Cone Beam CT for Daily Image Guidance - Prostate Cancer | NCT00188786

Studies
Cone Beam CT for Daily Image Guidance - Prostate Cancer

NCT00188786

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Feb 15, 2011Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Prostatic Neoplasms

Interventions

daily Cone Beam CT for imaging guidance for radiotherapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2011

Last Update Posted Date

Feb 15, 2011Estimated

Name	Class
Princess Margaret Hospital, Canada	OTHER

Description Module

Brief Summary

Conformal dose escalated radiation therapy (CRT) is standard treatment for patients with low and intermediate risk prostate cancer. CRT requires accurate daily localization of the prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone Beam CT also provides important information on daily position of organs within the pelvis. This study aims to assess the feasibility of cone beam CT for daily localization of the prostate as well as document changes in size and location of pelvic organs during an entire course of CRT.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
daily Cone Beam CT for imaging guidance for radiotherapy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving conformal radiation therapy for prostate cancer.

Secondary Outcomes

Measure	Description	Time Frame
To measure the amount of interfraction movement of the prostate and seminal vesicles with current bowel regimen of daily milk of magnesia.
To measure the amount of interfraction movement and deformity of the rectum and bladder with current bowel regimen of daily milk of magnesia.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of adenocarcinoma of the prostate
Patient undergoing dose escalated conformal external beam radiation therapy
Low or intermediate risk prognostic factors (PSA 20 or less, Gleason score <8, Clinical T category \

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Catton, MD	Princess Margaret Hospital, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princess Margaret Hospital		Toronto	Ontario	M5G 2M9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided