The AIM Study: Assessing the Impact of Margin Reduction

Prostate Cancer Clinical Trial

— AIM  

Official title:

The AIM Study: Assessing the Impact of Margin Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754000
• Other study ID #: CMT-03-08
• Status: Completed
• Phase: N/A
• First received: September 15, 2008
• Last updated: April 27, 2012
• Start date: July 2008
• Est. completion date: September 2009

Study information

• Verified date: April 2012
• Source: Varian Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who are planning to receive external beam radiation of prostate

2. Patients who are to be implanted with Beacon Transponders in the prostate

3. 18 years of age or older.

4. Histologically confirmed diagnosis of prostate cancer.

5. Ability to comply with study visit schedule.

6. Signed informed consent form.

Exclusion Criteria:

1. Any patients who have received other investigational therapy within the last 60 days are excluded.

2. Individuals that have previously been implanted with permanent Beacon transponders are excluded.

3. Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).

4. Any other medical or other condition that would, at the discretion of the investigator, preclude the individual from participation in a clinical study.

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Other:
• Observation
AE monitoring and EPIC QOL survey

Locations

Country	Name	City	State
United States	21st Century Oncology	Cape Coral	Florida
United States	21st Century Oncology - Plantation	Plantation	Florida
United States	21st Century Oncology - Santa Monica	Santa Monica	California
United States	21st Century Oncology - Scottsdale	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Varian Medical

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pollack A. "The Prostate" in Radiation Oncology: Rationale, Techniques and Results edited by Cox and Ang. Mosby 2003 p 630.

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. — View Citation

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. doi: 10.1056/NEJMoa074311. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: JAMA. 2008 Feb 27;299(8):899-900. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL		2 year follow-up
Secondary	Collection of patient tracking data from the Calypso 4D Localization System		9 weeks
Secondary	Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan		9 weeks
Secondary	Evaluate the user satisfaction with the Calypso 4D Localization System		At time of use
Secondary	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		2 year follow-up