Adenocarcinoma of the ProstateNCT01408706
The Prostate Immobilization Device Study
A study testing Miller Air tip and Radiadyne Immobilizer in people with Adenocarcinoma of the Prostate, run by James Taylor at 1 site in United States.
Trial summary
The purpose of this study is to compare reproducibility of the device position and location of the prostate rectum interface between two immobilization devices for radiation therapy of prostate carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Miller Air tip and Radiadyne Immobilizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 18 years of age or older
- Clinically localized T1-3 N0-1 M0 adenocarcinoma of the prostate
- Planned definitive radiation therapy
Who cannot join
- Prior proctectomy
- Rectal surgery within one year
- Proctitis
- Rectal carcinoma
- Anal Stenosis
- History of inflammatory bowel disease
Show all 9Show fewer
- Scleroderma
- Systemic sclerosis
- Refusal of treatment with immobilization device
Trial locations and contacts
1 site in 1 country.
United States1 site
Wheaton Francsican Cancer Care - All Saints
Racine, Wisconsin, 53405
About this study
The purpose of this study is to compare reproducibility of the device position and location of the prostate rectum interface between two immobilization devices for radiation therapy of prostate carcinoma.
Read the detailed description
The investigator assessed the device position and location of the interface between rectum and prostate weekly during the course of treatment. This information was obtained using a conebeam CT scan on the treatment couch prior to a regularly scheduled radiation treatment. The conebeam CT scan is a standard tool for monitoring patient position and radiation treatment accuracy. Prior to each radiation treatment, the patient was placed in a vaclock immobilization device, then aligned with room lasers to skin tattoos. On board portal imaging was then employed using the KvKv match technique to place isocenter as simulated. For intact prostate treatment, alignment was made to implanted gold fiducial markers. For post prostatectomy patients, the alignment was to pelvic bony anatomy. After patient alignment was complete, a conebeam CT scan was obtained. The position of the anterior rectal wall and the interface between prostate and rectum was compared to the position of these structures at the time of simulation. Measurement was taken in the midline of the prostate gland between its base and apex of the maximum deviation of the rectum prostate interface from its position at the time of simulation. For post prostatectomy patients, a measurement was taken of the maximum deviation from simulation of interface between the rectum and the prostate bed/bladder. These measurements were recorded weekly by the treating radiation oncologist on the Physician Data Sheet.
The difficulty of device insertion, positioning and inflation was recorded daily by the treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(unable to insert). These results were summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary.
Patient expression of discomfort during device placement was recorded daily by treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(intolerable). These responses will be summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Miller Air tip, Radiadyne Immobilizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miller Air tipDevice
Also called Miller Enema Air Tip
Miller Enema Air Tip is inserted into rectum prior to simulation and each radiation treatment.
Radiadyne ImmobilizerDevice
Radiadyne Immobilizer is inserted into rectum prior to simulation and each radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| Miller enema air tip | Active comparator | The Miller enema air tip rectal balloon is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy. Receives: Device: Miller Air tip |
| Radiadyne Immobilizer | Active comparator | The Radiadyne Immobilizer Treatment Device is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy Receives: Device: Radiadyne Immobilizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.
Measurements will be taken for at least 5, and up to 9, occasions on a weekly basis during each patient's course of treatment. An average value will be determined for each patient. An average of individual patient values will be determined for each immobilization device.
Measured: Up to 9 weeks
Secondary outcomes (2)
Difficulty of Insertion.
Difficulty of device insertion was scored for each treatment by the treating radiation therapist on a scale from 1(easiest) to 5(most difficult). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .
Measured: Up to nine weeks
Patient Expression of Discomfort
Patient expression of discomfort was scored for each insertion by the treating radiation therapist on a scale from 1(none) to 5(intolerable). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .
Measured: Up to nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the ProstateStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Taylor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, James Taylor, Wheaton Franciscan Healthcare
- Investigators
- James H Taylor, MD, Principal investigator, Wheaton Franciscan Cancer Care - All Saints
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408706
- Sponsor's protocol ID
- 11-019-ASH
- Status last verified
- Jun 2017
- First submitted
- 25 Jul 2011
- Last updated
- 29 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prostate Immobilization Device Study
- ClinicalTrials.gov ID
- NCT01408706
- Acronym / sponsor ID
- 11-019-ASH
- Conditions
- Adenocarcinoma of the Prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- James TaylorUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Posted 29 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare reproducibility of the device position and location of the prostate rectum interface between two immobilization devices for radiation therapy of prostate carcinoma.
Detailed description
The investigator assessed the device position and location of the interface between rectum and prostate weekly during the course of treatment. This information was obtained using a conebeam CT scan on the treatment couch prior to a regularly scheduled radiation treatment. The conebeam CT scan is a standard tool for monitoring patient position and radiation treatment accuracy. Prior to each radiation treatment, the patient was placed in a vaclock immobilization device, then aligned with room lasers to skin tattoos. On board portal imaging was then employed using the KvKv match technique to place isocenter as simulated. For intact prostate treatment, alignment was made to implanted gold fiducial markers. For post prostatectomy patients, the alignment was to pelvic bony anatomy. After patient alignment was complete, a conebeam CT scan was obtained. The position of the anterior rectal wall and the interface between prostate and rectum was compared to the position of these structures at the time of simulation. Measurement was taken in the midline of the prostate gland between its base and apex of the maximum deviation of the rectum prostate interface from its position at the time of simulation. For post prostatectomy patients, a measurement was taken of the maximum deviation from simulation of interface between the rectum and the prostate bed/bladder. These measurements were recorded weekly by the treating radiation oncologist on the Physician Data Sheet.
The difficulty of device insertion, positioning and inflation was recorded daily by the treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(unable to insert). These results were summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary.
Patient expression of discomfort during device placement was recorded daily by treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(intolerable). These responses will be summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miller enema air tip | Active comparator | Device: Miller Air tipThe Miller enema air tip rectal balloon is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy. |
| Radiadyne Immobilizer | Active comparator | Device: Radiadyne ImmobilizerThe Radiadyne Immobilizer Treatment Device is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Clinically localized T1-3 N0-1 M0 adenocarcinoma of the prostate
- Planned definitive radiation therapy
Key exclusion criteria (9 listed)
- Prior proctectomy
- Rectal surgery within one year
- Proctitis
- Rectal carcinoma
- Anal Stenosis
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 |
|---|---|---|
| Miller Air tipAlso: Miller Enema Air TipMiller Enema Air Tip is inserted into rectum prior to simulation and each radiation treatment. | Device | Miller enema air tip |
| Radiadyne ImmobilizerRadiadyne Immobilizer is inserted into rectum prior to simulation and each radiation treatment | Device | Radiadyne Immobilizer |
Primary outcome
Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.
Time frame: Up to 9 weeks
Measurements will be taken for at least 5, and up to 9, occasions on a weekly basis during each patient's course of treatment. An average value will be determined for each patient. An average of individual patient values will be determined for each immobilization device.
2 secondary outcomes
Difficulty of Insertion.
Time frame: Up to nine weeks
Patient Expression of Discomfort
Time frame: Up to nine weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Adenocarcinoma of the Prostate
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruiting
MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
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.
James H Taylor, MD principal investigator
Wheaton Franciscan Cancer Care - All Saints
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miller Air tip and Radiadyne Immobilizer in people with Adenocarcinoma of the Prostate, run by James Taylor 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 3 inclusion and 9 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 29 Jun 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?
Yes. Results are posted in the registry (first posted 29 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation. (time frame: Up to 9 weeks). 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 29 Jun 2017; AzTrials last refreshed its copy on 26 Oct 2026.