Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences

NCT ID: NCT01355185

Last Updated: 2014-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-06-30

Brief Summary

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There are substantial uncertainties with contemporary seed placement techniques in prostate brachytherapy, particularly with the impact of seed movement after an implant due to edema and migration of seeds in the prostate and peri-prostatic tissues. This study will accrue 20 patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these phenomena.

Detailed Description

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Prostate brachytherapy is an effective treatment option for men with localized prostate cancer with excellent cure rates and a favorable toxicity profile. Having a more detailed understanding of seed movement after an implant will provide clinicians with details about the clinical impact of these phenomena on implants and provide the detailed understanding of these phenomena that are necessary for more sophisticated brachytherapy implants that are envisioned in the future.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* treated with prostate brachytherapy
* low risk or intermediate risk prostate cancer
* ambulatory
* stable medical condition
* 18 years of age or older
* capable of informed consent

Exclusion Criteria

* no use of any hormonal therapy
* unable to have MRI scans (ie. presence of metallic foreign object, aneurysm clip, cardiac pacemaker, internal wires, implanted pump, implanted cardiac device, claustrophobia, etc.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Association of Radiation Oncology

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nawaid Usmani, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Ronald Sloboda, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Nawaid Usmani, MD, FRCPC

Role: CONTACT

780-432-8518

Ronald Sloboda, PhD

Role: CONTACT

780-432-8719

Facility Contacts

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Nawaid Usmani, MD, FRCPC

Role: primary

780-432-8518

Ron Sloboda, PHD

Role: backup

780-432-8719

References

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Sloboda RS, Usmani N, Pedersen J, Murtha A, Pervez N, Yee D. Time course of prostatic edema post permanent seed implant determined by magnetic resonance imaging. Brachytherapy. 2010 Oct-Dec;9(4):354-61. doi: 10.1016/j.brachy.2009.09.008. Epub 2010 Jan 29.

Reference Type BACKGROUND
PMID: 20116344 (View on PubMed)

Other Identifiers

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25750

Identifier Type: -

Identifier Source: org_study_id

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