate and monitors its position during treatment. Ultrasound does not give a radiation dose, is non-invasive, provides fast imaging and can easily visualise soft tissues. Before Clarity is implemented the investigators wish to ensure that it can accurately locate and monitor the prostate by comparing Clarity with marker-based techniques in 24 patients. Patients receive markers as part of other trials which are currently recruiting at The Royal Marsden (for example, patients in the DELINEATE trial and the PACE trials receive implanted gold markers and patients in the PROSPARE trial have received electromagnetic markers). Patients who have received or will be receiving markers as part of other studies will be asked to also to take part in this study. This means that there will be no additional intervention for patients as a result of this study. Clarity will be considered a safe and effective imaging system if the mean and standard deviation of the differences between Clarity measurements and marker measurements, of prostate position, are less than 1mm. It is possible that markers will influence the Clarity measurements. To find out if this happens, the mean and standard deviation of Clarity measurements in a group of 24 patients without markers to the group with markers will be compared.
Primary Aim: To evaluate the accuracy of Clarity ultrasound image guidance system for prostate motion estimation during treatment (intra-fraction), by comparison with implanted marker-based image guidance techniques.
Primary Hypothesis: Clarity can be safely used to deliver radiotherapy using similar (within 1mm) treatment margins to those that would be employed if fiducial markers based image guidance techniques were used.
- Conditions
- Prostate Cancer
- Being tested
- Clarity ultrasound
- Keywords
- Prostate cancer, Image-guided radiotherapy, Ultrasound guidance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarity ultrasoundDevice
Ultrasound imaging data will be recorded only. Treatment will not be altered as a result of this study.
| Study group | Role | What they receive |
|---|---|---|
| Patient volunteers | Patients who have received radiotherapy for prostate cancer which included a planning CT scan, or who are currently receiving radiotherapy including a CT scan. Receives: Device: Clarity ultrasound | |
| Gold fiducial marker group | Patients receiving radiotherapy for prostate cancer as part of a clinical trial or standard care which includes gold FM or EM insertion, or patients who have previously received RT for prostate cancer which included EM insertion. Receives: Device: Clarity ultrasound | |
| Electromagnetic marker group | Patients receiving radiotherapy for prostate cancer as part of a clinical trial or standard care which includes gold FM or EM insertion, or patients who have previously received RT for prostate cancer which included EM insertion. Receives: Device: Clarity ultrasound | |
| General patients | Patients who are receiving radiotherapy for prostate cancer and who are not receiving FMs. Attempts will be made to match Group 4 patients BMI and time receiving hormone therapy to patients in group 2 and 3 (see below, section 6.1 recruitment. Receives: Device: Clarity ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate position (measured in millimeters) measured using Clarity ultrasound and implanted fiducial markers
Mean (and standard deviation) of the differences in prostate position determined using Clarity and that determined using fiducial marker based image guidance during radiotherapy delivery.
Measured: Outcome measures will be assessed for each patient during radiotherapy, an average of five weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start15 May 2015
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
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 Institute of Cancer Research, United KingdomThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Emma Harris, Principal investigator, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388308
- Sponsor's protocol ID
- 4267
- Acronym
- Clarity-Pro
- Status last verified
- Jun 2018
- First submitted
- 20 Feb 2015
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Grimwood A, Rivaz H, Zhou H, McNair HA, Jakubowski K, Bamber JC, Tree AC, Harris EJ. Improving 3D ultrasound prostate localisation in radiotherapy through increased automation of interfraction matching. Radiother Oncol. 2020 Aug;149:134-141. doi: 10.1016/j.radonc.2020.04.044. Epub 2020 May 6.
PubMed 32387546Grimwood A, McNair HA, O'Shea TP, Gilroy S, Thomas K, Bamber JC, Tree AC, Harris EJ. In Vivo Validation of Elekta's Clarity Autoscan for Ultrasound-based Intrafraction Motion Estimation of the Prostate During Radiation Therapy. Int J Radiat Oncol Biol Phys. 2018 Nov 15;102(4):912-921. doi: 10.1016/j.ijrobp.2018.04.008. Epub 2018 Apr 16.
PubMed 29859785
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clarity Ultrasound Guidance for Prostate Therapy
- ClinicalTrials.gov ID
- NCT02388308
- Acronym / sponsor ID
- Clarity-Pro / 4267
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Image-guided radiotherapy, Ultrasound guidance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- 15 May 2015 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 17 Mar 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.
Radiotherapy (RT) is an important treatment for prostate cancer with over 10,000 men receiving RT per year in the UK. Prostate RT aims to deliver radiation dose to the prostate to kill cancer cells whilst minimizing the dose given to surrounding normal tissues, such as the bladder or the rectum. Radiation is delivered in a number of daily treatments which are called 'fractions'. The position of the prostate varies each day and during the radiation delivery. To accurately aim the radiation the prostate needs to be located before daily treatment. Clarity is an ultrasound image guidance system that locates the prostate and monitors its position during treatment. Ultrasound does not give a radiation dose, is non-invasive, provides fast imaging and can easily visualise soft tissues. Before Clarity is implemented the investigators wish to ensure that it can accurately locate and monitor the prostate by comparing Clarity with marker-based techniques in 24 patients. Patients receive markers as part of other trials which are currently recruiting at The Royal Marsden (for example, patients in the DELINEATE trial and the PACE trials receive implanted gold markers and patients in the PROSPARE trial have received electromagnetic markers). Patients who have received or will be receiving markers as part of other studies will be asked to also to take part in this study. This means that there will be no additional intervention for patients as a result of this study. Clarity will be considered a safe and effective imaging system if the mean and standard deviation of the differences between Clarity measurements and marker measurements, of prostate position, are less than 1mm. It is possible that markers will influence the Clarity measurements. To find out if this happens, the mean and standard deviation of Clarity measurements in a group of 24 patients without markers to the group with markers will be compared.
Primary Aim: To evaluate the accuracy of Clarity ultrasound image guidance system for prostate motion estimation during treatment (intra-fraction), by comparison with implanted marker-based image guidance techniques.
Primary Hypothesis: Clarity can be safely used to deliver radiotherapy using similar (within 1mm) treatment margins to those that would be employed if fiducial markers based image guidance techniques were used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient volunteers | – | Device: Clarity ultrasoundPatients who have received radiotherapy for prostate cancer which included a planning CT scan, or who are currently receiving radiotherapy including a CT scan. |
| Gold fiducial marker group | – | Device: Clarity ultrasoundPatients receiving radiotherapy for prostate cancer as part of a clinical trial or standard care which includes gold FM or EM insertion, or patients who have previously received RT for prostate cancer which included EM insertion. |
| Electromagnetic marker group | – | Device: Clarity ultrasoundPatients receiving radiotherapy for prostate cancer as part of a clinical trial or standard care which includes gold FM or EM insertion, or patients who have previously received RT for prostate cancer which included EM insertion. |
| General patients | – | Device: Clarity ultrasoundPatients who are receiving radiotherapy for prostate cancer and who are not receiving FMs. Attempts will be made to match Group 4 patients BMI and time receiving hormone therapy to patients in group 2 and 3 (see below, section 6.1 recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radiotherapy for prostate cancer
Key inclusion criteria (6 listed)
- Groups 1: Patient volunteers who have received radiotherapy for prostate cancer which included a planning CT scan, or who are currently receiving radiotherapy.
- Patients receiving radiotherapy for prostate cancer as part of a clinical trial or standard care which includes gold FM or EM insertion
- Patients who have previously received RT for prostate cancer which included EM insertion.
- Group 4: Patients who are receiving radiotherapy for prostate cancer and who are not receiving FMs. Attempts will be made to match Group 4 patients BMI and time receiving hormone therapy to patients in group 2 and 3 (see below, section 6.1 recruitment.
Key exclusion criteria (3 listed)
- Groups 1 to 4: Patients who have received prostatectomy.
- Groups 2 and 4: Patients receiving less than 6 RT fractions.
- Group 4 only: Patients who have received FMs or EMs.
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 |
|---|---|---|
| Clarity ultrasoundUltrasound imaging data will be recorded only. Treatment will not be altered as a result of this study. | Device | Electromagnetic marker group, General patients, Gold fiducial marker group, Patient volunteers |
Primary outcome
Prostate position (measured in millimeters) measured using Clarity ultrasound and implanted fiducial markers
Time frame: Outcome measures will be assessed for each patient during radiotherapy, an average of five weeks.
Mean (and standard deviation) of the differences in prostate position determined using Clarity and that determined using fiducial marker based image guidance during radiotherapy delivery.
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 19 Jun 2018.
- Derived from this study: PubMed 32387546Grimwood A, Rivaz H, Zhou H, McNair HA, Jakubowski K, Bamber JC, Tree AC, Harris EJ. Improving 3D ultrasound prostate localisation in radiotherapy through increased automation of interfraction matching. Radiother Oncol. 2020 Aug;149:134-141. doi: 10.1016/j.radonc.2020.04.044. Epub 2020 May 6.
- Derived from this study: PubMed 29859785Grimwood A, McNair HA, O'Shea TP, Gilroy S, Thomas K, Bamber JC, Tree AC, Harris EJ. In Vivo Validation of Elekta's Clarity Autoscan for Ultrasound-based Intrafraction Motion Estimation of the Prostate During Radiation Therapy. Int J Radiat Oncol Biol Phys. 2018 Nov 15;102(4):912-921. doi: 10.1016/j.ijrobp.2018.04.008. Epub 2018 Apr 16.
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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.
Emma Harris principal investigator
Institute of Cancer Research, United Kingdom
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 Institute of Cancer Research, United Kingdom 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 6 inclusion and 3 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 19 Jun 2018. 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?
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?
Prostate position (measured in millimeters) measured using Clarity ultrasound and implanted fiducial markers (time frame: Outcome measures will be assessed for each patient during radiotherapy, an average of five weeks.). 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 NCT02388308, 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 19 Jun 2018.