Evaluation of Clarity Ultrasound Guidance for Prostate Therapy (Clarity-Pro)

June 18, 2018 updated by: Institute of Cancer Research, United Kingdom

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing radiotherapy for prostate cancer

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Clarity ultrasound
Ultrasound imaging data will be recorded only. Treatment will not be altered as a result of this study.
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.
Device: Clarity ultrasound
Ultrasound imaging data will be recorded only. Treatment will not be altered as a result of this study.
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.
Device: Clarity ultrasound
Ultrasound imaging data will be recorded only. Treatment will not be altered as a result of this study.
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.
Device: Clarity ultrasound
Ultrasound imaging data will be recorded only. Treatment will not be altered as a result of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Outcome measures will be assessed for each patient during radiotherapy, an average of five weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Emma Harris, Institute of Cancer Research, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2015

Primary Completion (Actual)

June 18, 2018

Study Completion (Actual)

June 18, 2018

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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