The AIM Study: Assessing the Impact of Margin Reduction - Full Text View

Sponsored by:	Calypso Medical Technologies
Information provided by:	Calypso Medical Technologies
ClinicalTrials.gov Identifier:	NCT00754000

Purpose

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.

Condition	Intervention
Prostate Cancer	Other: Observation

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The AIM Study: Assessing the Impact of Margin Reduction

Further study details as provided by Calypso Medical Technologies:

Primary Outcome Measures:

Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Collection of patient tracking data from the Calypso 4D Localization System [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Evaluate the user satisfaction with the Calypso 4D Localization System [ Time Frame: At time of use ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	July 2008

Groups/Cohorts	Assigned Interventions
Cohort 1 All patients in study	Other: Observation AE monitoring and EPIC QOL survey

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Males diagnosed with prostate cancer

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754000

Locations

United States, Arizona
21st Century Oncology - Scottsdale	Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Lynn Bessette 480-945-6896
Principal Investigator: Scott Tropper, MD
United States, California
21st Century Oncology - Santa Monica	Recruiting
Santa Monica, California, United States, 90404
Contact: Shane Miller 310-828-0061
Principal Investigator: David Khan, MD
United States, Florida
21st Century Oncology	Recruiting
Cape Coral, Florida, United States, 33990
Contact: Constantine Mantz, MD 239-772-3202
Principal Investigator: Constantine Mantz, MD
21st Century Oncology - Plantation	Recruiting
Plantation, Florida, United States, 33324
Contact: Peter Clark 954-370-7555
Principal Investigator: Eduardo Fernandez, MD, PhD

Sponsors and Collaborators

Calypso Medical Technologies

Investigators

Principal Investigator:

Constantine Mantz, MD

21st Century Oncology

More Information

Publications:

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.

Zelefsky 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.

Zietman 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.

Chandra 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.

Michalski 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.

Rudat 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.

Antolak 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.

Little 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.

Smitsmans 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.

Litzenberg 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. Epub 2006 Mar 20.

Balter 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.

Litzenberg 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. Epub 2007 May 21.

Chandra 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.

Trotti 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. Review.

Wei 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.

Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61.

Responsible Party:	Calypso Medical Technologies, Inc. ( Dave Hammond )
Study ID Numbers:	CMT-03-08
Study First Received:	September 15, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00754000
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009