Prostate CancerAIMNCT00754000
The AIM Study: Assessing the Impact of Margin Reduction
An observational study of Prostate Cancer, run by Varian, a Siemens Healthineers Company at 4 sites in United States.
Trial summary
This study will observe patients who receive external beam radiation for prostate cancer. These patients will be localized and tracked (targeted) with the Calypso 4D Localization System. 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?
- Observation
- How many people
- 82 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2008to Sep 2009
- 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: Males diagnosed with prostate cancer
Who may be able to join
- Patients who are planning to receive external beam radiation of prostate
- Patients who are to be implanted with Beacon Transponders in the prostate
- 18 years of age or older.
- Histologically confirmed diagnosis of prostate cancer.
- Ability to comply with study visit schedule.
- Signed informed consent form.
Who cannot join
- Any patients who have received other investigational therapy within the last 60 days are excluded.
- Individuals that have previously been implanted with permanent Beacon transponders are excluded.
- Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
- Any other medical or other condition that would, at the discretion of the investigator, preclude the individual from participation in a clinical study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
21st Century Oncology
Cape Coral, Florida, 33990
21st Century Oncology - Plantation
Plantation, Florida, 33324
21st Century Oncology - Santa Monica
Santa Monica, California, 90404
21st Century Oncology - Scottsdale
Scottsdale, Arizona, 85251
About this study
This study will observe patients who receive external beam radiation for prostate cancer. These patients will be localized and tracked (targeted) with the Calypso 4D Localization System. These patients will have a uniform treatment plan with reduced PTVs (prostate treatment volume) and will be assessed at multiple time points for quality of life and side effects related to radiation therapy.
Read the detailed description
EPIC surveys and adverse events recorded and categorized using the CTCAE v3.0 will be collected and summary statistics performed. The patient's individual tracking graphs will be evaluated for motion type and frequency.
- Conditions
- Prostate Cancer
- Being tested
- Observation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Also called EPIC survey
AE monitoring and EPIC QOL survey
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | All patients in study Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL
Measured: 2 year follow-up
Secondary outcomes (4)
Collection of patient tracking data from the Calypso 4D Localization System
Measured: 9 weeks
Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan
Measured: 9 weeks
Evaluate the user satisfaction with the Calypso 4D Localization System
Measured: At time of use
Evaluate acute and chronic (up to 2 years) toxicities of external beam prostate radiation using Common Terminology Criteria for Adverse Events for standardization of acute and chronic toxicities from the subject
Measured: 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startJul 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Constantine Mantz, MD, Principal investigator, GenesisCare USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754000
- Sponsor's protocol ID
- CMT-03-08
- Acronym
- AIM
- Status last verified
- Apr 2012
- First submitted
- 15 Sep 2008
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pollack A. "The Prostate" in Radiation Oncology: Rationale, Techniques and Results edited by Cox and Ang. Mosby 2003 p 630.
Hanks GE, Leibel SA, Krall JM, Kramer S. Patterns of care studies: dose-response observations for local control of adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys. 1985 Jan;11(1):153-7. doi: 10.1016/0360-3016(85)90374-8.
PubMed 3967982Zelefsky MJ, Fuks Z, Hunt M, Yamada Y, Marion C, Ling CC, Amols H, Venkatraman ES, Leibel SA. High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 772 patients. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6. doi: 10.1016/s0360-3016(02)02857-2.
PubMed 12128109Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233.
PubMed 16160131Chandra A, Dong L, Huang E, Kuban DA, O'Neill L, Rosen I, Pollack A. Experience of ultrasound-based daily prostate localization. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):436-47. doi: 10.1016/s0360-3016(02)04612-6.
PubMed 12738318Michalski JM, Purdy JA, Winter K, Roach M 3rd, Vijayakumar S, Sandler HM, Markoe AM, Ritter MA, Russell KJ, Sailer S, Harms WB, Perez CA, Wilder RB, Hanks GE, Cox JD. Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406. Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):391-402. doi: 10.1016/s0360-3016(99)00443-5.
