The AIM Study: Assessing the Impact of Margin Reduction

NCT00754000 | Completed

• 1 other identifier: CMT-03-08
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL

  2 year follow-up

Secondary Outcomes (4)

• Collection of patient tracking data from the Calypso 4D Localization System

  9 weeks

• Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan

  9 weeks

• Evaluate the user satisfaction with the Calypso 4D Localization System

  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

  2 year follow-up

Study Arms (1)

Cohort 1

All patients in study

Other: Observation

Interventions

Observation OTHER

AE monitoring and EPIC QOL survey

Also known as: EPIC survey

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males diagnosed with prostate cancer

You may qualify if:

• Patients who are planning to receive external beam radiation of prostate
• Patients who are to be implanted with Beacon Transponders in the prostate
• years of age or older.
• Histologically confirmed diagnosis of prostate cancer.
• Ability to comply with study visit schedule.
• Signed informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (4)

21st Century Oncology - Scottsdale

Scottsdale, Arizona, 85251, United States

Location

21st Century Oncology - Santa Monica

Santa Monica, California, 90404, United States

Location

21st Century Oncology

Cape Coral, Florida, 33990, United States

Location

21st Century Oncology - Plantation

Plantation, Florida, 33324, United States

Location

Related Publications (16)

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

  BACKGROUND

• 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.

  PMID: 3967982 BACKGROUND

• 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. doi: 10.1016/s0360-3016(02)02857-2.

  PMID: 12128109 BACKGROUND

• 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. doi: 10.1001/jama.294.10.1233.

  PMID: 16160131 BACKGROUND

• 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. doi: 10.1016/s0360-3016(02)04612-6.

  PMID: 12738318 BACKGROUND

• 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. doi: 10.1016/s0360-3016(99)00443-5.

  PMID: 10661346 BACKGROUND

• 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. doi: 10.1016/0360-3016(96)00204-0.

  PMID: 8751412 BACKGROUND

• 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. doi: 10.1016/s0360-3016(98)00248-x.

  PMID: 9806528 BACKGROUND

• 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. doi: 10.1016/s0360-3016(03)00290-6.

  PMID: 12873664 BACKGROUND

• 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. doi: 10.1016/j.ijrobp.2005.07.973.

  PMID: 16253772 BACKGROUND

• 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. doi: 10.1016/j.ijrobp.2005.12.033. Epub 2006 Mar 20.

  PMID: 16545919 BACKGROUND

• 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. doi: 10.1016/j.ijrobp.2004.11.009.

  PMID: 15708277 BACKGROUND

• 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. doi: 10.1016/j.ijrobp.2007.03.030. Epub 2007 May 21.

  PMID: 17513060 BACKGROUND

• 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. doi: 10.1016/S1053-4296(03)00031-6.

  PMID: 12903007 BACKGROUND

• 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. doi: 10.1016/s0090-4295(00)00858-x.

  PMID: 11113727 BACKGROUND

• 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.

  PMID: 18354103 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Constantine Mantz, MD

  GenesisCare USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 17, 2008
• Study Start: July 1, 2008
• Study Completion: September 1, 2009
• Last Updated: April 30, 2012

Record last verified: 2012-04

Locations

US (4)