Prostate CancerPTVNCT01589939
Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System
An observational study of Prostate Cancer, run by U.S. Army Medical Research Acquisition Activity at 1 site in United States.
Trial summary
This prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2017
- 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 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with localized prostate cancer for whom definitive radiation therapy is planned to the prostate only or prostate and seminal vesicle only, without ajuvant or neoadjuvant hormornal therpy will be referred by the radiation oncololgists and urologists.
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Low Risk: T1a, T1b, T1c, T2a; Gleason Score less than 7, PSA less than or equal to 10
- Intermediate Risk: T2b, T2c; Gleason Score less than or equal to 7, PSA less than or equal to 15
- Ability to comply with study schedule
- Age 40 or older
- Zubrod PS 0 or 1
- Signed informed consent
Who cannot join
- Node positive or metastatic prostate cancer
- Prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or brachytherapy
- History of prior pelvic radiotherapy
- History of abdominoperineal resection
- History of HIV infection
- History of chronic prostatitis or chronic cystitis
Show all 12Show fewer
- History of bleeding disorder or any active anticoagulation (excluding ASA)
- PT or INR outside normal range for institution
- Active implanted devices such as cardiac pacemakers and automatic defibrillators.
- Prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip).
- Patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for Calypso System, see appendix 8).
- Prior history of androgen deprivation therapy has been deleted and these patients are allowed on study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study
This prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. Subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. Hypothesis: 1. Treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced PTV margin will result in a significant decrease in rectal and bladder volume treated.
Read the detailed description
This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including:
- decreased acute and chronic adverse effects with similar local tumor control
- dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment
- hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects.
- Conditions
- Prostate Cancer
- Keywords
- Reduced Planning Target Volume, radiation therapy, Calypso
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use
During each radiation treatment fraction, therapists will record set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) as well as the duration of the intervention caused by organ/target motion beyond planning target volume (PTV) margin using real time localization and tracking.
Measured: Approximately 8.5 weeks (43 fractions per pt.)
Secondary outcomes (2)
Analyze dosimetric characteristics of treatment planning
Standard methods vs. reduced planning target volume expansions will be analyzed:
- Dose Volume Histogram (DVH), bladder and rectum
- Volume receiving 77.4Gy by the prescription dose (V77.4Gy), V70Gy, and V50Gy of bladder and rectum
Measured: usually within the first 2 weeks after beacon placement (done at simulation CT)
Assess incidence of acute bladder and rectal toxicity
toxicity is based on the RTOG/NCI CTC and EPIC quality of life survey.
Measured: approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMar 2009
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research Acquisition Activity
- Sponsor type
- US federal agency
- Collaborators
- The Geneva Foundation
- Responsible party
- Principal investigator, Dusten Macdonald, MD, Madigan Army Medical Center
- Investigators
- Dusten Macdonald, MD, Principal investigator, Department of the Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589939
- Sponsor's protocol ID
- W81XWH-08-2-0174, A-15214.1a
- Other IDs
- 207111
- Acronym
- PTV
- Status last verified
- May 2016
- First submitted
- 26 Apr 2012
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01589939
- Acronym / sponsor ID
- PTV / W81XWH-08-2-0174, A-15214.1a
- Conditions
- Prostate Cancer
- Keywords
- Reduced Planning Target Volume, radiation therapy, Calypso
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research Acquisition ActivityUS federal agency
- Collaborators
- The Geneva Foundation
- Study start
- Mar 2009
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 2 May 2012 (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 prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. Subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. Hypothesis: 1. Treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced PTV margin will result in a significant decrease in rectal and bladder volume treated.
Detailed description
This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including:
- decreased acute and chronic adverse effects with similar local tumor control
- dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment
- hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with localized prostate cancer for whom definitive radiation therapy is planned to the prostate only or prostate and seminal vesicle only, without ajuvant or neoadjuvant hormornal therpy will be referred by the radiation oncololgists and urologists.
Key inclusion criteria (7 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Low Risk: T1a, T1b, T1c, T2a; Gleason Score less than 7, PSA less than or equal to 10
- Intermediate Risk: T2b, T2c; Gleason Score less than or equal to 7, PSA less than or equal to 15
- Ability to comply with study schedule
- Age 40 or older
Key exclusion criteria (12 listed)
- Node positive or metastatic prostate cancer
- Prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or brachytherapy
- History of prior pelvic radiotherapy
- History of abdominoperineal resection
- History of HIV infection
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
Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use
Time frame: Approximately 8.5 weeks (43 fractions per pt.)
During each radiation treatment fraction, therapists will record set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) as well as the duration of the intervention caused by organ/target motion beyond planning target volume (PTV) margin using real time localization and tracking.
2 secondary outcomes
Analyze dosimetric characteristics of treatment planning
Time frame: usually within the first 2 weeks after beacon placement (done at simulation CT)
Assess incidence of acute bladder and rectal toxicity
Time frame: approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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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.
Dusten Macdonald, MD principal investigator
Department of the Army
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 U.S. Army Medical Research Acquisition Activity 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 12 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 17 May 2016. 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?
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?
Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use (time frame: Approximately 8.5 weeks (43 fractions per pt.)). 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 17 May 2016.