Prostate AdenocarcinomaClarityNCT01478412
An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer
An observational study of Prostate Adenocarcinoma, run by John Chang, MD at 1 site in United States.
Trial summary
This trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion, and if alignment correction vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Polymer based fiducial placement
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to not given
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Members of all races and ethnic groups are eligible for this trial. Since this is a prostate study, only males will be enrolled.
Who may be able to join
- Histologically confirmed prostate adenocarcinoma
- diagnosis of low risk or intermediate risk prostate cancer
- approved for proton therapy treatment at CDH ProCure Proton Therapy Center
- prescribed and consented for the placement of fiducial markers into the prostate as part of the standard treatment procedure
- capable of receiving an MRI of the pelvis region for prostate localization
- the prostate gland of eligible patients must be capable of imaging from an anterior trans-abdominal ultrasound as determined by the treating investigator
- must be fluent in the English language; must be able to provide written study consent
Who cannot join
- Evidence of a large TURP defect per investigator discretion
- previous prostate cancer surgery including prostatectomy, hyperthermia and cryosurgery
- previous pelvic radiation for prostate cancer
- current grade 2 or above incontinence
- history of orthopedic procedures in the area of the treatment, specifically no prior hip replacement or procedure in which metallic or high density material remains which would be within stereoscopic kilovoltage imaging area
- prior permanent placement of any metallic or high density material within the prostate
- known allergy to ultrasonic gel
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
ProCure Proton Therapy Center
Warrenville, Illinois, 60555
Lori A Abruscato, BS, 630-821-6397, lori.abruscato@chi.procure.com
John Chang, MD
About this study
Official title: A Prospective Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer
This trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion, and if alignment correction vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.
Read the detailed description
The investigators will also be assessing the following:
- Whether polymer-based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers.
- Whether polymer-based markers are visible on ultrasound imaging.
- To determine if the polymer-based marker produces fewer artifacts on treatment planning CT scans than gold markers.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Polymer based fiducial placement
- Keywords
- Prostate cancer, Low risk, Intermediate risk, T1, T2a, T2b, Gleason 6, Gleason 7, PSA 10, PSA 20
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymer based fiducial placementOther
Fiducial marker placement with rectal ultrasound imaging.
| Study group | Role | What they receive |
|---|---|---|
| Males with prostate adenocarcinoma | English speaking males with histologically confirmed prostate adenocarcinoma and diagnosis of low risk or intermediate risk prostate cancer. Receives: Other: Polymer based fiducial placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound versus MRI image fusion for daily prostate positioning
Determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion method, and if alighment crrection vectors obtained from ultransound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.
Measured: 4 months
Secondary outcomes (1)
Polymer based marker visualization
To determine if polymer based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies 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
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Chang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Chang, MD, ProCure Proton Therapy Center
- Investigators
- John Chang, MD, Principal investigator, ProCure Proton Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478412
- Sponsor's protocol ID
- CHI-001
- Acronym
- Clarity
- Status last verified
- Dec 2011
- First submitted
- 21 Nov 2011
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer
- ClinicalTrials.gov ID
- NCT01478412
- Acronym / sponsor ID
- Clarity / CHI-001
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Prostate cancer, Low risk, Intermediate risk, T1, T2a, T2b, Gleason 6, Gleason 7
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- John Chang, MDUniversity, hospital or other
- Study start
- Dec 2011
- First posted
- 23 Nov 2011 (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.
This trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion, and if alignment correction vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.
Detailed description
The investigators will also be assessing the following:
- Whether polymer-based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers.
- Whether polymer-based markers are visible on ultrasound imaging.
- To determine if the polymer-based marker produces fewer artifacts on treatment planning CT scans than gold markers.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males with prostate adenocarcinoma | – | Other: Polymer based fiducial placementEnglish speaking males with histologically confirmed prostate adenocarcinoma and diagnosis of low risk or intermediate risk prostate cancer. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Members of all races and ethnic groups are eligible for this trial. Since this is a prostate study, only males will be enrolled.
Key inclusion criteria (7 listed)
- Histologically confirmed prostate adenocarcinoma
- diagnosis of low risk or intermediate risk prostate cancer
- approved for proton therapy treatment at CDH ProCure Proton Therapy Center
- prescribed and consented for the placement of fiducial markers into the prostate as part of the standard treatment procedure
- capable of receiving an MRI of the pelvis region for prostate localization
Key exclusion criteria (7 listed)
- Evidence of a large TURP defect per investigator discretion
- previous prostate cancer surgery including prostatectomy, hyperthermia and cryosurgery
- previous pelvic radiation for prostate cancer
- current grade 2 or above incontinence
- history of orthopedic procedures in the area of the treatment, specifically no prior hip replacement or procedure in which metallic or high density material remains which would be within stereoscopic kilovoltage imaging area
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 |
|---|---|---|
| Polymer based fiducial placementFiducial marker placement with rectal ultrasound imaging. | Other | Males with prostate adenocarcinoma |
Primary outcome
Ultrasound versus MRI image fusion for daily prostate positioning
Time frame: 4 months
Determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion method, and if alighment crrection vectors obtained from ultransound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.
1 secondary outcome
Polymer based marker visualization
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
- ProCure Proton Therapy CenterLink provided by the sponsor.
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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.
John Chang, MD principal investigator
ProCure Proton Therapy Center
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 Adenocarcinoma, run by John Chang, MD at 1 site in United States.
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 7 inclusion and 7 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 7 Dec 2011. 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 States. 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 Lori A Abruscato, BS (630-821-6397, lori.abruscato@chi.procure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound versus MRI image fusion for daily prostate positioning (time frame: 4 months). 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 7 Dec 2011.