Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

NCT ID: NCT00188799

Last Updated: 2015-07-16

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-11-30

Brief Summary

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Conformal dose escalated radiotherapy was adopted as the standard treatment technique at PMH for intermediate risk patients with localised disease in 1997. This technique provides a much smaller margin of error for treatment set-up and delivery than with conventional techniques. One way to ensure the accuracy of treatment delivery is to image the prostate position daily, prior to therapy, to allow for appropriate set-up corrections. To do so, imaging markers are implanted into the prostate under guided ultrasound (a standard procedure at PMH). However, there are disadvantages in using imaging markers which include added time to the treatment planning process, and an invasive procedure with a potential for discomfort, bleeding and infection. This study will investigate and compare X-ray volume imaging to the gold standard imaging markers.

Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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daily Xray volume imaging for planning radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of adenocarcinoma of the prostate
* Patient undergoing escalated dose conformal external beam radiotherapy.
* Patient has low or intermediate risk prognostic factors: all of PSA \<21, Gleason score \<8, clinical T category \<T3, clinical N category 0 or X, M category 0 or X.
* Informed consent

Exclusion Criteria

* No diagnosis of adenocarcinoma of the prostate
* Patient not undergoing escalated dose conformal radiotherapy
* Patient does not have low or intermediate risk prognostic factors
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

Canadian Association of Radiation Oncology

INDUSTRY

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Catton, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Abbott-CARO Uro-OncologicAward

Identifier Type: -

Identifier Source: secondary_id

UHN REB 03-0483-CE

Identifier Type: -

Identifier Source: org_study_id

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