PubMed 10661346Rudat V, Schraube P, Oetzel D, Zierhut D, Flentje M, Wannenmacher M. Combined error of patient positioning variability and prostate motion uncertainty in 3D conformal radiotherapy of localized prostate cancer. Int J Radiat Oncol Biol Phys. 1996 Jul 15;35(5):1027-34. doi: 10.1016/0360-3016(96)00204-0.
PubMed 8751412Antolak JA, Rosen II, Childress CH, Zagars GK, Pollack A. Prostate target volume variations during a course of radiotherapy. Int J Radiat Oncol Biol Phys. 1998 Oct 1;42(3):661-72. doi: 10.1016/s0360-3016(98)00248-x.
PubMed 9806528Little DJ, Dong L, Levy LB, Chandra A, Kuban DA. Use of portal images and BAT ultrasonography to measure setup error and organ motion for prostate IMRT: implications for treatment margins. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1218-24. doi: 10.1016/s0360-3016(03)00290-6.
PubMed 12873664Smitsmans MH, de Bois J, Sonke JJ, Betgen A, Zijp LJ, Jaffray DA, Lebesque JV, van Herk M. Automatic prostate localization on cone-beam CT scans for high precision image-guided radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):975-84. doi: 10.1016/j.ijrobp.2005.07.973.
PubMed 16253772Litzenberg DW, Balter JM, Hadley SW, Sandler HM, Willoughby TR, Kupelian PA, Levine L. Influence of intrafraction motion on margins for prostate radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):548-53. doi: 10.1016/j.ijrobp.2005.12.033. Epub 2006 Mar 20.
PubMed 16545919Balter JM, Wright JN, Newell LJ, Friemel B, Dimmer S, Cheng Y, Wong J, Vertatschitsch E, Mate TP. Accuracy of a wireless localization system for radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):933-7. doi: 10.1016/j.ijrobp.2004.11.009.
PubMed 15708277Litzenberg DW, Willoughby TR, Balter JM, Sandler HM, Wei J, Kupelian PA, Cunningham AA, Bock A, Aubin M, Roach M 3rd, Shinohara K, Pouliot J. Positional stability of electromagnetic transponders used for prostate localization and continuous, real-time tracking. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1199-206. doi: 10.1016/j.ijrobp.2007.03.030. Epub 2007 May 21.
PubMed 17513060Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003 Jul;13(3):176-81. doi: 10.1016/S1053-4296(03)00031-6.
PubMed 12903007Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x.
PubMed 11113727
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AIM Study: Assessing the Impact of Margin Reduction
- ClinicalTrials.gov ID
- NCT00754000
- Acronym / sponsor ID
- AIM / CMT-03-08
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Sep 2008 (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 study will observe patients who receive external beam radiation for prostate cancer. These patients will be localized and tracked (targeted) with the Calypso 4D Localization System. These patients will have a uniform treatment plan with reduced PTVs (prostate treatment volume) and will be assessed at multiple time points for quality of life and side effects related to radiation therapy.
Detailed description
EPIC surveys and adverse events recorded and categorized using the CTCAE v3.0 will be collected and summary statistics performed. The patient's individual tracking graphs will be evaluated for motion type and frequency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: ObservationAll patients in study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males diagnosed with prostate cancer
Key inclusion criteria (6 listed)
- Patients who are planning to receive external beam radiation of prostate
- Patients who are to be implanted with Beacon Transponders in the prostate
- 18 years of age or older.
- Histologically confirmed diagnosis of prostate cancer.
- Ability to comply with study visit schedule.
Key exclusion criteria (4 listed)
- Any patients who have received other investigational therapy within the last 60 days are excluded.
- Individuals that have previously been implanted with permanent Beacon transponders are excluded.
- Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
- Any other medical or other condition that would, at the discretion of the investigator, preclude the individual from participation in a clinical study.
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 |
|---|---|---|
| ObservationAlso: EPIC surveyAE monitoring and EPIC QOL survey | Other | Cohort 1 |
Primary outcome
Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL
Time frame: 2 year follow-up
4 secondary outcomes
Collection of patient tracking data from the Calypso 4D Localization System
Time frame: 9 weeks
Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan
Time frame: 9 weeks
Evaluate the user satisfaction with the Calypso 4D Localization System
Time frame: At time of use
Evaluate acute and chronic (up to 2 years) toxicities of external beam prostate radiation using Common Terminology Criteria for Adverse Events for standardization of acute and chronic toxicities from the subject
Time frame: 2 year follow-up
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 30 Apr 2012.
- BackgroundPollack A. "The Prostate" in Radiation Oncology: Rationale, Techniques and Results edited by Cox and Ang. Mosby 2003 p 630.
- Background: PubMed 3967982Hanks GE, Leibel SA, Krall JM, Kramer S. Patterns of care studies: dose-response observations for local control of adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys. 1985 Jan;11(1):153-7. doi: 10.1016/0360-3016(85)90374-8.
- Background: PubMed 12128109Zelefsky MJ, Fuks Z, Hunt M, Yamada Y, Marion C, Ling CC, Amols H, Venkatraman ES, Leibel SA. High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 772 patients. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6. doi: 10.1016/s0360-3016(02)02857-2.
- Background: PubMed 16160131Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233.
- Background: PubMed 12738318Chandra A, Dong L, Huang E, Kuban DA, O'Neill L, Rosen I, Pollack A. Experience of ultrasound-based daily prostate localization. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):436-47. doi: 10.1016/s0360-3016(02)04612-6.
- Background: PubMed 10661346Michalski JM, Purdy JA, Winter K, Roach M 3rd, Vijayakumar S, Sandler HM, Markoe AM, Ritter MA, Russell KJ, Sailer S, Harms WB, Perez CA, Wilder RB, Hanks GE, Cox JD. Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406. Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):391-402. doi: 10.1016/s0360-3016(99)00443-5.
- Background: PubMed 8751412Rudat V, Schraube P, Oetzel D, Zierhut D, Flentje M, Wannenmacher M. Combined error of patient positioning variability and prostate motion uncertainty in 3D conformal radiotherapy of localized prostate cancer. Int J Radiat Oncol Biol Phys. 1996 Jul 15;35(5):1027-34. doi: 10.1016/0360-3016(96)00204-0.
- Background: PubMed 9806528Antolak JA, Rosen II, Childress CH, Zagars GK, Pollack A. Prostate target volume variations during a course of radiotherapy. Int J Radiat Oncol Biol Phys. 1998 Oct 1;42(3):661-72. doi: 10.1016/s0360-3016(98)00248-x.
- Background: PubMed 12873664Little DJ, Dong L, Levy LB, Chandra A, Kuban DA. Use of portal images and BAT ultrasonography to measure setup error and organ motion for prostate IMRT: implications for treatment margins. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1218-24. doi: 10.1016/s0360-3016(03)00290-6.
- Background: PubMed 16253772Smitsmans MH, de Bois J, Sonke JJ, Betgen A, Zijp LJ, Jaffray DA, Lebesque JV, van Herk M. Automatic prostate localization on cone-beam CT scans for high precision image-guided radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):975-84. doi: 10.1016/j.ijrobp.2005.07.973.
- Background: PubMed 16545919Litzenberg DW, Balter JM, Hadley SW, Sandler HM, Willoughby TR, Kupelian PA, Levine L. Influence of intrafraction motion on margins for prostate radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):548-53. doi: 10.1016/j.ijrobp.2005.12.033. Epub 2006 Mar 20.
- Background: PubMed 15708277Balter JM, Wright JN, Newell LJ, Friemel B, Dimmer S, Cheng Y, Wong J, Vertatschitsch E, Mate TP. Accuracy of a wireless localization system for radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):933-7. doi: 10.1016/j.ijrobp.2004.11.009.
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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.
Constantine Mantz, MD principal investigator
GenesisCare USA
4 sites 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 Varian, a Siemens Healthineers Company at 4 sites 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 6 inclusion and 4 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL (time frame: 2 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754000, which also lists 16 linked publications.
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 30 Apr 2012.