Prostate CancerNCT01810627
Application of Megavoltage Imaging to Reduce Artifact After Seed Implants
An observational study of Prostate Cancer, run by William St Clair at 1 site in United States.
Trial summary
This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure in patients treated with interstitial permanent seed implants for low and intermediate risk prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MVCT
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2016
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male 50-80 years of age Eligible for interstitial brachytherapy implants
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Megavoltage Imaging to Reduce Artifact Following Interstitial Seed Implants for Prostate Adenocarcinoma
This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure in patients treated with interstitial permanent seed implants for low and intermediate risk prostate cancer. All patients will received the same standard of care treatment but will receive an additinoal CT image of the prostate.
- Conditions
- Prostate Cancer
- Being tested
- MVCT
- Keywords
- Prostate, Cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVCTRadiation
Patients will receive an additional MVCT scan at their one month follow up visit.
| Study group | Role | What they receive |
|---|---|---|
| MVCT | Patients will receive an additional MVCT scan at their one month follow up visit. Receives: Radiation: MVCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prostate volume measured in cm^3
Change in prostate volume measured with trans-rectal ultrasound at baseline versus prostate volume measured with KVCT and MVCT.
Measured: One month post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2016
- Study completionApr 2016
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
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- William St Clair
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, William St Clair, University of Kentucky
- Investigators
- William St. Clair, MD, Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810627
- Sponsor's protocol ID
- 13-RAD-01
- Status last verified
- Sep 2017
- First submitted
- 11 Mar 2013
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Megavoltage Imaging to Reduce Artifact Following Interstitial Seed Implants for Prostate Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01810627
- Acronym / sponsor ID
- 13-RAD-01
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- William St ClairUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Mar 2013 (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 is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure in patients treated with interstitial permanent seed implants for low and intermediate risk prostate cancer. All patients will received the same standard of care treatment but will receive an additinoal CT image of the prostate.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MVCT | – | Radiation: MVCTPatients will receive an additional MVCT scan at their one month follow up visit. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male 50-80 years of age Eligible for interstitial brachytherapy implants
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MVCTPatients will receive an additional MVCT scan at their one month follow up visit. | Radiation | MVCT |
Primary outcome
Change in prostate volume measured in cm^3
Time frame: One month post implant
Change in prostate volume measured with trans-rectal ultrasound at baseline versus prostate volume measured with KVCT and MVCT.
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 26 Sep 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.
William St. Clair, MD principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
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 William St Clair 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 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: finished, as of the sponsor's last update on 26 Sep 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 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?
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?
Change in prostate volume measured in cm^3 (time frame: One month post implant). 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 26 Sep 2017.