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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01355185
• Other study ID #: 25750
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2011
• Last updated: October 1, 2014
• Start date: August 2011
• Est. completion date: June 2015

Study information

• Verified date: October 2014
• Source: AHS Cancer Control Alberta
• Contact: Nawaid Usmani, MD, FRCPC
• Phone: 780-432-8518
• Email: Nawaid.Usmani[@]albertahealthservices.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Canadian Association of Radiation Oncology, Sanofi

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation