Prostate CancerNCT02408497
Use of Non-invasive 4D Ultrasound Clarity System in Prostate IMRT/RapidArc Therapy
An observational study of Prostate Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
A single arm phase II study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2015to Dec 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate cancer patients who are going to receive IMRT/RapidArc therapy at site and are not participating any other clinical studies.
Who may be able to join
- Patient must be able to provide study-specific informed consent prior to study entry.
Who cannot join
- Patient who cannot abide to the departmental hydration protocol
- Prostatectomy cases
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol requires contact of ultrasound probe to the perineum area.
- Patient enrolled in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of Non-invasive 4D Ultrasound Clarity System in Real-time Tracking of the Target Volume in Prostate IMRT/RapidArc Therapy
A single arm phase II study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT.
Read the detailed description
Primarily, this is a single arm phase I study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) or Volumetric Modulated Arc therapy (VMAT) with the aid of volumetric image guidance to ensure accuracy and real-time 3D ultrasound images as observational record of the prostate motion. All the recruited patients are prescribed and treated with either VMAT or IMRT treatment. In order to simulate the behaviour of prostate motion in an IMRT scenario, the group of VMAT patients will be required to remain in treatment position for an additional 7 minutes depending on techniques used (once a week).
In order to assess the level of acceptance of the treatment position, responses to the same comfort survey for the current treatment position (i.e. using leg immobiliser) by a cohort of 60 patients treated in another IGRT treatment room will be used as the baseline. In addition, RTT satisfaction questionnaire will also be administered to assess the handling of the new immobilizer.
Acute toxicity will be measured at preset intervals using CTCAE version 3.0 and as will International prostate symptom score (IPSS) questionnaire which focuses on urinary symptoms. Symptoms or toxicities reported from this study is relevant for patients treated with IMRT or VMAT with full bladder protocol.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of intra-fraction prostate motion using an ultrasound system during IMRT and during RapidArc therapy
Measured: 2 years
Secondary outcomes (4)
The 3D ultrasound capability of the Clarity® system (from Elekta AB Stockholm, Sweden) in providing real-time information of the prostate movement during the treatment delivery
Measured: 2 years
The efficacy of full bladder protocol for patient undergoing prostate radiotherapy
Measured: 2 years
The rate of acute GI and GU side effects within 3 months (<90 days) after radical radiotherapy
Measured: 2 years
Patient comfort, compliance and tolerance of two setup techniques
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Kit Long Tuan, Dr, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408497
- Sponsor's protocol ID
- NCC DRO 4D-us CS
- Status last verified
- Aug 2017
- First submitted
- 31 Mar 2015
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Non-invasive 4D Ultrasound Clarity System in Real-time Tracking of the Target Volume in Prostate IMRT/RapidArc Therapy
- ClinicalTrials.gov ID
- NCT02408497
- Acronym / sponsor ID
- NCC DRO 4D-us CS
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Apr 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.
A single arm phase II study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT.
Detailed description
Primarily, this is a single arm phase I study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) or Volumetric Modulated Arc therapy (VMAT) with the aid of volumetric image guidance to ensure accuracy and real-time 3D ultrasound images as observational record of the prostate motion. All the recruited patients are prescribed and treated with either VMAT or IMRT treatment. In order to simulate the behaviour of prostate motion in an IMRT scenario, the group of VMAT patients will be required to remain in treatment position for an additional 7 minutes depending on techniques used (once a week).
In order to assess the level of acceptance of the treatment position, responses to the same comfort survey for the current treatment position (i.e. using leg immobiliser) by a cohort of 60 patients treated in another IGRT treatment room will be used as the baseline. In addition, RTT satisfaction questionnaire will also be administered to assess the handling of the new immobilizer.
Acute toxicity will be measured at preset intervals using CTCAE version 3.0 and as will International prostate symptom score (IPSS) questionnaire which focuses on urinary symptoms. Symptoms or toxicities reported from this study is relevant for patients treated with IMRT or VMAT with full bladder protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer patients who are going to receive IMRT/RapidArc therapy at site and are not participating any other clinical studies.
Key inclusion criteria (1 listed)
- Patient must be able to provide study-specific informed consent prior to study entry.
Key exclusion criteria (4 listed)
- Patient who cannot abide to the departmental hydration protocol
- Prostatectomy cases
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol requires contact of ultrasound probe to the perineum area.
- Patient enrolled in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The extent of intra-fraction prostate motion using an ultrasound system during IMRT and during RapidArc therapy
Time frame: 2 years
4 secondary outcomes
The 3D ultrasound capability of the Clarity® system (from Elekta AB Stockholm, Sweden) in providing real-time information of the prostate movement during the treatment delivery
Time frame: 2 years
The efficacy of full bladder protocol for patient undergoing prostate radiotherapy
Time frame: 2 years
The rate of acute GI and GU side effects within 3 months (<90 days) after radical radiotherapy
Time frame: 2 years
Patient comfort, compliance and tolerance of two setup techniques
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
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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.
Jeffrey Kit Long Tuan, Dr principal investigator
National Cancer Centre, Singapore
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 National Cancer Centre, Singapore at 1 site in Singapore.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Aug 2017. 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 Singapore. 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?
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?
The extent of intra-fraction prostate motion using an ultrasound system during IMRT and during RapidArc therapy (time frame: 2 years). 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 2 Aug 2017.