Prostate CancerNCT01260909
Real-Time MV/kV Image Guided Radiation Therapy
An observational study of Prostate Cancer, run by Stanford University.
Trial summary
In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose delivery typically takes 2 to 5 minutes depending on the delivery technique used for treatment. 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?
- Real-time kV/MV Prostate Imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2015
- 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: prostate cancer patients at Stanford University
Who may be able to join
- The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.
Who cannot join
- The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.
About this study
In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose delivery typically takes 2 to 5 minutes depending on the delivery technique used for treatment. A tumor target may change its position during the dose delivery process. The goal of this project is develop a real-time imaging strategy to monitor the tumor position during dose delivery and evaluate its potential clinical impact.
- Conditions
- Prostate Cancer
- Being tested
- Real-time kV/MV Prostate Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time kV/MV Prostate ImagingDevice
Also called Image-guided radiation therapy, External beam radiotherapy
The kV images will be acquired using onboard kV X-Ray imaging system existing in the clinical linear accelerator (LINAC).
| Study group | Role | What they receive |
|---|---|---|
| Real-time kV/MV Prostate Imaging | Not described Receives: Device: Real-time kV/MV Prostate Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify improved tumor targeting accuracy using IMRT (intensity modulated radiation therapy) and VMAT (volumetric modulated radiation therapy)
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 posted15 Dec 2010 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Why it stopped: Business decision
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 Stanford UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lei Xing, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260909
- Sponsor's protocol ID
- PROS0038
- Other IDs
- SU-12132010-7282, R21CA153587
- Status last verified
- Nov 2017
- First submitted
- 14 Dec 2010
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time MV/kV Image Guided Radiation Therapy
- ClinicalTrials.gov ID
- NCT01260909
- Acronym / sponsor ID
- PROS0038
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 15 Dec 2010 (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.
In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose delivery typically takes 2 to 5 minutes depending on the delivery technique used for treatment. A tumor target may change its position during the dose delivery process. The goal of this project is develop a real-time imaging strategy to monitor the tumor position during dose delivery and evaluate its potential clinical impact.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-time kV/MV Prostate Imaging | – | Device: Real-time kV/MV Prostate Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prostate cancer patients at Stanford University
Key inclusion criteria (1 listed)
- The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.
Key exclusion criteria (1 listed)
- The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.
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 |
|---|---|---|
| Real-time kV/MV Prostate ImagingAlso: Image-guided radiation therapy, External beam radiotherapyThe kV images will be acquired using onboard kV X-Ray imaging system existing in the clinical linear accelerator (LINAC). | Device | Real-time kV/MV Prostate Imaging |
Primary outcome
To verify improved tumor targeting accuracy using IMRT (intensity modulated radiation therapy) and VMAT (volumetric modulated radiation therapy)
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 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.
Lei Xing principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Stanford University.
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 1 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: withdrawn, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 verify improved tumor targeting accuracy using IMRT (intensity modulated radiation therapy) and VMAT (volumetric modulated radiation 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 Dec 2017.