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Quantification of Respiratory-induced Prostate Motion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980993
Recruitment Status : Withdrawn (Lack of enrollment.)
First Posted : September 21, 2009
Last Update Posted : November 4, 2019
Information provided by (Responsible Party):
Oregon Health and Science University

Brief Summary:
Patient anatomy and position during the course of radiation therapy can vary from those used for treatment planning; a function of patient movement, uncertainty in positioning system, and organ motion. Traditionally, treatment margins are designed to compensate for interfraction prostate setup variability. This approach has the potential to lower the overall effectiveness of treatment because the prostate gland is a continuously moving target whose motion cannot be accurately accounted for solely on the basis of interfraction movement. More recently, the dosimetric relevance of intra-fraction prostate motion has been recognized, and may be compensated for by continuous real-time adaptive radiation therapy afforded by the Calypso 4D Localization System™. In the current study, the investigators propose to characterize intrafraction prostate motion. The investigators hypothesize that intrafraction prostate motion is correlated with respiratory motion.

Condition or disease
Prostate Cancer

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study on the Quantification of Respiratory-induced Prostate Motion During Radiation Therapy Using Continuous Real-time Tracking
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Motion amplitude [ Time Frame: Continuously during radiation administration (generally 8 to 15 minutes in duration) ]
    Measured at frequency of 10Hz

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Localized prostate cancer patients undergoing intensity-modulated radiation therapy.

Inclusion Criteria:

  • Histologically confirmed stage I-III adenocarcinoma of the prostate gland
  • Age > 18 years. Males of all races and ethnic groups
  • Scheduled to receive radiation for definitive therapy
  • Three (3) electromagnetic transponders implanted into prostate gland

Exclusion Criteria:

  • Does not satisfy inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00980993

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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
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Principal Investigator: James A. Tanyi, Ph.D. Oregon Health and Science University
Additional Information:
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Responsible Party: Oregon Health and Science University Identifier: NCT00980993    
Other Study ID Numbers: OHSU IRB00005606
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Keywords provided by Oregon Health and Science University:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases